{ "source": "HPRA: human medicines authorised in Ireland", "attribution": "Source: Health Products Regulatory Authority (HPRA), CC BY 4.0.", "licence": "CC BY 4.0 (published on data.gov.ie)", "retrieved": "2026-10-13T06:01:59+00:00", "count": 10297, "records": [ { "licence_number": "DPR1328/016/002", "product_name": "INSPRA", "holder": "B & S Healthcare", "authorised_date": "2009-03-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "DPR1596/008/001", "product_name": "Prozac", "holder": "Clear Pharmacy", "authorised_date": "2009-07-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB", "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "EMEA/H/D/000002", "product_name": "Steen solution", "holder": "Det Norske Veritas Certification AS", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [], "active_substances": [ "Human serum albumin" ], "routes": [], "dispensing_status": [ "*** AWAITING VALUE ***" ], "supply_status": "", "legal_basis": "Not Currently Available" }, { "licence_number": "EU/01/07/418/013", "product_name": "Celsentri 20mg/ ml oral solution", "holder": "ViiV Healthcare BV", "authorised_date": "2017-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "J05AX", "J05AX09" ], "active_substances": [ "Maraviroc" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/01/13/878/001", "product_name": "Defitelio 80 mg/mL concentrate for solution for infusion", "holder": "Gentium S.p.A.", "authorised_date": "2013-10-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B01AX", "B01AX01" ], "active_substances": [ "Defibrotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1//06/343/01", "product_name": "Baraclude", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF", "J05AF10" ], "active_substances": [ "Entecavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/129/001", "product_name": "Azopt 10 mg/ml eye drops, suspension", "holder": "Novartis Europharm Limited", "authorised_date": "2000-03-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01EC", "S01EC04" ], "active_substances": [ "Brinzolamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/129/002", "product_name": "Azopt 10 mg/ml eye drops, suspension", "holder": "Novartis Europharm Limited", "authorised_date": "2000-03-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01EC", "S01EC04" ], "active_substances": [ "Brinzolamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/130/001", "product_name": "Orgalutran 0.25 mg/0.5 mL solution for injection", "holder": "N.V. Organon", "authorised_date": "2000-05-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01CC", "H01CC01" ], "active_substances": [ "Ganirelix" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/130/002", "product_name": "Orgalutran 0.25 mg/0.5 mL solution for injection", "holder": "N.V. Organon", "authorised_date": "2000-05-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01CC", "H01CC01" ], "active_substances": [ "Ganirelix" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/133/033-035", "product_name": "Toujeo (previously Optisulin) 300 units/ml SoloStar solution for injection in a pre-filled pen", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/134/001", "product_name": "Lantus 100 units/ml solution for injection in a vial", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/134/002", "product_name": "Lantus 100 units/ml solution for injection in a vial", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "2000-06-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/134/003", "product_name": "Lantus 100 units/ml solution for injection in a vial", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "2000-06-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply 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"registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/134/006", "product_name": "Lantus 100 units/ml solution for injection in a cartridge", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "2000-06-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/134/007", "product_name": "Lantus 100 units/ml solution for injection in a cartridge", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "2000-06-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/134/030-037", "product_name": "Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "2000-06-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/135/001-002", "product_name": "DaTSCAN 74 MBq/ml solution for injection", "holder": "GE Healthcare B.V.", "authorised_date": "2000-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AB", "V09AB03" ], "active_substances": [ "Ioflupane" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/140/001", "product_name": "Visudyne 15 mg powder for solution for infusion", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2000-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "S01LA", "S01LA01" ], "active_substances": [ "Verteporfin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/141/001", "product_name": "Myocet liposomal 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2000-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder, dispersion and solvent for concentrate for dispersion for infusion", "atc_codes": [ "L01DB", "L01DB01" ], "active_substances": [ "DOXORUBICIN HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/142/004-05", "product_name": "NovoMix 30 Penfill 100 units/ml suspension for injection in cartridge", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/142/09-010", "product_name": "NovoMix 30 FlexPen 100 units/ml suspension for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD06" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/142/11-13", "product_name": "NovoMix 50 Penfill 100 units/ml suspension for injection in cartridge", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD06" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/142/14-16", "product_name": "NovoMix 50 FlexPen 100 units/ml suspension for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD06" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/001", "product_name": "KOGENATE Bayer", "holder": "Bayer AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa", "R-dna (baby hamster kidney expression system)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/002", "product_name": "Kogenate Bayer", "holder": "Bayer Schering Pharma AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/003", "product_name": "Kogenate Bayer", "holder": "Bayer Schering Pharma AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/004", "product_name": "KOGENATE BAYER", "holder": "Bayer Schering Pharma AG", "authorised_date": "2000-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/005", "product_name": "Kogenate Bayer", "holder": "Bayer Schering Pharma AG", "authorised_date": "2004-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/006", "product_name": "Kogenate Bayer", "holder": "Bayer Schering Pharma AG", "authorised_date": "2004-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/012-013", "product_name": "Kogenate Bayer", "holder": "Bayer Schering Pharma AG", "authorised_date": "2010-08-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/143/10-11", "product_name": "Kogenate Bayer", "holder": "Bayer Schering Pharma AG", "authorised_date": "2007-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/145/001", "product_name": "Herceptin 150 mg powder for concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2000-08-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/00/145/002", "product_name": "Herceptin 600 mg solution for injection in vial", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XC", "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject 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"Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/01/194/001", "product_name": "INOmax", "holder": "AGA AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "R07AX", "R07AX01" ], "active_substances": [ "Nitric oxide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/01/194/003-004", "product_name": "INOmax 400 ppm mol/mol medicinal gas, compressed", "holder": "INO Therapeutics AB", "authorised_date": "2011-03-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "R07AX", "R07AX01" ], 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"product_name": "Liprolog Mix50 Pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2001-08-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/01/195/028-029", "product_name": "Liprolog", "holder": "Eli Lilly and Company Limited", "authorised_date": "2014-10-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/01/195/22-27", "product_name": "Liprolog", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2008-07-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/01/196/001", "product_name": "Cancidas 50 mg powder for concentrate for solution for infusion", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2001-10-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/226/001", "product_name": "InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix", "holder": "Medtronic BioPharma B.V.", "authorised_date": "2002-09-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder, solvent and matrix for implantation matrix", "atc_codes": [ "M05BC", "M05BC01" ], "active_substances": [ "Dibotermin alfa" ], "routes": [ "Implantation" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/227/001-002", "product_name": "Neulasta 6 mg solution for injection", "holder": "Amgen Europe B.V.,", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AA", "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/229/001-035", "product_name": "Actraphane", "holder": "Novo Nordisk A/S", "authorised_date": "2002-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Insulin human" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/229/036-037", "product_name": "Actraphane 30 40 IU/ml Suspension for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2003-08-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Insulin human", "Insulin human" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/230/001-015", "product_name": "Actrapid", "holder": "Novo Nordisk A/S", "authorised_date": "2002-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB", "A10AB01" ], "active_substances": [ "Insulin human" ], "routes": [ "Subcutaneous 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Insulin human", "Insulin human" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/231/1-25", "product_name": "Mixtard", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Insulin human" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/233/003-004", "product_name": "Insulatard 100 international units/ml suspension for injection in vial", "holder": "Novo Nordisk A/S", "authorised_date": "2003-08-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Insulin human" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/233/005-007", "product_name": "Insulatard Penfill", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Insulin 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"registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Insulin human" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/233/1-15", "product_name": "Insulatard", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Insulin human" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/234/016-017", "product_name": "Protaphane", "holder": "Novo Nordisk A/S", "authorised_date": "2003-08-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Insulin human" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/234/1-15", "product_name": "Protaphane", "holder": "Novo Nordisk A/S", "authorised_date": "2002-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AB", "A10AB01" ], "active_substances": [ "Insulin human" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/237/006", "product_name": "Cialis 2.5 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2007-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/237/1-5", "product_name": "CIALIS", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/237/7-8", "product_name": "Cialis 5 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2007-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/238/001", "product_name": "Zavesca 100 mg capsules", "holder": "Advanz Pharma Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX", "A16AX06" ], "active_substances": [ "Miglustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/240/009-010", "product_name": "Somavert 25 mg powder and solvent for solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2015-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AX01" ], "active_substances": [ "Pegvisomant" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/240/011-012", "product_name": "Somavert 30 mg powder and solvent for solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2015-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AX01" ], "active_substances": [ "Pegvisomant" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/240/1-3", "product_name": "Somavert", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2002-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AX01" ], "active_substances": [ "Pegvisomant" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/02/246/1-2", "product_name": "Carbaglu 200 mg dispersible tablets", "holder": "Recordati Rare Diseases", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "A16AA", "A16AA05" ], "active_substances": [ "Carglumic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/247/01-2", "product_name": "Forsteo 20 micrograms/80 microliters solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2003-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H05AA", "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/248/013-15", "product_name": "Levitra 10 mg orodispersible tablets", "holder": "Bayer Schering Pharma AG", "authorised_date": "2010-09-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "G04BE", "G04BE09" ], "active_substances": [ "VARDENAFIL HYDROCHLORIDE TRIHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/248/1-12", "product_name": "LEVITRA", "holder": "Bayer AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE09" ], "active_substances": [ "Vardenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/252/001", "product_name": "Fuzeon", "holder": "Roche Registration GmbH", "authorised_date": "2003-05-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J05AX", "J05AX07" ], "active_substances": [ "Enfuvirtide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/253/01-3", "product_name": "Aldurazyme 100 U/ml concentrate for solution for infusion", "holder": "Sanofi B.V.", "authorised_date": "2003-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "A16AB", "A16AB05" ], "active_substances": [ "Laronidase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/255/009-010,012", "product_name": "Ventavis 20 microgram/ml nebuliser solution", "holder": "Bayer Pharma AG", "authorised_date": "2014-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "B01AC", "B01AC11" ], "active_substances": [ "Iloprost trometanol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/255/1-3", "product_name": "Ventavis 10 microgram/ml nebuliser solution", "holder": "Bayer AG", "authorised_date": "2003-09-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "B01AC", "B01AC11" ], "active_substances": [ "Iloprost trometanol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/256/020", "product_name": "Humira 80 mg solution for injection in pre-filled syringe", "holder": "AbbVie Deutschland GmbH & Co. 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combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/260/005-008,14,17", "product_name": "Stalevo", "holder": "Orion Corporation", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/260/009-012,15,18", "product_name": "Stalevo", "holder": "Orion Corporation", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [], "routes": [], "dispensing_status": [ "Product subject to prescription which may be 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"Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Carbidopa", "Entacapone", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/260/24-28", "product_name": "Stalevo 75 mg/18.75 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Carbidopa monohydrate", "Levodopa", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/260/29-33", "product_name": "Stalevo 125 mg/31.25 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Carbidopa monohydrate", "Entacapone", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/261/1-3", "product_name": "Emtriva 200 mg hard capsules", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2003-10-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", 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"atc_codes": [ "J07AE", "J07AE01" ], "active_substances": [ "Cholera vaccine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/264/001", "product_name": "Zevalin", "holder": "Ceft Biopharma s.r.o", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V10XX", "V10XX02" ], "active_substances": [ "Ibritumomabum tiuxetan" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/265/3-4", "product_name": "Bonviva 150 mg film-coated 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"supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/267/01-7", "product_name": "Reyataz", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J05AE", "J05AE08" ], "active_substances": [ "Atazanavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/267/012", "product_name": "Reyataz 50 mg oral powder", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2016-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder", "atc_codes": [ "J05AE", "J05AE08" ], "active_substances": [ "Atazanavir sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/267/8-9", "product_name": "Reyataz 300 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2008-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J05AE", "J05AE08" ], "active_substances": [ "Atazanavir sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/268/1-3", "product_name": "Cholestagel 625 mg film-coated 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"Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/270/004-005", "product_name": "Kentera", "holder": "Teva B.V.", "authorised_date": "2011-08-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel in sachet", "atc_codes": [ "G04BD", "G04BD04" ], "active_substances": [ "Oxybutynin hydrochloride" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/270/1-2", "product_name": "Kentera 3.9 mg/24 hours transdermal patch", "holder": "Teva B.V.", "authorised_date": "2004-08-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G04BD", "G04BD04" ], "active_substances": [ "Oxybutynin" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/001", "product_name": "Advate 250 IU/5 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "2004-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/002", "product_name": "Advate 500 IU/5 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "2008-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/003", "product_name": "Advate 1000 IU/5 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "2008-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/004", "product_name": "Advate 1500 IU/5 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/005", "product_name": "Advate 2000 IU/5 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/006", "product_name": "Advate 3000 IU/5 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/03/271/007", "product_name": "Advate 250 IU/2 ml powder and solvent for solution for injection", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Recombinant coagulation fviii (octocog alfa)" ], "routes": [ "Intravenous 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], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/273/001", "product_name": "Lysodren 500mg tablets", "holder": "Esteve Pharmaceuticals S.A.", "authorised_date": "2004-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XX", "L01XX23" ], "active_substances": [ "Mitotane" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/274/001", "product_name": "Velcade 3.5 mg powder for solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2004-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX", "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/274/002", "product_name": "Velcade 1 mg powder for solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX", "L01XX32" ], "active_substances": [ "Ps-341 as boronic acid (bortezomib)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/275/001-002", "product_name": "Litak 2 mg/ml solution for injection", "holder": "Lipomed GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BB", "L01BB04" ], "active_substances": [ "Cladribine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/276/001-005", "product_name": "Abilify 5 mg tablets", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", 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"EU/1/04/280/001", "product_name": "Yentreve 20 mg hard gastro-resistant capsules", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX", "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/280/1-6", "product_name": "Yentreve", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX", "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01EB16" ], "active_substances": [ "Ibuprofen" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/285/021-036", "product_name": "Apidra 100 Units/ml Solution for injection", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "2010-01-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB", "A10AB06" ], "active_substances": [ "Insulin glulisine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/290/001", "product_name": "Alimta 500 mg powder for concentrate for solution for infusion", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2004-10-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/290/002", "product_name": "Alimta", "holder": "Eli Lilly Nederland B.V.", 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BG08" ], "active_substances": [ "Ziconotide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/302/1-3", "product_name": "PRIALT", "holder": "Esteve Pharmaceuticals GmbH", "authorised_date": "2005-02-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BG", "N02BG08" ], "active_substances": [ "Ziconotide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/303/004", "product_name": "Orfadin 20 mg hard capsules", "holder": "Swedish Orphan Biovitrum AB", "authorised_date": "2015-05-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX", "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/303/005", "product_name": "Orfadin 4 mg/ml oral suspension", "holder": "Swedish Orphan Biovitrum AB", "authorised_date": "2015-06-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A16AX", "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Rasagiline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/305/001-002", "product_name": "Truvada 200 mg/245 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Emtricitabine", "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/306/001", "product_name": "Aloxi 250 micrograms solution for injection", "holder": "Helsinn Birex Pharmaceuticals Limited", "authorised_date": "2005-03-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA05" ], "active_substances": [ "Palonosetron (as hydrochloride)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/306/002-003", "product_name": "Aloxi 500 micrograms soft capsules", "holder": "Helsinn Birex Pharmaceuticals Limited", "authorised_date": "2010-05-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A04AA", "A04AA05" ], "active_substances": [ "Palonosetron (as hydrochloride)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/307/001", "product_name": "Zonegran 25 mg hard capsules", "holder": "Amdipharm Limited", "authorised_date": "2005-03-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/307/003", "product_name": "Zonegran 50 mg hard capsules", "holder": "Amdipharm Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/04/307/004", "product_name": "Zonegran 100 mg hard capsules", "holder": "Amdipharm Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/308/001", "product_name": "Aclasta 5 mg solution for infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "M05BA", "M05BA08" ], "active_substances": [ "Zoledronic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/310/1-4", "product_name": "Fosavance 70 mg/2800 IU tablets", "holder": "N.V. 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"Erlotinib hydrochloride" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "EU/1/05/312/001", "product_name": "Xyrem 500 mg/mL oral solution", "holder": "UCB Pharma S.A.", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07XX04" ], "active_substances": [ "Sodium Oxybate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/315/001", "product_name": "Aptivus 250 mg soft capsules", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2005-10-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "J05AE", "J05AE09" ], "active_substances": [ "Tipranavir" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/316/1-7", "product_name": "Procoralan 5 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/316/8-14", "product_name": "Procoralan 7.5 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/317/1-7", "product_name": "Corlentor 5 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/318/002", "product_name": "Revatio 0.8 mg/ml solution for injection", "holder": "Upjohn EESV", "authorised_date": "2009-12-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil citrate for parenteral use" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/318/003", "product_name": "Revatio 10 mg/ml powder for oral suspension", "holder": "Upjohn EESV", "authorised_date": "2012-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/319/001", "product_name": "Xolair 75 mg powder and solvent for solution for injection", "holder": "Novartis Europharm Limited", "authorised_date": "2005-10-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "R03DX", "R03DX05" ], 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"product_name": "Xolair 300 mg solution for injection in pre-filled syringe", "holder": "Novartis Europharm Limited", "authorised_date": "2023-11-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "R03DX05" ], "active_substances": [ "Omalizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/319/015-017", "product_name": "Xolair 300 mg solution for injection in pre-filled pen", "holder": "Novartis Europharm Limited", "authorised_date": "2023-11-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "R03DX05" ], "active_substances": [ 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"HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J02AC", "J02AC04" ], "active_substances": [ "Posaconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/320/005", "product_name": "Noxafil 300 mg gastro-resistant powder for oral suspension", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2022-02-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant powder for oral suspension", "atc_codes": [ "J02AC04" ], "active_substances": [ "Posaconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX", "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/329/001-006", "product_name": "Kiovig 100 mg/ml solution for infusion", "holder": "Baxter AG", "authorised_date": "2006-01-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/330/5-11", "product_name": "Rotarix oral suspension in pre-filled oral applicator", "holder": "GlaxoSmithKline Biologicals S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for oral suspension", "atc_codes": [ "J07BH", "J07BH01" ], "active_substances": [ "Human rotavirus, live attenuated" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/331/1-3,14-20", "product_name": "Neupro", "holder": "UCB Pharma S.A.", "authorised_date": "2006-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N04BC", "N04BC09" ], "active_substances": [ "Rotigotine" ], "routes": [ "Not Currently 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"dosage_form": "Transdermal patch", "atc_codes": [ "N04BC", "N04BC09" ], "active_substances": [ "Rotigotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/331/4-6,21-25", "product_name": "Neupro", "holder": "Schwarz Pharma Limited", "authorised_date": "2006-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N04BC" ], "active_substances": [ "Rotigotine" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/331/47-55", "product_name": "Neupro", "holder": "UCB Pharma S.A.", "authorised_date": "2008-08-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N04BC", "N04BC09" ], "active_substances": [ "Rotigotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/05/331/7-9,26-31", "product_name": "Neupro", "holder": "Schwarz Pharma Limited", "authorised_date": "2006-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N04BC" ], "active_substances": [ "Rotigotine" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/332/001", "product_name": "Omnitrope 1.3mg/ ml Powder and solvent for solution for injection", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/332/002-003", "product_name": "Omnitrope 5mg/ ml Powder and solvent for solution for injection", "holder": "Sandoz GmbH", "authorised_date": "2006-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/332/004-006", "product_name": "Omnitrope 5 mg/1.5 ml solution for injection in cartridge", "holder": "Sandoz GmbH", "authorised_date": "2007-04-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of 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"atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/333/1-3", "product_name": "Myozyme 50 mg powder for concentrate for solution for infusion", "holder": "Sanofi B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "A16AB", "A16AB07" ], "active_substances": [ "Alglucosidase alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/334/01-05", "product_name": "Evoltra 1 mg/ml concentrate for solution for infusion", "holder": "Sanofi B.V.", "authorised_date": "2006-11-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BB", "L01BB06" ], "active_substances": [ "Clofarabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/336/01", "product_name": "Tygacil 50 mg powder for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2006-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01AA", "J01AA12" ], "active_substances": [ "Tigecycline" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/337/1-13", "product_name": "M-M-RvaxPro powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2006-05-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "J07BD", "J07BD52" ], "active_substances": [ "Mumps virus live attenuated jeryl lynn strain", "Rubella virus (wistar ra 27/3 strain) live attenuated", "Measles virus live attenuated derived from the edmonston b strain" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/338/001-003", "product_name": "Duotrav (Extravan) 40 micrograms/mL + 5 mg/mL eye drops, solution", "holder": "Novartis Europharm Limited", "authorised_date": "2006-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Travopost", "Timolol", "Timolol Maleate" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/340/001-002", "product_name": "Ganfort 0.3 mg/ml + 5 mg/ml eye drops, solution", "holder": "AbbVie Deutschland GmbH & Co. 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"holder": "Biogen Netherlands B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA23" ], "active_substances": [ "Natalizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/346/002", "product_name": "Tysabri 150 mg solution for injection in pre-filled syringe", "holder": "Biogen Netherlands B.V.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AA23" ], "active_substances": [ "Natalizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription 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"dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE04" ], "active_substances": [ "Sunitinib malate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/347/003", "product_name": "Sutent 50 mg hard capsules", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2006-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE04" ], "active_substances": [ "Sunitinib malate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/347/7-8", "product_name": "Sutent 37.5 mg hard capsules", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2009-05-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE04" ], "active_substances": [ "Sunitinib malate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/348/01", "product_name": "RotaTeq oral solution Rotavirus vaccine (live)", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2006-06-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "J07BH", "J07BH02" ], "active_substances": [ "Rotavirus vaccine, live, pentavalent gi", "Rotavirus vaccine, live, pentavalent g2", "Rotavirus 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"dosage_form": "Sublingual film", "atc_codes": [ "N07BC51" ], "active_substances": [ "Buprenorphine hydrochloride", "Naloxone hydrochloride dihydrate" ], "routes": [ "Buccal use", "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/359/013-015", "product_name": "Suboxone 8 mg/2 mg Sublingual film", "holder": "Indivior Europe Limited", "authorised_date": "2020-07-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual film", "atc_codes": [ "N07BC51" ], "active_substances": [ "Buprenorphine hydrochloride", "Naloxone hydrochloride dihydrate" ], "routes": [ "Buccal use", "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/363/014-015", "product_name": "Sprycel 140 mg film-coated tablets", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2010-10-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/363/016", "product_name": "Sprycel 10 mg/mL powder for oral suspension", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2018-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "L01XE", "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/06/363/1-4-7", "product_name": "Sprycel 20 mg film-coated tablets", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2006-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], 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"holder": "Astellas Pharma Europe BV", "authorised_date": "2009-04-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/387/3-6", "product_name": "Advagraf 1 mg prolonged-release hard capsules", "holder": "Astellas Pharma Europe BV", "authorised_date": "2007-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not 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"Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AA", "L04AA24" ], "active_substances": [ "Abatacept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/389/011-012", "product_name": "Orencia 125 mg solution for injection in pre-filled pen", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2007-05-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AA24" ], "active_substances": [ "Abatacept" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/389/013", "product_name": "Orencia 50 mg solution for injection in pre-filled syringe", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2019-04-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AA24" ], "active_substances": [ "Abatacept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/389/014", "product_name": "Orencia 87.5 mg solution for injection in pre-filled syringe", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2019-04-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AA24" ], "active_substances": [ "Abatacept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/389/1-3", "product_name": "Orencia 250 mg powder for concentrate for solution for infusion", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA24" ], "active_substances": [ "Abatacept" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/001", "product_name": "Revlimid 5 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/002", "product_name": "Revlimid 10 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2007-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/003", "product_name": "Revlimid 15 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2007-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/004", "product_name": "Revlimid 25 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2007-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/005", "product_name": "Revlimid 2.5 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2012-09-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/006", "product_name": "Revlimid 7.5 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2012-09-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/391/009", "product_name": "Revlimid 20 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2015-02-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" 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"Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/395/6-10", "product_name": "INVEGA 6 mg prolonged-release tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2007-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/396/004", "product_name": "Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen", "holder": "Merck Europe B.V.", "authorised_date": "2017-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA", "G03GA30" ], "active_substances": [ "Lutropin alfa", "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/396/005", "product_name": "Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen", "holder": "Merck Europe B.V.", "authorised_date": "2017-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA", "G03GA30" ], "active_substances": [ "Lutropin alfa", "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/396/006", "product_name": "Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen", "holder": "Merck Europe B.V.", "authorised_date": "2017-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA", "G03GA30" ], "active_substances": [ "Lutropin alfa", "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX05" ], "active_substances": [ "Hydroxycarbamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/397/002-004", "product_name": "Siklos 100 mg film-coated tablet", "holder": "Theravia", "authorised_date": "2011-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX05" ], "active_substances": [ "Hydroxycarbamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/399/001-006", "product_name": "Aerinaze 2.5 mg/120 mg modified-release tablets", "holder": "N.V. Organon", "authorised_date": "2007-07-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "R01BA", "R01BA52" ], "active_substances": [ "Pseudoephedrine sulfate", "Desloratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/008", "product_name": "Mircera 50 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/009", "product_name": "Mircera 75 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/10", "product_name": "Mircera 100 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/11", "product_name": "Mircera 150 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin 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"EU/1/07/400/13", "product_name": "Mircera 250 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/17", "product_name": "Mircera 30 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/20", "product_name": "Mircera 120 micrograms/0.3 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/400/21", "product_name": "Mircera 360 micrograms/0.6 ml solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA03" ], "active_substances": [ "Methoxy peg-epoetin beta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/401/12-15", "product_name": "Alli", "holder": "GlaxoSmithKline Dungarvan Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A08AB", "A08AB01" ], "active_substances": [ "Orlistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/401/7-11", "product_name": "Alli 60 mg hard capsules", "holder": "GlaxoSmithKline Dungarvan Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A08AB", "A08AB01" ], "active_substances": [ "Orlistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/402/001", "product_name": "Increlex 10 mg/ml solution for injection", "holder": "Esteve Pharmaceuticals S.A.", "authorised_date": "2007-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01AC", "H01AC03" ], "active_substances": [ "Mecasermin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/403/001", "product_name": "ATRIANCE 5mg/ml Solution for Infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "2007-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "L01BB", "L01BB07" ], "active_substances": [ "Nelarabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/404/006-008", "product_name": "Flebogamma DIF 100 mg/ml solution for infusion", "holder": "Instituto Grifols S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA02" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/404/1-5", "product_name": "Flebogamma DIF 50 mg/ml solution for infusion", "holder": "Instituto Grifols S.A.", "authorised_date": "2007-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/405/021-030", "product_name": "Rasilez 150 mg film-coated tablets", "holder": "Lxo Ireland Designated Activity Company", "authorised_date": "2007-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09XA02" ], "active_substances": [ "Aliskiren hemifumarate" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/405/031-040", "product_name": "Rasilez 300 mg film-coated tablets", "holder": "Noden Pharma DAC", "authorised_date": "2007-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09XA", "C09XA02" ], "active_substances": [ "Aliskiren hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/1-2", "product_name": "Binocrit 1 000 IU/0.5 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2007-08-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Recombinant human erythropoietin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/11-12", "product_name": "Binocrit 6 000 IU/0.6 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Recombinant human erythropoietin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/13-014", "product_name": "Binocrit 8 000 IU/0.8 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Recombinant human erythropoietin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/15-16", "product_name": "Binocrit 10 000 IU/1 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Recombinant human erythropoietin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/21-22", "product_name": "Binocrit 20 000 IU/0.5 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Epoetin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which 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"holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Epoetin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/3-4", "product_name": "Binocrit 2 000 IU/1 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Recombinant human erythropoietin alfa" ], "routes": [ "Intravenous 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"EU/1/07/410/7-8", "product_name": "Binocrit 4 000 IU/0.4 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Recombinant human erythropoietin alfa" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/410/9-10", "product_name": "Binocrit 5 000 IU/0.5 mL solution for injection in a pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled 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"dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/427/31-34", "product_name": "Olanzapine Teva 15 mg Orodispersible tablet", "holder": "Teva Pharma B.V.", "authorised_date": "2007-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/427/35-37", "product_name": "Olanzapine Teva 20 mg Orodispersible tablet", "holder": "Teva Pharma B.V.", "authorised_date": "2007-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/428/001", "product_name": "Abraxane 5 mg/ml powder for dispersion for infusion", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2008-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for dispersion for infusion", "atc_codes": [ "L01CD", "L01CD01" ], "active_substances": [ "Paclitaxel" 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"Retacrit", "holder": "Pfizer Europe MA EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Epoetin zeta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/431/7-16", "product_name": "Retacrit", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2007-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], "active_substances": [ "Epoetin zeta" ], "routes": [ "Intravenous use", "Subcutaneous use" ], 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"dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX", "J05AX08" ], "active_substances": [ "Raltegravir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/436/1-2", "product_name": "Isentress 400 mg Film-coated tablet", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2007-12-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX", "J05AX08" ], "active_substances": [ "Raltegravir potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/437/003-004", "product_name": "Ivemend 150 mg Powder for solution for infusion", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2010-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "A04AD", "A04AD12" ], "active_substances": [ "Fosaprepitant dimeglumine" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/07/438/1-2", "product_name": "Myfenax 250 mg Capsule, hard", "holder": "Teva B.V.", "authorised_date": "2008-02-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], 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"2008-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Buccal tablet", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "FENTANYL CITRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/441/7-8", "product_name": "Effentora 600 micrograms buccal tablets", "holder": "Phoenix Labs", "authorised_date": "2008-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Buccal tablet", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "FENTANYL CITRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application 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"AU", "dosage_form": "Coated granules", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/442/030", "product_name": "Pradaxa 150 mg coated granules", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2021-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated granules", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/442/1-4", "product_name": "Pradaxa 75 mg hard capsules", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2008-03-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE", "B01AE07" ], "active_substances": [ "Dabigatran etexilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/442/5-8", "product_name": "Pradaxa 110 mg hard capsules", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE", "B01AE07" ], "active_substances": [ "Dabigatran etexilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/443/1", "product_name": "Thalidomide BMS 50 mg hard capsules", "holder": "Bristol-Myers Squibb Pharmaceuticals uc", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX02" ], "active_substances": [ "Thalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/444/1-4", "product_name": "Ratiograstim 30 MIU/0.5 ml solution for injection", "holder": "Ratiopharm GmbH", "authorised_date": "2008-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/444/5-8", "product_name": "Ratiograstim 48 MIU/0.8 ml solution for injection", "holder": "Ratiopharm GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/446/1-3", "product_name": "Privigen 100 mg/ml solution for infusion", "holder": "CSL Behring GmbH", "authorised_date": "2008-04-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/448/001", "product_name": "Mycamine 50 mg powder for concentrate for solution for infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AX", "J02AX05" ], "active_substances": [ "Micafungin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/448/002", "product_name": "Mycamine 100 mg powder for solution for infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AX", "J02AX05" ], "active_substances": [ "Micafungin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/451/001-002", "product_name": "Volibris 5 mg film-coated tablets", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/451/003-004", "product_name": "Volibris 10 mg film-coated tablets", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2008-04-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/451/005", "product_name": "Volibris 2.5 mg film-coated tablet", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2021-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/455/008-014", "product_name": "Janumet 50 mg/1000 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/455/1-7", "product_name": "Janumet 50 mg/850 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/456/1-7", "product_name": "Velmetia 50 mg/850 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/456/8-14", "product_name": "Velmetia 50 mg/1000 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/457/1-7", "product_name": "Efficib 50 mg/850 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/457/8-14", "product_name": "Efficib 50 mg/1000 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/461/001-002", "product_name": "Firazyr 30 mg solution for injection in pre-filled syringe", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2008-07-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B06AC", "B06AC02" ], "active_substances": [ "Icatibant" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/462/5,6,11,12", "product_name": "Ranexa 750 mg prolonged-release tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/463/004-008", "product_name": "Relistor", "holder": "Bausch Health Ireland Limited", "authorised_date": "2010-09-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A06AH", "A06AH01" ], "active_substances": [ "Methylnaltrexone bromide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/463/1-3", "product_name": "RELISTOR 12 mg/0.6 mL solution for injection", "holder": "Bausch Health Ireland Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A06AH", "A06AH01" ], "active_substances": [ "Methylnaltrexone bromide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/463/8-11", "product_name": "Relistor", "holder": "Bausch Health Ireland Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A06AH", "A06AH01" ], "active_substances": [ "Methylnaltrexone bromide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/465/1-14", "product_name": "Clopidogrel Zentiva 75 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/465/15-17", "product_name": "Clopidogrel Zentiva 300 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2008-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/466/1-2", "product_name": "Bridion 100 mg/ml solution for injection", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2008-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB", "V03AB35" ], "active_substances": [ "Sugammadex" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/468/002", "product_name": "Intelence 200 mg tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J05AG", "J05AG04" ], "active_substances": [ "Etravirine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/468/003", "product_name": "Intelence 25 mg tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J05AG", "J05AG04" ], "active_substances": [ "Etravirine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/468/1", "product_name": "Intelence 100 mg tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J05AG", "J05AG04" ], "active_substances": [ "Etravirine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/026-029", "product_name": "Oprymea 0.26 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/030-033", "product_name": "Oprymea 0.52 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/034-037", "product_name": "Oprymea 1.05 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/038-041", "product_name": "Oprymea 1.57 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/042-045", "product_name": "Oprymea 2.1 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/046-049", "product_name": "Oprymea 2.62 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole dihydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/050-053", "product_name": "Oprymea 3.15 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-02-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole dihydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/469/1-5", "product_name": "Oprymea 0.088 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2008-09-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/470/13", "product_name": "Vimpat 50mg/ 100mg/ 150mg film-coated tablets", "holder": "UCB Pharma S.A.", "authorised_date": "2008-08-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/470/14-15", "product_name": "Vimpat 15 mg/ml syrup", "holder": "UCB Pharma S.A.", "authorised_date": "2008-08-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/470/16", "product_name": "Vimpat 10 mg/ml solution for infusion", "holder": "UCB Pharma S.A.", "authorised_date": "2008-08-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], 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[ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/472/011-016", "product_name": "Xarelto 15 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/472/017-021", "product_name": "Xarelto 20 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2011-12-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/472/025-033", "product_name": "Xarelto 2.5 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2013-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New 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"active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/472/1-8", "product_name": "Xarelto 10 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2008-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/475/1-6", "product_name": "Olanzapine Mylan 2.5 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2008-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/475/13-17", "product_name": "Olanzapine Mylan 7 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/475/30-34", "product_name": "Olanzapine Mylan 20 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2008-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/475/7-12", "product_name": "Olanzapine Mylan 5 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2008-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/476/001-004", "product_name": "Adcirca (previously Tadalafil Lilly)", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2008-10-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/476/005-06", "product_name": "Adcirca 20 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-12-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/477/1", "product_name": "Ceplene 0.5 mg/0.5 ml solution for injection", "holder": "Laboratoires DELBERT", "authorised_date": "2008-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AX", "L03AX14" ], "active_substances": [ "Histamine dihydrochloride" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/479/001", "product_name": "ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection", "holder": "Cheplapharm Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine pamoate monohydrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product 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use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/480/13-18", "product_name": "Ifirmasta 300 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2008-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/480/7-12", "product_name": "Ifirmasta 150 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2008-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/481/004", "product_name": "Kuvan 100 mg powder for oral solution", "holder": "Biomarin International Limited", "authorised_date": "2017-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A16AX07" ], "active_substances": [ "Sapropterin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/481/005", "product_name": "Kuvan 500 mg powder for oral solution", "holder": "Biomarin International Limited", "authorised_date": "2017-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A16AX07" ], "active_substances": [ "Sapropterin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/481/1-3", "product_name": "Kuvan 100 mg soluble tablets", "holder": "Biomarin International Limited", "authorised_date": "2008-12-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "A16AX07" ], 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BH02" ], "active_substances": [ "Vildagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/488/001", "product_name": "Vidaza 25 mg/mL powder for suspension for injection", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2008-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC", "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC" ], "active_substances": [ "Pramipexole dihydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/492/001-006", "product_name": "RoActemra 20 mg/ml Concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2009-01-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC", "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/494/001", "product_name": "STELARA 45 mg Solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/494/003", "product_name": "STELARA 45 mg Solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/494/004", "product_name": "STELARA 90 mg Solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2010-03-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous 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"Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Ep2006 (recombinant human granulocyte-colony stimulating factor)" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/495/5-8,13-16", "product_name": "Zarzio 48 MU (96 MU/ml) Solution for injection or", "holder": "Sandoz GmbH", "authorised_date": "2009-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Ep2006 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"Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/496/5-8", "product_name": "Filgrastim Hexal 48 MU (96 MU/ml) Solution for injection or infusion", "holder": "Hexal AG", "authorised_date": "2009-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Ep2006 (recombinant human granulocyte-colony stimulating factor)" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/497/1,3", "product_name": "Nplate 250 micrograms", "holder": "Amgen Europe B.V.,", "authorised_date": "2010-01-11", "product_type": "HM", 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"Agomelatine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/501/1-2", "product_name": "Ixiaro 6 AU Suspension for injection", "holder": "Intercell Austria AG", "authorised_date": "2009-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07BA", "J07BA02" ], "active_substances": [ "Inactivated je virus" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/08/502/001", "product_name": "Mepact 4 mg Powder for concentrate for dispersion for 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"Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/508/007-009", "product_name": "Synflorix suspension for injection in vial", "holder": "GlaxoSmithKline Biologicals S.A.", "authorised_date": "2009-03-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07AL52" ], "active_substances": [ "Pneumococcal polysaccharide serotype 1", "Polysaccharide serotype 5", "Polysaccharide serotype 6b", "Polysaccharide serotype 9v", "Polysaccharide serotype 14", "Polysaccharide serotype 23f", "Polysaccharide serotype 4", "Polysaccharide serotype 19f" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active 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"N02AB03" ], "active_substances": [ "FENTANYL CITRATE" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/533/1-3", "product_name": "Vedrop 50 mg/ml Oral solution", "holder": "Recordati Rare Diseases", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A11HA08" ], "active_substances": [ "Tocofersolan d-alpha tocopheryl polyethylene glycol 1000 succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/535/1-16", "product_name": "Grepid 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be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/538/001", "product_name": "Afinitor 5 mg Tablet", "holder": "Novartis Europharm Limited", "authorised_date": "2009-09-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/538/004", "product_name": "Afinitor 10 mg Tablet", "holder": "Novartis Europharm Limited", "authorised_date": "2009-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/538/009-010", "product_name": "Afinitor 2.5 mg Tablet", "holder": "Novartis Europharm Limited", "authorised_date": "2013-03-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Rad n bht" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/539/005-006", "product_name": "Samsca 7.5 mg Tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2017-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03XA", "C03XA01" ], "active_substances": [ "Tolvaptan (opc-41061)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/539/1-2", "product_name": "Samsca 15 mg Tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2009-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03XA", "C03XA01" ], "active_substances": [ "Tolvaptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/539/3-4", "product_name": "Samsca 30 mg Tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2009-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03XA", "C03XA01" ], "active_substances": [ "Tolvaptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/540/1-16", "product_name": "Clopidogrel Teva 75 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2009-07-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel hydrogensulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/543/001", "product_name": "Cayston 75 mg powder and solvent for nebuliser solution.", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for nebuliser solution", "atc_codes": [ "J01DF01" ], "active_substances": [ "Aztreonam" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/544/1-2", "product_name": "Cimzia 200 mg solution for injection in pre-filled syringe", "holder": "UCB Pharma S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB05" ], "active_substances": [ "Certolizumab pegol" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/545/011-015", "product_name": "Onglyza 2.5 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "2011-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH", "A10BH03" ], "active_substances": [ "Saxaglitpin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/545/1-10", "product_name": "Onglyza 5 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "2009-10-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH", "A10BH03" ], "active_substances": [ "Saxagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/546/005-008", "product_name": "Simponi 100 mg solution for injection in pre-filled pen", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB", "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/546/009", "product_name": "Simponi 45 mg/0.45 mL solution for injection in pre-filled pen.", "holder": "Janssen-Cilag International NV", "authorised_date": "2019-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/546/1-4", "product_name": "Simponi 50 mg solution for injection in pre-filled pen", "holder": "Janssen-Cilag International NV", "authorised_date": "2009-10-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB", "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/550/1-12", "product_name": "Javlor 25 mg/mL concentrate for solution for infusion", "holder": "Pierre Fabre Medicament", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CA", "L01CA05" ], "active_substances": [ "Vinflunine ditartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/551/013-017", "product_name": "Vizarsin 25 mg orodispersible tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-05-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/551/018-022", "product_name": "Vizarsin 50 mg orodispersible tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-05-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/551/023-027", "product_name": "Vizarsin 100 mg orodispersible tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-05-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/551/1-4", "product_name": "Vizarsin 25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/551/5-8", "product_name": "Vizarsin 50 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/551/9-12", "product_name": "Vizarsin 100 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/552/003", "product_name": "ellaOne 30 mg film-coated tablet", "holder": "Laboratoire HRA Pharma", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AD", "G03AD02" ], "active_substances": [ "Ulipristal acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/553/001-10", "product_name": "Zyllt 75 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-09-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel hydrogensulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/555/1-9", "product_name": "Clopidogrel TAD 75 mg film-coated tablets", "holder": "TAD Pharma GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/556/1-9", "product_name": "Clopidogrel Krka 75 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/558/1-12", "product_name": "Clopidogrel BGR 75 mg film-coated tablets", "holder": "Laboratoires BIOGARAN", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/559/001-016", "product_name": "Clopidogrel Taw Pharma 75 mg film-coated tablets", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2009-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/562/001-9", "product_name": "Clopidogrel Krka d.d. 75 mg film-coated tablet", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/564/004", "product_name": "Ilaris 150 mg/ml solution for injection", "holder": "Novartis Europharm Limited", "authorised_date": "2017-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC", "L04AC08" ], "active_substances": [ "Canakinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/564/1-2", "product_name": "Ilaris 150 mg powder for solution for injection", "holder": "Novartis Europharm Limited", "authorised_date": "2009-10-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L04AC", "L04AC08" ], "active_substances": [ "Canakinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/565/1-2", "product_name": "Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe", "holder": "TEVA GmbH", "authorised_date": "2009-10-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B03XA", "B03XA01" ], 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"authorised_date": "2009-11-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BX", "A10BX02" ], "active_substances": [ "Repaglinide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/580/1-6", "product_name": "Enyglid 0.5 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BX", "A10BX02" ], "active_substances": [ "Repaglinide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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"HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AX", "A06AX05" ], "active_substances": [ "Prucalopride Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/583/1-24", "product_name": "Irbesartan/Hydrochlorothiazide Teva 150 mg/12.5 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-11-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA04" ], "active_substances": [ "Irbesartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"authorised_date": "2009-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/09/587/16-17", "product_name": "Olanzapine Glenmark 20 mg tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2009-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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2001/83/EC)" }, { "licence_number": "EU/1/10/621/13-18", "product_name": "Ristaben 100 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2010-03-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10B" ], "active_substances": [ "Sitagliptin as monohydrate phosphate salt" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/621/7-12", "product_name": "Ristaben 50 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2010-03-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10B" ], "active_substances": [ "Sitagliptin as monohydrate 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"TEPADINA 100 mg powder for concentrate for solution for infusion", "holder": "Adienne S.r.l.", "authorised_date": "2010-03-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AC", "L01AC01" ], "active_substances": [ "Thiotepa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/622/003", "product_name": "TEPADINA 400 mg powder and solvent for solution for infusion", "holder": "Adienne S.r.l. 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"Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/623/8-14", "product_name": "Clopidogrel/Acetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets", "holder": "Sanofi-Aventis Groupe", "authorised_date": "2010-03-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC30" ], "active_substances": [ "Acetylsalicylic acid", "Clopidogrel hydrogensulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/627/1-3", "product_name": "Raloxifene Teva 60 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2010-04-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03XC", "G03XC01" ], "active_substances": [ "Raloxifene hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/628/001-2", "product_name": "Votrient 200 mg Film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2010-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE11" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/628/003-4", "product_name": "Votrient 400 mg Film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2010-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE11" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/631/001-3", "product_name": "Nivestim 12 MU/0.2 ml solution for injection/infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2010-06-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/631/004-6", "product_name": "Nivestim 30 MU/0.2 ml solution for injection/infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2010-06-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/632/008-14", "product_name": "Tolura 40 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-06-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/632/015-21", "product_name": "Tolura 80 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-06-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/633/001-2", "product_name": "Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2010-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX17" ], "active_substances": [ "Topotecan (as hydrochloride)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/635/001", "product_name": "Olanzapine Apotex 2.5 mg film-coated tablets", "holder": "Apotex Europe B.V.", "authorised_date": "2010-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/635/002-3", "product_name": "Olanzapine Apotex 5 mg film-coated tablets", "holder": "Apotex Europe B.V.", "authorised_date": "2010-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/635/004-5", "product_name": "Olanzapine Apotex 7.5 mg film-coated tablets", "holder": "Apotex Europe B.V.", "authorised_date": "2010-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/636/001-007", "product_name": "Daxas 500 micrograms film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DX", "R03DX07" ], "active_substances": [ "Roflumilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/636/008", "product_name": "Daxas 250 micrograms tablets", "holder": "AstraZeneca AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R03DX", "R03DX07" 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"Leflunomide medac 20 mg film-coated tablets", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA13" ], "active_substances": [ "Leflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/637/010-012", "product_name": "Leflunomide medac 15 mg film-coated tablets", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA13" ], "active_substances": [ "Leflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/638/001", "product_name": "OZURDEX 700 micrograms intravitreal implant in applicator", "holder": "AbbVie Deutschland GmbH & Co. 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"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/639/011-020", "product_name": "Telmisartan Actavis 40 mg tablets", "holder": "Actavis Group hf", "authorised_date": "2010-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/639/021-030", "product_name": "Telmisartan Actavis 80 mg tablets", "holder": "Actavis Group hf", "authorised_date": "2010-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/640/001-003", "product_name": "Sycrest 5 mg sublingual tablets", "holder": "NV Organon", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N05AH", "N05AH05" ], "active_substances": [ "Asenapine maleate" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/640/004-006", "product_name": "Sycrest 10 mg sublingual tablets", "holder": "NV Organon", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N05AH", "N05AH05" ], "active_substances": [ "Asenapine maleate" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/641/001", "product_name": "Ruconest 2100 Units powder for solution for injection", "holder": "Pharming Group N.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "B06AC", "B06AC04" ], "active_substances": [ "Conestat alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/641/002", "product_name": "Ruconest 2100 Units powder and solvent for solution for injection", "holder": "Pharming Group N.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B06AC", "B06AC04" ], "active_substances": [ "Conestat alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/642/001-002", "product_name": "Ibandronic Acid Teva 50 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/642/003-004", "product_name": "Ibandronic Acid Teva 150 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/643/001", "product_name": "Rapiscan 400 microgram solution for injection", "holder": "GE Healthcare AS", "authorised_date": "2010-09-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01EB", "C01EB21" ], "active_substances": [ "Regadenoson" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/644/001-002", "product_name": "PecFent 100 micrograms/spray nasal spray, solution", "holder": "Grünenthal GmbH", "authorised_date": "2010-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl, as citrate salt" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/644/003-004", "product_name": "PecFent 400 micrograms/spray nasal spray, solution", "holder": "Grünenthal GmbH", "authorised_date": "2010-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl, as citrate salt" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/645/001-002", "product_name": "BRINAVESS 20 mg/ml concentrate for solution for infusion", "holder": "Correvio", "authorised_date": "2010-09-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01BG", "C01BG11" ], "active_substances": [ "Vernakalant hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/646/002-006", "product_name": "VPRIV 400 Units powder for solution for infusion", "holder": "Shire Pharmaceuticals Ireland Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "A16AB10" ], "active_substances": [ "Velaglucerase alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/647/001-002", "product_name": "Myclausen 500 mg film-coated tablets", "holder": "Herbert J. Passauer GmbH & Co. KG", "authorised_date": "2010-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/647/003-004", "product_name": "Myclausen 500 mg film-coated tablets", "holder": "Herbert J. Passauer GmbH & Co. KG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/648/001-007", "product_name": "Twynsta 40 mg/5 mg tablets", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2010-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DB", "C09DB04" ], "active_substances": [ "Telmisartan", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"Tablet", "atc_codes": [ "C09D" ], "active_substances": [ "Telmisartan", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/648/022-028", "product_name": "Twynsta 80 mg/10 mg tablets", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2010-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09D" ], "active_substances": [ "Telmisartan", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/652/001-003", "product_name": "Tobi Podhaler 28 mg inhalation powder, hard capsules", "holder": "Viatris Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "J01GB", "J01GB01" ], "active_substances": [ "Tobramycin" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/654/003-004", "product_name": "Leflunomide ratiopharm", "holder": "Ratiopharm GmbH", "authorised_date": "2010-11-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA13" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/655/012-014", "product_name": "Brilique 90 mg orodispersible tablets", "holder": "AstraZeneca AB", "authorised_date": "2017-05-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/657/001-002", "product_name": "Prepandemic Influenza", "holder": "GSK Vaccines S.r.l.", "authorised_date": "2010-11-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07BB", "J07BB02" ], "active_substances": [ "H5n1 (a/vietnam/1194/2004)" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/658/001-002", "product_name": "AFLUNOV suspension for injection in pre-filled syringe", "holder": "Seqirus S.r.l.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB", "J07BB02" ], "active_substances": [ "H5n1 (a/vietnam/1194/2004)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/659/001-002&8-10", "product_name": "Iasibon 50 mg film-coated tablets", "holder": "Pharmathen S.A.", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/659/003", "product_name": "Iasibon 1 mg concentrate for solution for infusion", "holder": "Pharmathen S.A.", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/659/004", "product_name": "Iasibon 2 mg concentrate for solution for infusion", "holder": "Pharmathen S.A.", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/659/005-007", "product_name": "Iasibon 6 mg concentrate for solution for infusion", "holder": "Pharmathen S.A.", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/660/001", "product_name": "Potactasol 1 mg powder for concentrate for solution for infusion", "holder": "Actavis Group hf", "authorised_date": "2011-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX17" ], "active_substances": [ "Topotecan hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/660/002", "product_name": "Potactasol 4 mg powder for concentrate for solution for infusion", "holder": "Actavis Group hf", "authorised_date": "2011-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX17" ], "active_substances": [ "Topotecan hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/10/665/001-004", "product_name": "Entacapone Teva 200 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BX", "N04BX02" ], "active_substances": [ "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/667/001-003", "product_name": "Esbriet 267 mg hard capsules", "holder": "H.A.C Pharma", "authorised_date": "2011-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/667/007-008", "product_name": "Esbriet 267 mg film-coated tablets", "holder": "H.A.C Pharma", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX", "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/667/009-010", "product_name": "Esbriet 534 mg film-coated tablets", "holder": "H.A.C Pharma", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX", "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/667/011", "product_name": "Esbriet 801 mg film-coated tablets", "holder": "H.A.C Pharma", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX", "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/667/012-017", "product_name": "Esbriet 267 mg film-coated tablets", "holder": "Roche Registration Limited", "authorised_date": "2017-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/667/018-019", "product_name": "Esbriet 801 mg film-coated tablets", "holder": "Roche Registration Limited", "authorised_date": "2017-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], 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"Teysuno 20 mg/5.8 mg/15.8 mg hard capsules", "holder": "Nordic Group B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01BC", "L01BC53" ], "active_substances": [ "Gimeracil", "Oteracil (as monopotassium salt)", "Tegafur" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/672/001", "product_name": "Xeplion 25 mg prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate 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"product_name": "Xeplion 75 mg prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/672/004", "product_name": "Xeplion 100 mg prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/672/005", "product_name": "Xeplion 150 mg prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/672/006", "product_name": "Xeplion 150 mg prolonged-release suspension for injection Xeplion 100 mg prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2019-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone", "Paliperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/673/001-008", "product_name": "Ifirmacombi 150 mg/12.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA04" ], "active_substances": [ "Hydrochlorothiazide", "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/673/009-016", "product_name": "Ifirmacombi 300 mg/12.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA04" ], "active_substances": [ "Hydrochlorothiazide", "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/673/017-024", "product_name": "Ifirmacombi 300 mg/25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA04" ], "active_substances": [ "Hydrochlorothiazide", "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/676/001", "product_name": "JEVTANA 60 mg concentrate and solvent for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2011-03-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate and solvent for 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"Gilenya 0.25 mg hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "FINGOLIMOD HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/678/001-002", "product_name": "HALAVEN 0.44 mg/ml solution for injection", "holder": "Eisai GmbH", "authorised_date": "2011-03-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX", "L01XX41" ], "active_substances": [ "Eribulin mesylate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription 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"HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB", "V03AB17" ], "active_substances": [ "Methylthioninium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/685/001-005", "product_name": "Ibandronic Acid Sandoz 50 mg film-coated tablets", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/691/016", "product_name": "Eliquis 0.15 mg granules in capsules for opening", "holder": "Bristol-Myers Squibb/Pfizer EEIG", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules in single-dose container", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/691/017", "product_name": "Eliquis 0.5 mg coated granule in sachet", "holder": "Bristol-Myers 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"EU/1/11/693/005-008", "product_name": "Rivastigmine Actavis 3 mg hard capsules", "holder": "Actavis Group hf", "authorised_date": "2011-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06DA", "N06DA03" ], "active_substances": [ "Rivastigmine hydrogen tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/693/009-012", "product_name": "Rivastigmine Actavis 4.5 mg hard capsules", "holder": "Actavis Group hf", "authorised_date": "2011-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06DA", "N06DA03" ], "active_substances": [ "Rivastigmine hydrogen tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/693/013-016", "product_name": "Rivastigmine Actavis 6 mg hard capsules", "holder": "Actavis Group hf", "authorised_date": "2011-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06DA", "N06DA03" ], "active_substances": [ "Rivastigmine hydrogen tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/694/001-002", "product_name": "NULOJIX 250 mg powder for concentrate for solution for infusion", "holder": "Bristol-Myers 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use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/696/005-006", "product_name": "Bydureon 2 mg prolonged-release suspension for injection in pre-filled pen", "holder": "AstraZeneca AB", "authorised_date": "2018-08-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection in pre-filled pen", "atc_codes": [ "A10BJ01" ], "active_substances": [ "Exenatide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/698/001-002", "product_name": "YERVOY 5 mg/ml concentrate for 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"GlaxoSmithKline (Ireland) Limited", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AA", "L04AA26" ], "active_substances": [ "Belimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/700/006-007", "product_name": "Benlysta 200 mg solution for injection in pre-filled syringe", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AA", "L04AA26" ], "active_substances": [ "Belimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/701/001-004", "product_name": "Levetiracetam Teva 250 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/701/008-014", "product_name": "Levetiracetam Teva 500 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/701/015-021", "product_name": "Levetiracetam Teva 750 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/701/022-028", "product_name": "Levetiracetam Teva 1000 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/702/001-003", "product_name": "Levetiracetam ratiopharm 100 mg/ml oral solution", "holder": "Ratiopharm GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/702/004-009", "product_name": "Levetiracetam ratiopharm 250 mg film-coated tablets", "holder": "Ratiopharm GmbH", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/702/010-017", "product_name": "Levetiracetam ratiopharm 500 mg film-coated tablets", "holder": "Ratiopharm GmbH", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/702/018-024", "product_name": "Levetiracetam ratiopharm 750 mg film-coated tablets", "holder": "Ratiopharm GmbH", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/702/025-031", "product_name": "Levetiracetam ratiopharm 1000 mg film-coated tablets", "holder": "Ratiopharm GmbH", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/703/001-002", "product_name": "XGEVA 120 mg solution for injection", "holder": "Amgen Europe B.V.,", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Entacapone", "Carbidopa monohydrate", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/707/001-011", "product_name": "Trajenta 5 mg film-coated tablets", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2011-08-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH", "A10BH05" ], "active_substances": [ "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active 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[ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/709/002", "product_name": "BUCCOLAM 5 mg oromucosal solution", "holder": "Laboratorios Lesvi, S.L.", "authorised_date": "2011-10-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD", "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/709/003", "product_name": "BUCCOLAM 7.5 mg oromucosal solution", "holder": "Laboratorios 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"authorised_date": "2013-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Rad n bht" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/710/012-013", "product_name": "Votubia 3 mg Dispersible tablet", "holder": "Novartis Europharm Limited", "authorised_date": "2013-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Rad n bht" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/710/014-015", "product_name": "Votubia 5 mg Dispersible tablet", "holder": "Novartis Europharm Limited", "authorised_date": "2013-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Rad n bht" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/710/016", "product_name": "Votubia 1mg Dispersible tablet", "holder": "Novartis Europharm Limited", "authorised_date": "2018-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "L01XE", "L01XE10" ], 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"authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/711/015-022", "product_name": "Matever 750 mg film-coated tablets", "holder": "Pharmathen S.A.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/711/023-029", "product_name": "Matever 1000 mg film-coated tablets", "holder": "Pharmathen S.A.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/711/030", "product_name": "Matever 100 mg/ml concentrate for solution for infusion", "holder": "Pharmathen S.A.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/712/001-007", "product_name": "Levetiracetam Accord 250 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/712/008-013", "product_name": "Levetiracetam Accord 500 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/712/015-021", "product_name": "Levetiracetam Accord 750 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/713/011-020", "product_name": "Levetiracetam Actavis 500 mg film-coated tablets", "holder": "Actavis Group hf", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) 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"Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/714/001", "product_name": "ZYTIGA 250 mg tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2011-09-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02BX", "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/714/002-003", "product_name": "ZYTIGA 500 mg tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX", "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/715/001", "product_name": "Plenadren 5 mg modified-release tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/715/002", "product_name": "Plenadren 20 mg modified-release tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/716/001-004", "product_name": "Eurartesim 320 mg/40 mg film-coated tablets", "holder": "Alfasigma S.p.A", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", 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"holder": "Orion Corporation", "authorised_date": "2011-09-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N05CM", "N05CM18" ], "active_substances": [ "Dexmedetomidine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/719/001-020", "product_name": "Telmisartan Teva Pharma 20 mg tablets", "holder": "Teva B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/719/021-040", "product_name": "Telmisartan Teva Pharma 40 mg tablets", "holder": "Teva B.V.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/719/041-060", "product_name": "Telmisartan Teva Pharma 80 mg tablets", "holder": "Teva B.V.", "authorised_date": "2011-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", 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"Ratiopharm GmbH", "authorised_date": "2012-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX27" ], "active_substances": [ "Desloratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/11/747/001", "product_name": "Colobreathe 1,662,500 IU inhalation powder, hard capsules", "holder": "Essential Pharma Limited", "authorised_date": "2012-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "J01XB01" ], "active_substances": [ "Colistimethate sodium" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], 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"dosage_form": "Powder and gel for gel", "atc_codes": [ "D03BA03" ], "active_substances": [ "Partially purified bromelain" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/803/002", "product_name": "NexoBrid 5 g powder and gel for gel", "holder": "MediWound Germany GmbH", "authorised_date": "2013-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and gel for gel", "atc_codes": [ "D03BA03" ], "active_substances": [ "Partially purified bromelain" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/805/001-002", "product_name": "Amyvid 800 MBq/mL solution for injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2013-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AX", "V09AX05" ], "active_substances": [ "Florbetapir (18f)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/805/003-004", "product_name": "Amyvid 1,900 MBq/mL solution for injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AX", "V09AX05" ], "active_substances": [ "Florbetapir (18f)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/806/1,4,5,7,8", "product_name": "Ryzodeg 100 units/mL solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AD", "A10AD06" ], "active_substances": [ "Insulin degludec (ideg)", "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/807/1,4,5,7,8", "product_name": "Tresiba 100 units/mL solution for injection in 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"dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/808/001-012", "product_name": "Imatinib Teva 100 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE01" ], "active_substances": [ "Imatinib mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/808/013-020", "product_name": "Imatinib Teva 400 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-01-17", "product_type": 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"licence_number": "EU/1/12/808/033-040", "product_name": "Imatinib Teva 400 mg hard capsules", "holder": "Teva Pharma B.V.", "authorised_date": "2013-01-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [], "active_substances": [ "Imatinib mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/809/001-007", "product_name": "Betmiga 25 mg prolonged-release tablets", "holder": "Astellas Pharma Europe BV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD", "G04BD12" ], "active_substances": [ "Mirabegron (ym178)" ], "routes": [ "Oral use" ], "dispensing_status": [ 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"2024-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules for oral suspension", "atc_codes": [ "G04BD12" ], "active_substances": [ "Mirabegron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/12/812/001-004", "product_name": "Bexsero 0.5 ml suspension for injection in pre-filled syringe", "holder": "Glaxosmithkline Vaccines S.r.l.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AH09" ], "active_substances": [ "Recombinant neisseria meningitidis serogroup b nhba fusion protein", "Recombinant neisseria meningitidis serogroup b nada fusion protein", 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"dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX", "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/824/011-013", "product_name": "Nemdatine 15 mg film-coated tablets", "holder": "Actavis Group hf", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX", "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/824/014-017", "product_name": "Nemdatine 20 mg film-coated tablets", "holder": "Actavis Group hf", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX", "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/824/018", "product_name": "Nemdatine 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets", "holder": "Actavis Group hf", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX", "N06DX01" ], "active_substances": [ "Memantine hydrochloride", "Memantine hydrochloride", "Memantine 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through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/854/001-005", "product_name": "Inflectra 100 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2013-09-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AB", "L04AB02" ], "active_substances": [ "Ct-p13 (infliximab)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/855/001", "product_name": "IMVANEX suspension for injection", "holder": "Bavarian Nordic A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07BX" ], "active_substances": [ "Mva-bn virus" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/856/001-002", "product_name": "Lonquex 6 mg solution for injection in pre-filled syringe", "holder": "Teva B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA14" ], "active_substances": [ "Xm22 drug substance lipegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/856/004", "product_name": "Lonquex 6 mg/0.6 ml solution for injection", "holder": "Teva B.V.", "authorised_date": "2023-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AA14" ], "active_substances": [ "lipegfilgrastim" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/856/005", "product_name": "Lonquex 6 mg/0.6 ml solution for injection", "holder": "Teva B.V.", "authorised_date": "2023-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AA14" ], "active_substances": [ "lipegfilgrastim" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/857/001", "product_name": "Voncento 250 IU/600 IU Powder and solvent for solution for injection/infusion", "holder": "CSL Behring GmbH", "authorised_date": "2013-08-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B02BD", "B02BD06" ], "active_substances": [ "Human coagulation factor viii", "Von willebrand factor" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/857/002", "product_name": "Voncento 500 IU/1200 IU Powder and solvent for solution for injection/infusion", "holder": "CSL Behring GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B02BD", "B02BD06" ], "active_substances": [ "Von willebrand factor", "Human coagulation factor viii" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/857/003", "product_name": "Voncento 500 IU/1200 IU Powder and solvent for solution for injection/infusion", "holder": "CSL Behring GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for 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"Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/858/001-002", "product_name": "Stivarga 40 mg film-coated tablets", "holder": "Bayer Pharma AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE21" ], "active_substances": [ "Regorafenib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/001-006", "product_name": "Corbilta 50 mg/12.5 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Carbidopa monohydrate", "Entacapone", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/007-011", "product_name": "Corbilta 75 mg/18.75 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "2013-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Entacapone", "Carbidopa monohydrate", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/012-017", "product_name": "Corbilta 100 mg/25mg/200 mg film coated tablets", "holder": "Orion Corporation", "authorised_date": "2013-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Carbidopa monohydrate", "Entacapone", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/018-022", "product_name": "Corbilta 125 mg/31.25 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "2013-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Entacapone", "Carbidopa monohydrate", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/023-028", "product_name": "Corbilta 150 mg/37.5 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "2013-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa monohydrate", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/029-033", "product_name": "Corbilta 175 mg/43.75 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "2013-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Entacapone", "Carbidopa monohydrate", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/859/034-038", "product_name": "Corbilta 200 mg/50 mg/200 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "2013-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Entacapone", "Carbidopa monohydrate", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/860/001-002", "product_name": "Nexium Control 20 mg gastro-resistant tablets", "holder": "GlaxoSmithKline Dungarvan Limited", "authorised_date": "2013-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/860/003", "product_name": "Nexium Control 20 mg gastro-resistant hard capsules", "holder": "GlaxoSmithKline Dungarvan Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/861/001", "product_name": "PROCYSBI 25 mg gastro-resistant hard capsules", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A16AA", "A16AA04" ], "active_substances": [ "Cysteamine bitartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/861/002", "product_name": "PROCYSBI 75 mg gastro-resistant hard capsules", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A16AA", "A16AA04" ], "active_substances": [ "Cysteamine bitartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/861/003", "product_name": "PROCYSBI 75 mg gastro-resistant granules", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2013-09-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant granules", "atc_codes": [ "A16AA04" ], "active_substances": [ "Mercaptamine bitartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/861/004", "product_name": "PROCYSBI 300 mg gastro-resistant granules", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2013-09-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant granules", "atc_codes": [ "A16AA04" ], "active_substances": [ "Mercaptamine bitartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/862/001-006", "product_name": "Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2013-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AL", "R03AL04" ], "active_substances": [ "Indacaterol maleate", "Glycopyrronium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/863/001-006", "product_name": "Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA", "C10BA04" ], "active_substances": [ "Micronized fenofibrate", "Simvastatin with 0.2% butylated hydroxyanisole (bha), (E320)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/866/003-004", "product_name": "Cholib 145 mg/40 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2013-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA", "C10BA04" ], "active_substances": [ "Micronized fenofibrate", "Simvastatin with 0.2% butylated hydroxyanisole (bha), (E320)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA", "A05AA03" ], "active_substances": [ "Cholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/870/004-006", "product_name": "Orphacol 250 mg hard capsules", "holder": "Theravia", "authorised_date": "2013-09-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA", "A05AA03" ], "active_substances": [ "Cholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/871/001-003", "product_name": "Ovaleap 300 IU/0.5 mL solution for injection", "holder": "Theramex Ireland Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/872/001-002", "product_name": "Tybost 150 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AX", "V03AX03" ], "active_substances": [ "Cobicistat on silicon 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"2014-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J04AK", "J04AK06" ], "active_substances": [ "Delamanid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/875/005", "product_name": "Deltyba 25 mg dispersible tablets", "holder": "Otsuka Novel Products GmbH", "authorised_date": "2021-09-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "J04AK06" ], "active_substances": [ "Delamanid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application 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"active_substances": [ "Afatinib-dimaleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/879/007-009", "product_name": "GIOTRIF 40 mg film-coated tablets", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE13" ], "active_substances": [ "Afatinib-dimaleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/879/010-012", "product_name": "GIOTRIF 50 mg film-coated 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"Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/882/001,003", "product_name": "Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/882/002,004", "product_name": "Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2014-01-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/882/009", "product_name": "Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled 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"N05AX12" ], "active_substances": [ "Aripiprazole Monohydrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/884/001-004", "product_name": "Invokana 100 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK", "A10BK02" ], "active_substances": [ "Canagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/884/005-008", "product_name": "Invokana 300 mg 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"Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/885/002", "product_name": "Kadcyla 160 mg powder for concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD03" ], "active_substances": [ "Trastuzumab emtansine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/886/001-003", "product_name": "Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK10" ], "active_substances": [ "Fluticasone furoate", "Vilanterol trifenatate micronised" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/886/004-006", "product_name": "Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK10" ], "active_substances": [ "Fluticasone furoate", "Vilanterol trifenatate micronised" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/888/001", "product_name": "NovoEight 250 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Turoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/888/002", "product_name": "NovoEight 500 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Turoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/888/003", "product_name": "NovoEight 1000 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Turoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/888/004", "product_name": "NovoEight 1500 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Turoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/888/005", "product_name": "NovoEight 2000 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Turoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/888/006", "product_name": "NovoEight 3000 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2013-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Turoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/889/001-002", "product_name": "Levetiracetam Hospira 100 mg/ml concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2014-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/890/001", "product_name": "COMETRIQ 20 mg hard 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"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/892/003-004", "product_name": "Tivicay 10 mg film-coated tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2017-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX", "J05AX12" ], "active_substances": [ "Dolutegravir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/892/005-006", "product_name": "Tivicay 25 mg film-coated tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2017-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX", "J05AX12" ], 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"Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/894/001-002", "product_name": "Sovaldi 400 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX", "J05AX15" ], "active_substances": [ "Sofosbuvir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/894/003", "product_name": "Sovaldi 200 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AP08" ], "active_substances": [ "Sofosbuvir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/894/004", "product_name": "Sovaldi 150 mg coated granules in sachet", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "J05AP08" ], "active_substances": [ "Sofosbuvir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/894/005", "product_name": "Sovaldi 200 mg coated granules in sachet", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "J05AP08" ], "active_substances": [ "Sofosbuvir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/900/001-006", "product_name": "Xigduo 5 mg/850 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD15" ], "active_substances": [ "Dapagliflozin propanediol monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"dosage_form": "Tablet", "atc_codes": [ "J04AK", "J04AK05" ], "active_substances": [ "Bedaquiline fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/901/003", "product_name": "SIRTURO 20 mg tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J04AK05" ], "active_substances": [ "Bedaquiline fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/902/001", "product_name": "Translarna", "holder": "PTC Therapeutics International Limited", "authorised_date": "2014-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "M09AX", "M09AX03" ], "active_substances": [ "Ataluren" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/902/002", "product_name": "Translarna", "holder": "PTC Therapeutics International Limited", "authorised_date": "2014-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "M09AX", "M09AX03" ], "active_substances": [ "Ataluren" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"dosage_form": "Eye drops, solution", "atc_codes": [ "S01EE", "S01EE04" ], "active_substances": [ "Travoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/906/001", "product_name": "Neuraceq 300 MBq/mL solution for injection", "holder": "Life Molecular Imaging GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AX", "V09AX06" ], "active_substances": [ "Florbetaben" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/907/001-003", "product_name": "Adempas 0.5 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX05" ], "active_substances": [ "Riociguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/907/004-006", "product_name": "Adempas 1 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2014-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX05" ], "active_substances": [ "Riociguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/907/007-009", "product_name": "Adempas 1.5 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2014-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX05" ], "active_substances": [ "Riociguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/907/010-012", "product_name": "Adempas 2 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2014-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX05" ], "active_substances": [ "Riociguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/907/013-015", "product_name": "Adempas 2.5 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2014-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX05" ], "active_substances": [ "Riociguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/13/907/021", "product_name": "Adempas 0.15 mg/mL granules for oral 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"dosage_form": "Prolonged-release tablet", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/35/007-009", "product_name": "Envarsus 4 mg prolonged-release tablets", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2014-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/898/001-003", "product_name": "ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2014-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AL03" ], "active_substances": [ "Vilanterol trifenatate", "Umeclidinium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/899/001-003", "product_name": "LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2014-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AL03" ], "active_substances": [ "Umeclidinium bromide", "Vilanterol trifenatate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/913/001-007", "product_name": "Latuda 18.5 mg film-coated tablets", "holder": "Aziende Chimiche Riunite Angelini Francesco", "authorised_date": "2014-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AE", "N05AE05" ], "active_substances": [ "Lurasidone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/913/008-014", "product_name": "Latuda 37 mg film-coated tablets", "holder": "Aziende Chimiche Riunite Angelini Francesco", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AE", "N05AE05" ], "active_substances": [ "Lurasidone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/913/015-021", "product_name": "Latuda 74 mg film-coated tablets", "holder": "Aziende Chimiche Riunite Angelini Francesco", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", 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"Vokanamet 150 mg/850 mg Film-coated tablet", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [ "MICROCRYSTALLINE CELLULOSE", "Croscarmellose sodium", "Canagliflozin", "Purified water", "Metformin Hydrochloride", "Hypromellose 2910, 15 mpa.s" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/918/010-012", "product_name": "Vokanamet 150 mg/1000 mg Film-coated tablet", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [ "Purified 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"EU/1/14/921/004-006", "product_name": "BiResp Spiromax 320 micrograms/9 micrograms inhalation powder", "holder": "Teva Pharma B.V.", "authorised_date": "2014-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/922/001-003", "product_name": "Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2014-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03BB07" 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"Entyvio 108 mg solution for injection in pre-filled syringe", "holder": "Takeda Pharma A/S", "authorised_date": "2020-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AA33" ], "active_substances": [ "Vedolizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/923/005-007", "product_name": "Entyvio 108 mg solution for injection in pre-filled pen", "holder": "Takeda Pharma A/S", "authorised_date": "2020-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AA33" ], "active_substances": [ "Vedolizumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/928/001", "product_name": "SYLVANT 100 mg powder for concentrate for solution for infusion", "holder": "EUSA Pharma (Netherlands) B.V.", "authorised_date": "2014-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AC", "L04AC11" ], "active_substances": [ "Siltuximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/928/002", "product_name": "SYLVANT 400 mg powder for concentrate for solution 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"Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/931/01-02", "product_name": "Mekinist 0.5 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2014-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EE01" ], "active_substances": [ "Trametinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/931/03-04", "product_name": "Mekinist 1 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2014-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE25" ], "active_substances": [ "Trametinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/931/05-06", "product_name": "Mekinist 2 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2014-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EE01" ], "active_substances": [ "Trametinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { 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"active_substances": [ "Peginterferon beta-1a" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/934/002", "product_name": "Plegridy", "holder": "Biogen Netherlands B.V.", "authorised_date": "2014-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L03AB13" ], "active_substances": [ "Peginterferon beta-1a" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/934/003-004", "product_name": "Plegridy 125 micrograms 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], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/001", "product_name": "Nuwiq 250 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/002", "product_name": "Nuwiq 500 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2014-07-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/003", "product_name": "Nuwiq 1000 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2014-07-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/004", "product_name": "Nuwiq 2000 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/005", "product_name": "Nuwiq 2500 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/006", "product_name": "Nuwiq 3000 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/007", "product_name": "Nuwiq 4000 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/936/008", "product_name": "Nuwiq 1500 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2022-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/937/001", "product_name": "Gazyvaro 1,000 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC15" ], "active_substances": [ "Obinutuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/938/001", "product_name": "Zydelig 100 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2014-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX47" ], "active_substances": [ "Idelalisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/938/002", "product_name": "Zydelig 150 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2014-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX47" ], "active_substances": [ "Idelalisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/940/001-002", "product_name": "Triumeq 50 mg/600 mg/300 mg film-coated tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2014-09-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR13" ], "active_substances": [ "Dolutegravir", "Abacavir", "Lamivudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/940/001-003", "product_name": "Triumeq 5 mg/60 mg/30 mg dispersible tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2023-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "J05AR13" ], "active_substances": [ "Dolutegravir sodium", "Lamivudine", "Abacavir sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/941/001-002", "product_name": "VIZAMYL 400 MBq/mL solution for injection", "holder": "GE Healthcare AS", "authorised_date": "2014-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AX" ], "active_substances": [ "Flutemetamol (18F)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/943/001-004", "product_name": "Velphoro 500 mg chewable tablets", "holder": "Vifor Fresenuis Medical Care Renal Pharma France", "authorised_date": "2014-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "V03AE", "V03AE05" ], "active_substances": [ "Mixture of iron(iii)-oxyhydroxide, sucrose, starches" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/943/003-004", "product_name": "Accofil 48 MU/0.5 ml solution for injection/infusion in pre-filled syringe", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2014-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/943/005", "product_name": "Velphoro 125 mg oral powder in sachet", "holder": "Vifor Fresenius Medical Care Renal Pharma France", "authorised_date": "2020-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in sachet", "atc_codes": [ "V03AE05" ], "active_substances": [ "Sucroferric Oxyhydroxide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/944/001-004", "product_name": "ABASAGLAR 100 units/mL solution for injection in a cartridge", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2014-09-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/944/005-008", "product_name": "ABASAGLAR 100 units/mL solution for injection in a pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2014-09-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/945/001-002", "product_name": "IMBRUVICA 140 mg hard capsules", "holder": "Janssen-Cilag International NV", "authorised_date": "2014-10-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE27" ], "active_substances": [ "Ibrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/945/005", "product_name": "IMBRUVICA 420 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE27" ], "active_substances": [ "Ibrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/945/006", "product_name": "IMBRUVICA 560 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE27" ], "active_substances": [ "Ibrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/945/007-008", "product_name": "IMBRUVICA 140 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE27" ], "active_substances": [ "Ibrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/945/009-010", "product_name": "IMBRUVICA 280 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE27" ], "active_substances": [ "Ibrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/946/001-002", "product_name": "Accofil 30 MU/0.5 ml solution for injection/infusion in pre-filled syringe", "holder": "Accord Healthcare S.L.U.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/947/001-004", "product_name": "Xultophy 100 units/mL + 3.6 mg/mL solution for injection.", "holder": "Novo Nordisk A/S", "authorised_date": "2014-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10" ], "active_substances": [ "Insulin degludec", "Liraglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/951/001", "product_name": "Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01AB", "L01AB01" ], "active_substances": [ "Busulfan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/952/001", "product_name": "Sevelamer carbonate Winthrop 800 mg film-coated tablets", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2015-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE", "V03AE02" ], "active_substances": [ "Sevelamer carbonate", "Sevelamer carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/952/002-003", "product_name": "Sevelamer carbonate Winthrop 2.4 g powder for oral suspension", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2015-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "V03AE", "V03AE02" ], "active_substances": [ "Sevelamer carbonate" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/952/005-006", "product_name": "Sevelamer carbonate Winthrop 0.8 g powder for oral suspension", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "V03AE02" ], "active_substances": [ "Sevelamer carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/953/001", "product_name": "Sevelamer Hydrochloride Zentiva", "holder": "Sanofi B.V.", "authorised_date": "2015-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE", "V03AE02" ], "active_substances": [ "Sevelamer hydrochloride" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/954/001-003", "product_name": "Vargatef 100 mg soft capsules", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2014-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01XE", "L01XE31" ], "active_substances": [ "Nintedanib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/954/004", "product_name": "Vargatef 150 mg soft capsules", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2014-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01XE", "L01XE31" ], "active_substances": [ "Nintedanib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/956/001-005", "product_name": "Trulicity 0.75 mg Solution for injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10BX" ], "active_substances": [ "Dulaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 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"active_substances": [ "Dulaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/956/014-0016", "product_name": "Trulicity 4.5 mg Solution for injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2014-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10B" ], "active_substances": [ "Dulaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/957/001-003", "product_name": "Cyramza 10 mg/ml 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "J05AP51" ], "active_substances": [ "Ledipasvir", "Sofosbuvir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/958/005", "product_name": "Harvoni 45 mg/200 mg Coated granules", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2020-07-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "J05AP51" ], "active_substances": [ "Ledipasvir", "Sofosbuvir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/959/002-003", "product_name": "Lynparza 100 mg Film-coated tablet", "holder": "AstraZeneca AB", "authorised_date": "2018-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX46" ], "active_substances": [ "Olaparib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/959/004-005", "product_name": "Lynparza 150 mg Film-coated tablet", "holder": "AstraZeneca AB", "authorised_date": "2018-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX46" ], "active_substances": [ "Olaparib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/960/001", "product_name": "DUAVIVE 0.45 mg/20 mg modified-release tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2014-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "G03CX" ], "active_substances": [ "Conjugated estrogens (ce)", "Bazedoxifene acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/961/001", "product_name": "Tadalafil Mylan 10 mg film-coated tablets", "holder": "Mylan 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"supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/961/008-009", "product_name": "Tadalafil Mylan 2.5 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2014-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/961/012-017", "product_name": "Tadalafil Mylan 5 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2014-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/962/001-003", "product_name": "Moventig 12.5 mg film-coated tablets", "holder": "Grünenthal GmbH", "authorised_date": "2014-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AH03" ], "active_substances": [ "Naloxegol oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/962/004-007", "product_name": "Moventig 25 mg film-coated tablets", "holder": "Grünenthal GmbH", "authorised_date": "2014-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AH03" ], "active_substances": [ "Naloxegol oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/963/001-003", "product_name": "Brimica Genuair 340 micrograms /12 micrograms inhalation powder", "holder": "Covis Pharma Europe B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AL", "R03AL05" ], "active_substances": [ "Micronized formoterol fumarate dihydrate", 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"licence_number": "EU/1/14/965/001", "product_name": "Ketoconazole Esteve 200 mg tablets", "holder": "Esteve Pharmaceuticals S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J02AB", "J02AB02" ], "active_substances": [ "Ketoconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/967/001", "product_name": "REZOLSTA 800 mg/150 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2014-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR14" ], "active_substances": [ "Darunavir", "Cobicistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/967/002", "product_name": "REZOLSTA 675 mg/150 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR14" ], "active_substances": [ "Darunavir ethanolate", "Cobicistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/967/003", "product_name": "REZOLSTA 600 mg/90 mg dispersible tablets", "holder": "Janssen-Cilag 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"registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD04" ], "active_substances": [ "Nonacog gamma" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/970/003", "product_name": "RIXUBIS 1000 IU powder and solvent for solution for injection", "holder": "Baxter Innovations GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD04" ], "active_substances": [ "Nonacog gamma" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/970/004", "product_name": "RIXUBIS 2000 IU powder and solvent for solution for injection", "holder": "Baxter Innovations GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD04" ], "active_substances": [ "Nonacog gamma" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/970/005", "product_name": "RIXUBIS 3000 IU powder and solvent for solution for injection", "holder": "Baxter Innovations GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD04" ], "active_substances": [ "Nonacog gamma" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/971/007", "product_name": "Trevicta 175mg Prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/971/008", "product_name": "Trevicta 263mg Prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/971/009", "product_name": "Trevicta 350mg Prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/971/010", "product_name": "Trevicta 525mg Prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX13" ], "active_substances": [ "Paliperidone palmitate (r092670)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to 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"authorised_date": "2015-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC10" ], "active_substances": [ "Secukinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/980/012-013", "product_name": "Cosentyx 75 mg Solution for injection pre-filled syringe", "holder": "Novartis Europharm Limited", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC10" ], "active_substances": [ "Secukinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/980/10-011", "product_name": "Cosentyx 300 mg Solution for injection in pre-filled pen", "holder": "Novartis Europharm Limited", "authorised_date": "2020-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC10" ], "active_substances": [ "Secukinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/981/001", "product_name": "Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets", "holder": "Amgen Europe B.V.,", 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"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/981/004", "product_name": "Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets", "holder": "Amgen Europe B.V.,", "authorised_date": "2015-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/14/981/005", "product_name": "Otezla 20 mg film–coated tablets", "holder": "Amgen Europe B.V.,", "authorised_date": "2015-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", 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"Helsinn Birex Pharmaceuticals Limited", "authorised_date": "2015-05-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A04AA", "A04AA05" ], "active_substances": [ "Netupitant", "Palonosetron (as hydrochloride)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1001/003", "product_name": "Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion", "holder": "Helsinn Birex Pharmaceuticals Limited", "authorised_date": "2015-05-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "A04AA55" ], "active_substances": [ "FOSNETUPITANT CHLORIDE HYDROCHLORIDE", 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"licence_number": "EU/1/15/1002/001", "product_name": "LENVIMA 4 mg hard capsules", "holder": "Eisai GmbH", "authorised_date": "2015-05-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01X" ], "active_substances": [ "Lenvatinib mesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1002/002", "product_name": "LENVIMA 10 mg hard capsules", "holder": "Eisai GmbH", "authorised_date": "2015-05-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01X" ], "active_substances": [ "Lenvatinib mesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"Pregabalin Sandoz 25 mg hard capsules", "holder": "Sandoz GmbH", "authorised_date": "2015-06-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03A" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1011/011-017", "product_name": "Pregabalin Sandoz 50 mg hard capsules", "holder": "Sandoz GmbH", "authorised_date": "2015-06-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03A" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1029/043-047", "product_name": "Aripiprazole Sandoz 20 mg Tablets", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1029/048-061", "product_name": 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1031/001-003", "product_name": "Praluent 75 mg solution for injection in pre-filled pen", "holder": "Sanofi-Aventis Groupe", "authorised_date": "2015-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C10AX", "C10AX14" ], "active_substances": [ "Alirocumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1031/004-006", "product_name": "Praluent 75 mg solution for injection in pre-filled syringe", "holder": "Sanofi-Aventis Groupe", "authorised_date": "2015-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C10AX", "C10AX14" ], "active_substances": [ "Alirocumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1031/007-009", "product_name": "Praluent 150 mg solution for injection in pre-filled pen", "holder": "Sanofi-Aventis Groupe", "authorised_date": "2015-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C10AX", "C10AX14" ], "active_substances": [ "Alirocumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C10AX14" ], "active_substances": [ "Alirocumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1032/001", "product_name": "Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2015-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01DI", "J01DI54" ], "active_substances": [ "Ceftolozane sulfate", "Tazobactam sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD14" ], "active_substances": [ "Susoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1036/001", "product_name": "CRESEMBA 200 mg powder for concentrate for solution for infusion", "holder": "Basilea Pharmaceutica Deutschland GmbH", "authorised_date": "2015-10-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AC", "J02AC05" ], "active_substances": [ "Isavuconazonium sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1036/002", "product_name": "CRESEMBA 100 mg hard capsules", "holder": "Basilea Pharmaceutica Deutschland GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AC", "J02AC05" ], "active_substances": [ "Isavuconazonium sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1036/003", "product_name": "CRESEMBA 40 mg hard capsules", "holder": "Basilea Pharmaceutica Deutschland GmbH", "authorised_date": "2024-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC05" ], "active_substances": [ "Isavuconazonium sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1038/001", "product_name": "Pemetrexed medac 100 mg powder for concentrate for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2015-11-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1040/001-002", "product_name": "Intuniv 1 mg prolonged-release tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC", "C02AC02" ], "active_substances": [ "GUANFACINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1040/003-005", "product_name": "Intuniv 2 mg prolonged-release tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "", "product_type": "HM", 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1041/008-014", "product_name": "Ivabradine Anpharm 7.5 mg film-coated tablets", "holder": "Anpharm Przedsiebiorstwo Farmaceutyczne S.A", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent 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"dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "R03DX09" ], "active_substances": [ "Mepolizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1043/005-006", "product_name": "Nucala 100 mg solution for injection in pre-filled syringe", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2015-12-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "R03DX09" ], "active_substances": [ "Mepolizumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) 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"Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1048/001", "product_name": "Cotellic 20 mg film-coated tablets", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EE02" ], "active_substances": [ "Cobimetinib hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1049/001-002", "product_name": "Cystadrops 3.8 mg/mL eye drops solution", "holder": "Recordati Rare Diseases", "authorised_date": "2017-01-19", "product_type": "HM", 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"legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1051/007-012", "product_name": "Ebymect 5 mg/1,000 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "2015-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD15" ], "active_substances": [ "Metformin Hydrochloride", "Dapagliflozin propanediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1052/001-005", "product_name": "Edistride 5 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BX", "A10BX09" ], "active_substances": [ "Dapagliflozin propanediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1052/006-010", "product_name": "Edistride 10 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "2015-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BX", "A10BX09" ], "active_substances": [ "Dapagliflozin propanediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1053/001", "product_name": "Neofordex 40 mg tablets", "holder": "Laboratoires CTRS", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1054/001-004", "product_name": "Cinacalcet Mylan 30 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05BX", "H05BX01" ], "active_substances": [ "Cinacalcet hydrochloride" ], "routes": [ "Oral 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AB" ], "active_substances": [ "Idarucizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1057/001", "product_name": "Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2015-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01B" ], "active_substances": [ "Pemetrexed disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1057/002", "product_name": "Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2015-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01B" ], "active_substances": [ "Pemetrexed disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1057/003", "product_name": "Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2015-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01B" ], "active_substances": [ "Pemetrexed disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1057/004-006", "product_name": "Pemetrexed Pfizer 25 mg/ml concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA04" ], "active_substances": [ "Pemetrexed Disodium Hemipentahydrate", "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1058/001", "product_name": "Entresto 24 mg/26 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX04" ], "active_substances": [ "Sacubitril valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1058/002-004", "product_name": "Entresto 49 mg/51 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX04" ], "active_substances": [ "Sacubitril valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1058/005-007", "product_name": "Entresto 97 mg/103 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX04" ], "active_substances": [ "Sacubitril valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1058/023", "product_name": "Entresto 6 mg/6 mg granules in capsules for opening", "holder": "Novartis Europharm Limited", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1059/001", "product_name": "Orkambi 200 mg/125 mg film-coated tablets", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX", "R07AX30" ], "active_substances": [ "Lumacaftor", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1059/005", "product_name": "Orkambi 100 mg/125 mg film-coated tablets", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2018-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX", "R07AX30" ], "active_substances": [ "Lumacaftor", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1059/006", "product_name": "Orkambi 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"Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1059/008", "product_name": "Orkambi 75 mg/94 mg granules in sachet", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "R07AX30" ], "active_substances": [ "Lumacaftor", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1060/001", "product_name": "Kyprolis 60 mg powder for solution for infusion", "holder": "Amgen Europe B.V.,", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX", "L01XX45" ], "active_substances": [ "Carfilzomib" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1061/001-002", "product_name": "Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR18" ], "active_substances": [ "Elvitegravir", "Cobicistat", "Emtricitabine", "Tenofovir alafenamide fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not 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"authorised_date": "2015-11-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral liquid", "atc_codes": [ "A16AX09" ], "active_substances": [ "Glycerol phenylbutyrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1063/001-004", "product_name": "Armisarte 25 mg/ml concentrate for solution for infusion", "holder": "Actavis Group hf", "authorised_date": "2016-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed diacid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1064/001", "product_name": "Imlygic 10e6 plaque forming units (PFU)/mL solution for injection", "holder": "Amgen Europe B.V.", "authorised_date": "2015-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XC", "L01XC19" ], "active_substances": [ "Talimogene laherparepvec" ], "routes": [ "Intralesional use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1064/002", "product_name": "Imlygic 10e8 plaque forming units (PFU)/mL solution for injection", "holder": "Amgen Europe B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XC", "L01XC19" ], "active_substances": [ "Talimogene laherparepvec" ], "routes": [ "Intralesional use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1065/001", "product_name": "Eptifibatide Accord 0.75 mg/ml solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2016-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC", "B01AC16" ], "active_substances": [ "Eptifibatide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", 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[ "N04" ], "active_substances": [ "Opicapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1066/002-007", "product_name": "Ongentys 50 mg hard capsules", "holder": "BIAL-Portela & Ca, S.A.", "authorised_date": "2016-06-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N04BX" ], "active_substances": [ "Opicapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1067/001-003", "product_name": "Lopinavir/Ritonavir Viatris 100 mg/25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE03" ], "active_substances": [ "Lopinavir", "Ritonavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1067/004-008", "product_name": "Lopinavir/Ritonavir Viatris 200 mg/50 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR10" ], "active_substances": [ "Lopinavir", "Ritonavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not 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"dosage_form": "Film-coated tablet", "atc_codes": [ "N07XX", "N07XX11" ], "active_substances": [ "Pitolisant hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1070/002", "product_name": "Oncaspar 750 U/ml powder for solution for injection/infusion", "holder": "Les Laboratoires Servier", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01XX24" ], "active_substances": [ "Pegaspargase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1071/001", "product_name": "Pemetrexed Accord 100 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2016-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed disodium", "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1071/002", "product_name": "Pemetrexed Accord 500 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2016-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01B" ], "active_substances": [ "Pemetrexed disodium", "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1071/003", "product_name": "Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2016-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01B" ], "active_substances": [ "Pemetrexed", "Pemetrexed disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1071/004-007", "product_name": "Pemetrexed Accord 25 mg/ml concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2016-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA04" ], "active_substances": [ "Pemetrexed", "Pemetrexed Disodium Hemipentahydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1072/001-002", "product_name": "Spectrila 10,000 U powder for concentrate for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX02" ], "active_substances": [ "Recombinant l-asparaginase" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1073/001-004", "product_name": "Briviact 10 mg film-coated tablets", "holder": "UCB Pharma S.A.", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1073/013-016", "product_name": "Briviact 75 mg film-coated tablets", "holder": "UCB Pharma S.A.", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1073/017-020", "product_name": "Briviact 100 mg film-coated tablets", "holder": "UCB Pharma S.A.", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1073/021", "product_name": "Briviact 10 mg/ml oral solution", "holder": "UCB Pharma S.A.", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1073/022", "product_name": "Briviact 10 mg/ml solution for injection/infusion", "holder": "UCB Pharma S.A.", "authorised_date": "2016-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1074/001", "product_name": "Benepali 50 mg solution for injection in pre-filled syringe", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1074/002", "product_name": "Benepali 50 mg solution for injection in pre-filled pen", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar 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"Capsule, hard", "atc_codes": [ "B03AB", "B03AB10" ], "active_substances": [ "Ferric maltol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1076/002", "product_name": "Kovaltry 250 IU powder and solvent for solution for injection", "holder": "Bayer AG", "authorised_date": "2016-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1076/004", "product_name": "Kovaltry 500 IU powder and solvent for solution for injection", "holder": "Bayer Pharma AG", "authorised_date": "2016-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1076/006", "product_name": "Kovaltry 1000 IU powder and solvent for solution for injection", "holder": "Bayer Pharma AG", "authorised_date": "2016-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ 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"EU/1/15/1076/010", "product_name": "Kovaltry 3000 IU powder and solvent for solution for injection", "holder": "Bayer Pharma AG", "authorised_date": "2016-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Octocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1079/001-007", "product_name": "Vaxelis suspension for injection in pre-filled syringe. 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"registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC", "L04AC13" ], "active_substances": [ "Ixekizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/1085/007", "product_name": "Taltz 40mg Solution for injection", "holder": "Eli Lilly Kinsale Limited", "authorised_date": "2016-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC13" ], "active_substances": [ "Ixekizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/989/001", "product_name": "Tenkasi 400 mg powder for concentrate for solution for infusion", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2015-03-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA05" ], "active_substances": [ "Oritavancin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/15/989/002", "product_name": "Tenkasi 1200 mg powder for concentrate for solution for infusion", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", 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"registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AB", "L04AB02" ], "active_substances": [ "Infliximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1108/001-004", "product_name": "Qtern 5 mg/10 mg film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "2016-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD21" ], "active_substances": [ "Dapagliflozin", "Saxagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed 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"HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1115/003-005", "product_name": "Pemetrexed Fresenius Kabi 25 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"L01XX19" ], "active_substances": [ "Irinotecan hydrochloride trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1131/001-002", "product_name": "Thorinane", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2016-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intraarterial use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 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Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1131/009-010", "product_name": "Thorinane", "holder": "Pharmathen S.A.", "authorised_date": "2016-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intraarterial use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1132/001-002", "product_name": "Inhixa 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringe", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2016-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intraarterial use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1132/003-004", "product_name": "Inhixa 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringe", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2016-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intraarterial use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product 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"product_name": "Inhixa 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringe", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2016-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intraarterial use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1132/009-010", "product_name": "Inhixa 10,000 IU (100 mg)/1 mL solution for injection in pre-filled syringe", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2016-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intraarterial use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1132/069", "product_name": "Inhixa 12,000 IU (120 mg)/0.8 mL solution for injection in pre-filled syringe", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2018-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1132/070", "product_name": "Inhixa 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringe", "holder": "Techdow Pharma Netherlands B.V", "authorised_date": "2018-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1132/071", "product_name": "Inhixa 30,000 IU (300 mg)/3 mL solution for injection in 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"B01AB05" ], "active_substances": [ "Enoxaparin sodium", "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1133/001-006", "product_name": "Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Emtricitabine", "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 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"2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1140/022-029", "product_name": "Darunavir Viatris 400 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1140/030-038", "product_name": "Darunavir Viatris 600mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1140/039-045", "product_name": "Darunavir Viatris 800 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1141/001", "product_name": "SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation", "holder": "Advanced Accelerator Applications", "authorised_date": "2016-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09IX", "V09IX09" ], "active_substances": [ "Edoteotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1142/001-004", "product_name": "Parsabiv 2.5 mg solution for injection", "holder": "Amgen Europe B.V.,", "authorised_date": "2016-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H05BX", "H05BX04" ], "active_substances": [ "Etelcalcetide hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1142/005-008", "product_name": "Parsabiv 5 mg solution for injection", "holder": "Amgen Europe B.V.,", "authorised_date": "2016-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H05BX", "H05BX04" ], "active_substances": [ "Etelcalcetide hydrochloride" ], "routes": 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"2016-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC27" ], "active_substances": [ "Olaratumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1144/001-007", "product_name": "Ivabradine Zentiva 5 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2016-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"Film-coated tablet", "atc_codes": [ "A10BD", "A10BD19" ], "active_substances": [ "Empagliflozin", "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1146/010-018", "product_name": "Glyxambi 25 mg/5 mg film-coated tablets", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2016-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD19" ], "active_substances": [ "Empagliflozin", "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1147/001-002", "product_name": "IBRANCE 75 mg hard capsules", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2016-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EF01" ], "active_substances": [ "Palbociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1147/0012-013", "product_name": "IBRANCE 100 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE33" ], "active_substances": [ "Palbociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1147/003-004", "product_name": "IBRANCE 100 mg hard capsules", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2016-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EF01" ], "active_substances": [ "Palbociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1147/005-006", "product_name": "IBRANCE 125 mg hard capsules", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2016-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EF01" ], "active_substances": [ "Palbociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1147/010-011", "product_name": "IBRANCE 75 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE33" ], "active_substances": [ "Palbociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1147/014-015", "product_name": "IBRANCE 125 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE33" ], "active_substances": [ "Palbociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1148/001-002", "product_name": "Emtricitabine/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2016-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Tenofovir disoproxil", "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1150/004", "product_name": "REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen", "holder": "Ferring Pharmaceuticals A/S", "authorised_date": "2016-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03GA", "G03GA10" ], "active_substances": [ "Follitropin delta" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1150/005", "product_name": "REKOVELLE 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"dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1154/001-002", "product_name": "Vemlidy 25 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2017-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF", "J05AF13" ], "active_substances": [ "Tenofovir alafenamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1155/001", "product_name": "Kyntheum 210 mg solution for injection in pre-filled syringe", "holder": "LEO Pharma A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC", "L04AC12" ], "active_substances": [ "Brodalumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1156/001", "product_name": "ZINPLAVA 25 mg/mL concentrate for solution for infusion", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2017-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J06BB", "J06BB21" ], "active_substances": [ "Bezlotoxumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1157/001-002", "product_name": "Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen", "holder": "Sanofi-Aventis Groupe", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine", "Lixisenatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1157/003-004", "product_name": "Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen", "holder": "Sanofi-Aventis Groupe", "authorised_date": "2017-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Lixisenatide", "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1158/001", "product_name": "AFSTYLA 250 IU powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution 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2001/83/EC)" }, { "licence_number": "EU/1/16/1158/003", "product_name": "AFSTYLA 1000 IU powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Lonoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1158/004", "product_name": "AFSTYLA 1500 IU powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for 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2001/83/EC)" }, { "licence_number": "EU/1/16/1158/006", "product_name": "AFSTYLA 2500 IU powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Lonoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1158/007", "product_name": "AFSTYLA 3000 IU powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2017-01-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for 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"licence_number": "EU/1/16/1160/001-006", "product_name": "Fiasp 100 units/mL FlexTouch solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2017-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AB", "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1161/001-002", "product_name": "Movymia 20 micrograms/80 microliters solution for injection", "holder": "Stada Arzneimittel AG", "authorised_date": "2017-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H05AA", "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/001", "product_name": "AMGEVITA 20 mg solution for injection in pre-filled syringe", "holder": "Amgen Europe B.V.,", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/002-009", "product_name": "AMGEVITA 40 mg solution for injection in pre-filled syringe", "holder": "Amgen Europe B.V.,", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB", "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/010", "product_name": "AMGEVITA 20 mg solution for injection in pre-filled syringe", "holder": "Amgen Europe B.V.,", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/011-013", "product_name": "AMGEVITA 40 mg solution for injection in pre-filled syringe", "holder": "Amgen Europe B.V.,", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/014- 016", "product_name": "AMGEVITA 40 mg solution for injection in pre-filled pen", "holder": "Amgen Europe B.V.,", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/017-019", "product_name": "AMGEVITA 80 mg solution for injection in pre-filled syringe", "holder": "Amgen Europe B.V.,", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1164/020- 022", "product_name": "AMGEVITA 80 mg solution for injection in pre-filled pen", "holder": "Amgen Europe B.V.,", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1165/001", "product_name": "Lifmior", "holder": "Pfizer Europe MA EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1165/002-004", "product_name": "Lifmior", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1165/005-007", "product_name": "Lifmior", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1165/008-010", "product_name": "Lifmior", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1165/011-013", "product_name": "Lifmior", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1167/001", "product_name": "Truxima 500 mg concentrate for solution for infusion", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2017-02-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1167/002", "product_name": "Truxima 100 mg concentrate for solution for infusion", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1168/001", "product_name": "Vihuma 250 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2017-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1168/004", "product_name": "Vihuma 2000 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1168/007", "product_name": "Vihuma 4000 IU powder and solvent for solution for injection", "holder": "Octapharma AB", "authorised_date": "2018-12-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "Simoctocog alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1169/001", "product_name": "Alecensa 150 mg hard capsules", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01ED03" ], "active_substances": [ "Alectinib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1170/001-008", "product_name": "Olumiant 2 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA37" ], 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"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/16/1171/001", "product_name": "Ledaga 160 micrograms/g gel", "holder": "Helsinn Birex Pharmaceuticals Limited", "authorised_date": "2017-03-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "L01AA", "L01AA05" ], "active_substances": [ "Chlormethine hydrochloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1172/001", "product_name": "Jylamvo 2 mg/ml oral solution", "holder": "Oresund Pharma ApS", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "L01BA", "L01BA01" ], 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"Tofacitinib citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1178/005-009", "product_name": "XELJANZ 10 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA29" ], "active_substances": [ "Tofacitinib citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1178/010-013", "product_name": "XELJANZ 11 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "L01XC32", "L04AA" ], "active_substances": [ "TOFACITINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1178/015", "product_name": "XELJANZ 1 mg/mL oral solution", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "L04AA29" ], "active_substances": [ "TOFACITINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1179/001-003", "product_name": "Veltassa 8.4 g powder for oral suspension", "holder": "Vifor Fresenius Medical Care Renal Pharma France", "authorised_date": "2017-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "V03AE", "V03AE09" ], "active_substances": [ "Patiromer sorbitex calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1179/004-006", "product_name": "Veltassa 16.8 g powder for oral suspension", "holder": "Vifor Fresenius Medical Care Renal Pharma France", "authorised_date": "2017-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "V03AE", "V03AE09" ], "active_substances": [ "Patiromer sorbitex calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1179/007-008", "product_name": "Veltassa 25.2 g powder for oral suspension", "holder": "Vifor Fresenius Medical Care Renal Pharma France", "authorised_date": "2017-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "V03AE", "V03AE09" ], "active_substances": [ "Patiromer sorbitex calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 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"M09AX02" ], "active_substances": [ "Spheroids of human autologous matrix-associated chondrocytes" ], "routes": [ "Intraarticular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1182/001-004", "product_name": "Emtricitabine/Tenofovir disoproxil Krka d.d 200 mg/245 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Tenofovir disoproxil", "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1183/001", "product_name": "Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed ditromethamine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1183/002", "product_name": "Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed ditromethamine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1183/003", "product_name": "Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed ditromethamine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1184/001-002", "product_name": "Riximyo 100 mg concentrate for solution for infusion", "holder": "Sandoz GmbH", "authorised_date": "2017-06-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1184/003-004", "product_name": "Riximyo 500 mg concentrate for solution for infusion", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1185/001-002", "product_name": "Rixathon 100 mg concentrate for solution for infusion", "holder": "Sandoz GmbH", "authorised_date": "2017-06-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1185/003-004", "product_name": "Rixathon 500 mg concentrate for solution for infusion", "holder": "Sandoz GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1186/001", "product_name": "Axumin 1,600 MBq/mL solution for injection", "holder": "Blue Earth Diagnostics Ireland Ltd", "authorised_date": "2017-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09IX", "V09IX12" ], "active_substances": [ "Fluciclovine (18f)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1186/002", "product_name": "Axumin 3,200 MBq/mL solution for injection", "holder": "Blue Earth Diagnostics Ireland Ltd", "authorised_date": "2017-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09IX", "V09IX12" ], "active_substances": [ "Fluciclovine (18f)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1187/001-006", "product_name": "Trumenba suspension for injection in pre-filled syringe. 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"dosage_form": "Solution for injection", "atc_codes": [ "N07" ], "active_substances": [ "Nusinersen" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1188/002", "product_name": "Spinraza 28 mg solution for injection", "holder": "Biogen Netherlands B.V.", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M09AX07" ], "active_substances": [ "Nusinersen sodium" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1188/003", "product_name": "Spinraza 50 mg solution for injection", "holder": "Biogen Netherlands B.V.", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M09AX07" ], "active_substances": [ "Nusinersen sodium" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1189/001-002", "product_name": "elmiron 100 mg capsules, hard", "holder": "bene-Arzneimittel GmbH", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04BX", "G04BX15" ], "active_substances": [ "Pentosan Polysulfate Sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1190/001-007", "product_name": "Ivabradine Accord 5 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1190/008-014", "product_name": "Ivabradine Accord 7.5 mg film-coated tablets", "holder": "Accord Healthcare 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not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1192/001", "product_name": "Brineura 150 mg solution for infusion", "holder": "BioMarin International Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "A16AB" ], "active_substances": [ "Cerliponase" ], "routes": [ "Intracerebral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1193/001", "product_name": "Refixia 500 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD04" ], "active_substances": [ "Nonacog beta pegol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1193/002", "product_name": "Refixia 1 000 IU powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD04" ], "active_substances": [ "Nonacog beta pegol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD04" ], "active_substances": [ "Nonacog beta pegol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1194/001-008", "product_name": "Febuxostat Viatris 80 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2017-06-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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"EU/1/17/1195/009-012", "product_name": "Erelzi 50 mg solution for injection in pre-filled pen", "holder": "Sandoz GmbH", "authorised_date": "2017-06-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "*** AWAITING VALUE ***" ], "supply_status": "", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1196/001-002", "product_name": "Kevzara 150 mg solution for injection in pre-filled syringe", "holder": "Sanofi Winthrop Industrie", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC", "L04AC14" ], "active_substances": [ "Sarilumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1196/003-008", "product_name": "Kevzara 200 mg solution for injection in pre-filled syringe", "holder": "Sanofi Winthrop Industrie", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC", "L04AC14" ], "active_substances": [ "Sarilumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1196/013", "product_name": "Kevzara 175 mg/ml solution for injection", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC14" ], "active_substances": [ "Sarilumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1197/01", "product_name": "OXERVATE 20 micrograms/ml eye drops, solution", "holder": "Dompe farmaceutici SpA", "authorised_date": "2017-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01" ], "active_substances": [ "Recombinant human nerve growth factor (rhngf)" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1199/001", "product_name": "Cuprior 150 mg film-coated tablets", "holder": "gmp-orphan SA", "authorised_date": "2017-09-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A16AX", "A16AX12" ], "active_substances": [ "Trientine tetrahydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1200/001", "product_name": "BESPONSA 1 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2017-06-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate 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"product_name": "Skilarence 120 mg gastro-resistant tablets", "holder": "Almirall, S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1202/001-002", "product_name": "Ucedane 200 mg dispersible tablets", "holder": "Eurocept International BV", "authorised_date": "2017-06-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "A16AA", "A16AA05" ], "active_substances": [ "Carglumic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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Kft.", "authorised_date": "2017-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1208/001-003", "product_name": "Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2017-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AL", "R03AL09" ], "active_substances": [ "Beclometasone dipropionate", "Formoterol fumarate dihydrate", "Glycopyrronium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1208/004", "product_name": "Trimbow", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2017-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AL", "R03AL09" ], "active_substances": [ "Glycopyrronium bromide", "Formoterol fumarate dihydrate", "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1208/005", "product_name": "Trimbow", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2017-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AL", "R03AL09" ], "active_substances": [ "Beclometasone dipropionate", "Glycopyrronium bromide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1208/006-009", "product_name": "Trimbow 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2017-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, 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"Capsule, hard", "atc_codes": [ "N05AX", "N05AX15" ], "active_substances": [ "Cariprazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1209/021-028", "product_name": "Reagila 4.5 mg hard capsules", "holder": "Gedeon Richter Plc", "authorised_date": "2017-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05AX", "N05AX15" ], "active_substances": [ "Cariprazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1209/029-036", "product_name": "Reagila 6 mg hard capsules", "holder": "Gedeon Richter Plc", "authorised_date": "2017-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05AX", "N05AX15" ], "active_substances": [ "Cariprazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1209/043-044", "product_name": "Reagila 1.5 mg orodispersible tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2024-08-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AX15" ], "active_substances": [ "Cariprazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AX15" ], "active_substances": [ "Cariprazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1209/049-050", "product_name": "Reagila 6 mg orodispersible tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2024-08-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AX15" ], "active_substances": [ "Cariprazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1210/001", "product_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 600 mg/200 mg/245 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2017-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR06" ], "active_substances": [ "Tenofovir disoproxil phosphate", "Efavirenz", "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1211/001-003", "product_name": "Entecavir Accord 0.5 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-09-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF", "J05AF10" ], "active_substances": [ "Entecavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1211/004-006", "product_name": "Entecavir Accord 1 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-09-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF", "J05AF10" ], "active_substances": [ "Entecavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1212/001-006", "product_name": "MAVENCLAD 10 mg tablets", "holder": "Merck Europe B.V.", "authorised_date": "2017-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AA" ], "active_substances": [ "Cladribine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1213/001", "product_name": "Maviret 100 mg/40 mg film-coated tablets", "holder": "AbbVie Deutschland GmbH & Co. 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"dosage_form": "Capsule, hard", "atc_codes": [], "active_substances": [ "Tivozanib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1216/001-004", "product_name": "Imraldi 40 mg solution for injection in pre-filled syringe", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1216/005-008", "product_name": "Imraldi 40 mg solution for injection in pre-filled pen", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1216/009", "product_name": "Imraldi 40 mg/0.8 ml solution for injection", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2019-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1218/001", "product_name": "Rydapt 25 mg soft capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2017-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01XE", "L01XE39" ], "active_substances": [ "Midostaurin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1219/001-004", "product_name": "Verkazia 1 mg/mL eye drops, emulsion", "holder": "Santen OY", "authorised_date": "2018-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, emulsion", "atc_codes": [ "S01XA", "S01XA18" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1220/001", "product_name": "Tecentriq 1200 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2017-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FF05" ], "active_substances": [ "Atezolizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1220/002", "product_name": "Tecentriq 840 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2019-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FF05" ], "active_substances": [ "Atezolizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1220/003", "product_name": "Tecentriq 1875 mg solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2024-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01FF05" ], "active_substances": [ "Atezolizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1221/001-012", "product_name": "Kisqali 200 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2017-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01X" ], "active_substances": [ "Ribociclib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1222/001-002", "product_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan 600 mg/200 mg/245 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2017-09-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR06" ], "active_substances": [ "Efavirenz", "Tenofovir disoproxil maleate", "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1223/001", "product_name": "Vosevi 400 mg/100 mg/100 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2017-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05A" ], "active_substances": [ "Sofosbuvir", "Velpatasvir", "Voxilaprevir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1223/002", "product_name": "Vosevi 200 mg/50 mg/50 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2021-04-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05A" ], "active_substances": [ "Sofosbuvir", "Velpatasvir", "Voxilaprevir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1224/001-002", "product_name": "Xermelo 250 mg film-coated tablets", "holder": "Serb S.A.S.", "authorised_date": "2017-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A16AX" ], "active_substances": [ "Telotristat etiprate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1225/001", "product_name": "Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2017-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05A" ], "active_substances": [ "Tenofovir alafenamide", "Darunavir ethanolate", 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"EU/1/17/1230/001-004", "product_name": "Lacosamide Accord 50 mg film coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1230/005-008", "product_name": "Lacosamide Accord 100 mg film coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], 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"2017-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1230/026-027", "product_name": "Lacosamide Accord 10 mg/ml solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2021-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1231/001-002", "product_name": "Ocrevus 300 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA36" ], "active_substances": [ "Ocrelizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1231/003", "product_name": "Ocrevus 920 mg solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2024-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for 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"product_name": "Zubsolv 5.7 mg/1.4 mg Sublingual tablet", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC", "N07BC51" ], "active_substances": [ "Naloxone hydrochloride dihydrate", "Buprenorphine hydrochloride" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1233/005", "product_name": "Zubsolv 8.6 mg/2.1 mg Sublingual tablet", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC", "N07BC51" ], "active_substances": [ "Buprenorphine 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"EU/1/17/1234/001", "product_name": "Tremfya 100 mg Solution for injection pre-filled syringe", "holder": "Janssen-Cilag International NV", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04A" ], "active_substances": [ "Guselkumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1234/006-007", "product_name": "Tremfya 200 mg Solution for injection pre-filled syringe", "holder": "Janssen-Cilag International NV", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "L04AC16" ], "active_substances": [ "Guselkumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1234/008-009", "product_name": "Tremfya 200 mg Solution for injection pre-filled pen", "holder": "Janssen-Cilag International NV", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "L04AC16" ], "active_substances": [ "Guselkumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1234/012", "product_name": "Tremfya 45 mg/0.45 mL solution for injection in pre-filled pen", "holder": "Janssen-Cilag International NV", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC16" ], "active_substances": [ "Guselkumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1235/001-003", "product_name": "Zejula 100 mg Capsule, hard", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2017-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XX", "L01XX54" ], "active_substances": [ "Niraparib tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1235/004-005", "product_name": "Zejula 100 mg Film-coated tablet", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2022-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XK02" ], "active_substances": [ "Niraparid tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1236/001-003", "product_name": "Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, 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"R03AL08" ], "active_substances": [ "Fluticasone furoate", "Umeclidinium bromide", "Vilanterol trifenatate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1238/001", "product_name": "Nyxoid 1.8 mg Nasal spray, solution", "holder": "Mundipharma Corporation (Ireland) Limited", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, solution in single-dose container", "atc_codes": [ "V03AB", "V03AB15" ], "active_substances": [ "Naloxone hydrochloride dihydrate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1239/001-002", "product_name": "VeraSeal 80 mg/ml/500 IU/ml Solutions for sealant", "holder": "Instituto Grifols S.A.", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for sealant", "atc_codes": [ "B02BC" ], "active_substances": [ "Human fibrinogen" ], "routes": [ "Epilesional use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1239/003-004", "product_name": "VeraSeal 80 mg/ml/500 IU/ml Solutions for sealant", "holder": "Instituto Grifols S.A.", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for sealant", "atc_codes": [ "B02BC" ], "active_substances": [ "Human fibrinogen" ], "routes": [ "Epilesional use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1241/001", "product_name": "Ontruzant 150 mg Powder for concentrate for solution for infusion", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2017-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1242/001-003", "product_name": "Ritonavir Viatris 100 mg Film-coated tablet", "holder": "Viatris Limited", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE03" ], "active_substances": [ "Ritonavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1244/001-006", "product_name": "Tacforius 0.5 mg Prolonged-release capsule, hard", "holder": "Teva B.V.", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1244/007-014", "product_name": "Tacforius 1 mg Prolonged-release capsule, hard", "holder": "Teva B.V.", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1244/015-020", "product_name": "Tacforius 3 mg Prolonged-release capsule, hard", "holder": "Teva B.V.", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1244/021-026", "product_name": "Tacforius 5 mg Prolonged-release capsule, hard", "holder": "Teva B.V.", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05" ], "active_substances": [ "LETERMOVIR" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1245/003", "product_name": "PREVYMIS 240 mg Concentrate for solution for infusion", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2018-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J05" ], "active_substances": [ "LETERMOVIR" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 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"LETERMOVIR" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1245/006", "product_name": "PREVYMIS 120 mg granules in sachet", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2025-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "J05AX18" ], "active_substances": [ "LETERMOVIR" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1246/001-002", "product_name": "MVASI 25 mg/mL Concentrate for solution for infusion", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2018-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC07" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1247/001-004", "product_name": "ADYNOVI 250 IU Powder and solvent for solution for injection", "holder": "Baxalta Innovations GmbH", "authorised_date": "2018-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Rurioctocog alfa pegol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1247/005-008", "product_name": "ADYNOVI 500 IU Powder and solvent for solution for injection", "holder": "Baxalta Innovations GmbH", "authorised_date": "2018-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Rurioctocog alfa pegol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1247/010-012", "product_name": "ADYNOVI 1000 IU Powder and solvent for 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"atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1249/005-008", "product_name": "Darunavir Krka 600 mg Film-coated tablet", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-01-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1249/009-010", "product_name": "Darunavir Krka 800 mg Film-coated tablet", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-01-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1250/001", "product_name": "Rubraca 200 mg Film-coated tablet", "holder": "pharmaand GmbH", "authorised_date": "2018-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX", "L01XX55" ], "active_substances": [ "Rucaparib camsylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may 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"Film-coated tablet", "atc_codes": [ "L01XX", "L01XX55" ], "active_substances": [ "Rucaparib camsylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1251/002", "product_name": "Ozempic 0.25 mg solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1251/003-004", "product_name": "Ozempic 0.5 mg solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2018-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [], "active_substances": [ "Semaglutide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1251/005-006", "product_name": "Ozempic 1 mg solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2018-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1251/010-011", "product_name": "Ozempic 2 mg solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1251/012-013", "product_name": "Ozempic 0.5 mg solution for injection 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"Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1254/007-011", "product_name": "Jorveza 0.5 mg orodispersible tablets", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2020-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1254/012", "product_name": "Jorveza 0.2 mg/mL oral suspension For children and adolescents aged 2-17 years", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2026-04-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1255/001", "product_name": "Intrarosa 6.5 mg pessary", "holder": "Endoceutics S.A.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G03" ], "active_substances": [ "Prasterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1256/001", "product_name": "Anagrelide Viatris 0.5 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2018-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XX", "L01XX35" ], "active_substances": [ "Anagrelide hydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1257/001", "product_name": "Herzuma 150 mg powder for concentrate for solution for infusion", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2018-02-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1257/002-003", "product_name": "Herzuma 420 mg powder for concentrate for solution for infusion", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2018-02-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1258/001-003", "product_name": "Lamzede 10 mg powder for solution 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"dosage_form": "Granules", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1260/004", "product_name": "Alkindi 5 mg granules in capsules for opening", "holder": "Immedica Pharma AB", "authorised_date": "2018-02-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1262/001", "product_name": "CRYSVITA 10 mg solution for injection", "holder": "Kyowa Kirin Holdings B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX", "M05BX05" ], "active_substances": [ "Recombinant human igg1 monoclonal antibody to fibroblast growth factor 23" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/17/1262/002", "product_name": "CRYSVITA 20 mg solution for injection", "holder": "Kyowa Kirin Holdings B.V.", "authorised_date": "2018-02-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX", "M05BX05" ], "active_substances": [ "Recombinant human 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"licence_number": "EU/1/17/1263/001-002", "product_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Krka 600 mg/200 mg/245 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR06" ], "active_substances": [ "Tenofovir disoproxil succinate", "Efavirenz", "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1264/001-004", "product_name": "Alunbrig 30 mg film-coated tablets", "holder": "Takeda Pharma A/S", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE43" ], "active_substances": [ "Brigatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1264/005-008", "product_name": "Alunbrig 90 mg film-coated tablets", "holder": "Takeda Pharma A/S", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE43" ], "active_substances": [ "Brigatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1264/009-010", "product_name": "Alunbrig 180 mg film-coated tablets", "holder": "Takeda Pharma A/S", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE43" ], "active_substances": [ "Brigatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1265/001-007", "product_name": "Segluromet 2.5 mg/850 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD23" ], "active_substances": [ "Metformin Hydrochloride", "Ertugliflozin l-pyroglutamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD23" ], "active_substances": [ "Ertugliflozin l-pyroglutamic acid", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1265/022-028", "product_name": "Segluromet 7.5 mg/1 000 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD23" ], "active_substances": [ "Ertugliflozin l-pyroglutamic acid", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD", "A10BD24" ], "active_substances": [ "Ertugliflozin l-pyroglutamic acid", "Sitagliptin phosphate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1267/001-006", "product_name": "Steglatro 5 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2018-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK", "A10BK04" ], "active_substances": [ "Ertugliflozin l-pyroglutamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1267/007-012", "product_name": "Steglatro 15 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV", "authorised_date": "2018-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK", "A10BK04" ], "active_substances": [ "Ertugliflozin l-pyroglutamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1270/001-004", "product_name": "Semglee 100 units/ml solution for injection in pre-filled pen", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE", "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1271/001", "product_name": "Hemlibra 30 mg/mL solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B02BX", "B02BX06" ], "active_substances": [ "Emicizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1271/002-005", "product_name": "Hemlibra 150 mg/mL solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2018-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B02BX", "B02BX06" ], "active_substances": [ "Emicizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1271/006", "product_name": "Hemlibra 30 mg/mL solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2018-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B02BX06" ], "active_substances": [ "Emicizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1272/001-002", "product_name": "Shingrix powder and suspension for suspension for injection. Herpes zoster vaccine (recombinant, adjuvanted).", "holder": "GlaxoSmithKline Biologicals S.A.", "authorised_date": "2018-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and suspension for suspension for injection", "atc_codes": [ "J07BK", "J07BK03" ], "active_substances": [ "Recombinant varicella zoster virus surface glycoprotein e" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1272/003-004", "product_name": "Shingrix suspension for injection in pre-filled syringe Herpes zoster vaccine (recombinant, adjuvanted)", "holder": "GlaxoSmithKline Biologicals", "authorised_date": "2025-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BK03" ], "active_substances": [ "Recombinant Varicella zoster virus glycoprotein E" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1273/001", "product_name": "Prasugrel Viatris 5 mg", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2018-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC22" ], "active_substances": [ "Prasugrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1273/002", "product_name": "Prasugrel Viatris 10 mg", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2018-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC22" ], "active_substances": [ "Prasugrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1274/001-005", "product_name": "Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2018-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AL", "R03AL09" ], "active_substances": [ "Beclometasone dipropionate", "Formoterol fumarate dihydrate", "GLYCOPYRRONIUM" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1274/006-008", "product_name": "Trydonis 88 micrograms/5 micrograms/9 micrograms inhalation powder", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2018-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AL09" ], "active_substances": [ "Beclometasone dipropionate", "Formoterol fumarate dihydrate", "Glycopyrronium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1276/001-002", "product_name": "Myalepta 11.3 mg powder for solution for injection", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2018-07-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "A16AA" ], "active_substances": [ "Metreleptin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1277/001", "product_name": "MYLOTARG 5 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2018-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC05" ], "active_substances": [ "Gemtuzumab ozogamicin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1278/001", "product_name": "Carmustine medac 100 mg powder and solvent for concentrate for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for concentrate for solution for infusion", "atc_codes": [ "L01AD01" ], "active_substances": [ "Carmustine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1279/001-002", "product_name": "AMGLIDIA 0.6 mg/mL oral suspension", "holder": "AMMTek", "authorised_date": "2018-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A10BB", "A10BB01" ], "active_substances": [ "Glibenclamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1279/003-004", "product_name": "AMGLIDIA 6 mg/mL oral suspension", "holder": "AMMTek", "authorised_date": "2018-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A10BB", "A10BB01" ], "active_substances": [ "Glibenclamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1280/001-005", "product_name": "Zessly 100 mg powder for concentrate for solution for infusion", "holder": "Sandoz GmbH", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AB", "L04AB02" ], "active_substances": [ "Infliximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1281/001", "product_name": "KANJINTI 150 mg powder for concentrate for solution for infusion", "holder": "Amgen Europe B.V.", "authorised_date": "2018-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1281/002", "product_name": "KANJINTI 420 mg powder for concentrate for solution for infusion", "holder": "Amgen Europe B.V.", "authorised_date": "2018-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1282/001-002", "product_name": "Juluca 50 mg/25 mg film-coated tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2018-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR21" ], "active_substances": [ "Dolutegravir", "Rilpivirine hydrochloride", "Sodium starch glycolate ep", "Iron oxide yellow (E172)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1284/001-002", "product_name": "Dzuveo 30 micrograms sublingual tablet", "holder": "Laboratoire Aguettant", "authorised_date": "2018-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N01AH", "N01AH03" ], "active_substances": [ "SUFENTANIL CITRATE" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1286/001-003", "product_name": "Hyrimoz 40 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", 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}, { "licence_number": "EU/1/18/1286/007", "product_name": "Hyrimoz 20 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2020-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1286/008-009", "product_name": "Hyrimoz 80 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1286/010-011", "product_name": "Hyrimoz 80 mg solution for injection in pre-filled pen", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1287/001-003", "product_name": "Hefiya 40 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1287/004-006", "product_name": "Hefiya 40 mg solution for injection in pre-filled pen", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB", "L04AB04" ], 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"EU/1/18/1287/008-009", "product_name": "Hefiya 80 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1287/010-011", "product_name": "Hefiya 80 mg solution for injection in pre-filled pen", "holder": "Sandoz GmbH", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1289/001-002", "product_name": "Biktarvy 50 mg/200 mg/25 mg Film-coated tablet", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2018-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR20" ], "active_substances": [ "Bictegravir", "Emtricitabine", "Tenofovir alafenamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1289/005-006", "product_name": "Biktarvy 30 mg/120 mg/15 mg Film-coated tablet", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2022-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR20" ], "active_substances": [ "Bictegravir Sodium", "Emtricitabine", "Tenofovir alafenamide fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1290/001", "product_name": "Nityr 10 mg tablet", "holder": "Cycle Pharmaceuticals (Europe) Ltd", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A16AX", "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1291/001-003", "product_name": "Rizmoic 200 microgram Film-coated tablet", "holder": "Shionogi B.V.", "authorised_date": "2019-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AH05" ], "active_substances": [ "Naldemedine tosilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1293/001-003", "product_name": "Aimovig 70 mg Solution for injection", "holder": "Novartis Europharm Limited", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02CX" ], "active_substances": [ "ERENUMAB" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1293/004-006", "product_name": "Aimovig 140 mg Solution for injection", "holder": "Novartis Pharma GmbH", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N02CX07" ], "active_substances": [ "ERENUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1294/001", "product_name": "RXULTI 0.25 mg Film-coated tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX16" ], "active_substances": [ "Brexpiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1294/002", "product_name": "RXULTI 0.5 mg Film-coated tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX16" ], "active_substances": [ "Brexpiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1294/003-004", "product_name": "RXULTI 1 mg Film-coated tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX16" ], "active_substances": [ "Brexpiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1294/005", "product_name": "RXULTI 2 mg Film-coated tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX16" ], "active_substances": [ "Brexpiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1294/006", "product_name": "RXULTI 3 mg Film-coated tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX16" ], "active_substances": [ "Brexpiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1294/007", "product_name": "RXULTI 4 mg Film-coated tablet", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX16" ], "active_substances": [ "Brexpiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1295/001", "product_name": "Trazimera 150 mg powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2018-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1296/001-002", "product_name": "Tegsedi 284 mg solution for injection in pre-filled syringe", "holder": "Akcea Therapeutics Ireland Ltd", "authorised_date": "2018-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N07" ], "active_substances": [ "INOTERSEN" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1297/001", "product_name": "Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion", "holder": "Novartis Europharm Limited", "authorised_date": "2018-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01" ], "active_substances": [ "AUTOGLAS T CELLS TRANSDUCED WITH LENTIVIRAL VECTOR CONTAINING A CHIMERIC ANTIGEN RECEPTOR DIRECTED AGAINST CD1" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1298/001", "product_name": "VEYVONDI 650 IU powder and solvent for solution for injection", "holder": "Baxalta Innovations GmbH", "authorised_date": "2018-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD10" ], "active_substances": [ "VONICOG ALFA" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1298/002", "product_name": "VEYVONDI 1300 IU powder and solvent for solution for injection", "holder": "Baxalta Innovations GmbH", "authorised_date": "2018-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD10" ], "active_substances": [ "VONICOG ALFA" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1299/001", "product_name": "Yescarta 0.4 – 2 × 108 cells dispersion for infusion", "holder": "Kite Pharma EU B.V.", "authorised_date": "2018-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01X" ], "active_substances": [ "AXICABTAGENE CILOLEUCEL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1301/001", "product_name": "Mepsevii 2 mg/ml Concentrate for solution for injection", "holder": "Ultragenyx Germany GmbH", "authorised_date": "2018-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "A16AB18" ], "active_substances": [ "RECOMBINANT HUMAN BETA GLUCURONIDASE; RHGUS" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1302/001", "product_name": "Kigabeq 100 mg Soluble tablet", "holder": "Orphelia Pharma SA", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "N03AG04" ], "active_substances": [ "Vigabatrin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1302/002", "product_name": "Kigabeq 500 mg Soluble tablet", "holder": "Orphelia Pharma SA", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "N03AG04" ], "active_substances": [ "Vigabatrin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1305/001", "product_name": "Cablivi 10 mg Powder and solvent for solution for injection", "holder": "Ablynx", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B01AX07" ], "active_substances": [ "caplacizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1306/001", "product_name": "Symkevi 100 mg/150 mg Film-coated tablet", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2018-10-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX31" ], "active_substances": [ "TEZACAFTOR", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1306/002", "product_name": "Symkevi 50 mg/75 mg Film-coated tablet", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2020-11-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX31" ], "active_substances": [ "TEZACAFTOR", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1307/001-003", "product_name": "Verzenios 50 mg Film-coated tablet", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2018-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EF03" ], "active_substances": [ "ABEMACICLIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1307/004-006", "product_name": "Verzenios 100 mg Film-coated tablet", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2018-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EF03" ], "active_substances": [ "ABEMACICLIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1307/007-009", "product_name": "Verzenios 150 mg Film-coated tablet", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2018-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EF03" ], "active_substances": [ "ABEMACICLIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1308/001-003", "product_name": "Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion", "holder": "Jazz Pharmaceuticals Ireland Limited", "authorised_date": "2018-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XY01" ], "active_substances": [ "Cytarabine", "DAUNOMYCIN HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1310/001", "product_name": "Deferiprone Lipomed 500 mg Film-coated tablet", "holder": "Lipomed GmbH", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AC02" ], "active_substances": [ "Deferiprone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1311/001", "product_name": "Nerlynx 40 mg Film-coated tablet", "holder": "Pierre Fabre Medicament", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EH02" ], "active_substances": [ "Neratinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1312/001", "product_name": "Xerava 50 mg Powder for concentrate for solution for infusion", "holder": "Paion Pharma GmbH", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01AA13" ], "active_substances": [ "ERAVACYCLINE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1312/003-004", "product_name": "Xerava 100 mg Powder for concentrate for solution for infusion", "holder": "Paion Pharma GmbH", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01AA13" ], "active_substances": [ "ERAVACYCLINE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1313/001", "product_name": "Pelgraz 6 mg Solution for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2018-09-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1314/001", "product_name": "Braftovi 50 mg Hard capsule", "holder": "Pierre Fabre Medicament", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EC03" ], "active_substances": [ "ENCORAFENIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1314/002", "product_name": "Braftovi 75 mg Hard capsule", "holder": "Pierre Fabre Medicament", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, 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"Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1316/003-004", "product_name": "Lenalidomide Accord 5 mg hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1316/005", "product_name": "Lenalidomide Accord 7.5 mg hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1316/006-007", "product_name": "Lenalidomide Accord 10 mg hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1316/008-009", "product_name": "Lenalidomide 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"supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1316/011", "product_name": "Lenalidomide Accord 25 mg hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1317/001", "product_name": "Pazenir 5 mg/ml Powder for dispersion for infusion", "holder": "Ratiopharm GmbH", "authorised_date": "2019-05-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for dispersion for infusion", "atc_codes": [ "L01CD", "L01CD01" ], "active_substances": [ "Paclitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1318/001", "product_name": "Slenyto 1 mg prolonged-release tablet", "holder": "RAD Neurim Pharmaceuticals EEC SARL", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1318/003", "product_name": "Slenyto 5 mg prolonged-release tablet", "holder": "RAD Neurim Pharmaceuticals EEC SARL", "authorised_date": "2018-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1319/001-007", "product_name": "Hulio", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2018-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1319/009-010", "product_name": "Hulio 20 mg solution for injection in pre-filled syringe", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2018-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1320/001", "product_name": "Onpattro 2 mg/mL 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1323/001-002", "product_name": "Ilumetri 100 mg solution for injection in pre-filled syringe", "holder": "Almirall, S.A.", "authorised_date": "2018-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC17" ], "active_substances": [ "Tildrakizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1323/003", "product_name": "Ilumetri 200 mg solution for injection in pre-filled syringe", "holder": "Almirall S.A.", "authorised_date": "2018-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC17" ], "active_substances": [ "Tildrakizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1324/001", "product_name": "Jivi 250 IU powder and solvent for solution for injection", "holder": "Bayer AG", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "DAMOCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed 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"Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "DAMOCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1324/004", "product_name": "Jivi 2000 IU powder and solvent for solution for injection", "holder": "Bayer AG", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "DAMOCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1324/005", "product_name": "Jivi 3000 IU powder and solvent for solution for injection", "holder": "Bayer AG", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "DAMOCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1324/011-012", "product_name": "Jivi 4000 IU powder and solvent for solution for injection", "holder": "Bayer AG", "authorised_date": "2025-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "DAMOCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1325/001-004", "product_name": "Namuscla 167 mg hard capsules", "holder": "Lupin Europe GmbH", "authorised_date": "2018-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C01BB02" ], "active_substances": [ "Mexiletine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1327/001", "product_name": "Ziextenzo 6 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1328/001", "product_name": "Pelmeg 6 mg solution for injection in pre-filled syringe", "holder": "Mundipharma Corporation (Ireland) Limited", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1329/001-002", "product_name": "Fulphila 6 mg solution for injection in pre-filled syringe", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 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"active_substances": [ "VORETIGENE NEPARVOVEC" ], "routes": [ "Subretinal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1332/001-002", "product_name": "Pifeltro 100 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AG06" ], "active_substances": [ "Doravirine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1333/001-002", "product_name": "Delstrigo 100 mg/300 mg/245 mg 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"Meropenem", "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1335/001", "product_name": "POTELIGEO 4 mg/mL concentrate for solution for infusion", "holder": "Kyowa Kirin Holdings B.V.", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC25" ], "active_substances": [ "MOGAMULIZUMAB" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/001", "product_name": "Buvidal 8 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/002", "product_name": "Buvidal 16 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/003", "product_name": "Buvidal 24 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/004", "product_name": "Buvidal 32 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/005", "product_name": "Buvidal 64 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/006", "product_name": "Buvidal 96 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/007", "product_name": "Buvidal 128 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1336/009", "product_name": "Buvidal 160 mg Prolonged-release solution for injection", "holder": "Camurus AB", "authorised_date": "2018-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "N07BC01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1337/001", "product_name": "GHRYVELIN 60 mg granules for oral suspension in sachet", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "2019-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral suspension in sachet", "atc_codes": [ "V04CD06" ], "active_substances": [ "MACIMORELIN ACETATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1339/001", "product_name": "Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension", "holder": "AstraZeneca AB", "authorised_date": "2018-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AL07" ], "active_substances": [ "Formoterol fumarate dihydrate", "GLYCOPYRRONIUM" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1340/001", "product_name": "TAKHZYRO 300 mg solution for injection", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2018-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B06AC05" ], "active_substances": [ "LANADELUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1340/007-009", "product_name": "TAKHZYRO 150 mg solution for injection in pre-filled syringe", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B06AC05" ], "active_substances": [ "LANADELUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1341/001", "product_name": "Ogivri 150 mg powder for concentrate for solution for infusion", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2018-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1341/002", "product_name": "Ogivri 420 mg powder for concentrate for solution for infusion", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2018-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC03" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1342/001-003", "product_name": "Erleada 60 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2019-01-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB05" ], "active_substances": [ "APALUTAMIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1342/004-006", "product_name": "Erleada 240 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2023-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB05" ], "active_substances": [ "APALUTAMIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1343/001-006", "product_name": "Silodosin Recordati 4 mg hard capsules", "holder": "Recordati Ireland Limited", "authorised_date": "2019-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA04" ], "active_substances": [ "Silodosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1343/007-012", "product_name": "Silodosin Recordati 8 mg hard capsules", "holder": "Recordati Ireland Limited", "authorised_date": "2019-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA04" ], "active_substances": [ "Silodosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1344/001-002", "product_name": "Zirabev 25 mg/ml concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC07" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1345/001", "product_name": "Ondexxya Powder for solution for infusion", "holder": "AstraZeneca AB", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "V03AB", "V03AB38" ], "active_substances": [ "Andexanet alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1346/001", "product_name": "Miglustat Dipharma 100 mg hard capsules", "holder": "Dipharma B.V.", "authorised_date": "2019-04-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX", "A16AX06" ], "active_substances": [ "Miglustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1347/001-004", "product_name": "Febuxostat Krka 80 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2019-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1347/005-008", "product_name": "Febuxostat Krka 120 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2019-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1349/001", "product_name": "Dectova 10 mg/mL solution for infusion", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J05AH", "J05AH01" ], "active_substances": [ "Zanamivir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1350/001", "product_name": "Vantobra 170 mg nebuliser solution", "holder": "PARI Pharma GmbH", "authorised_date": "2019-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "J01GB01" ], "active_substances": [ "Tobramycin" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1351/001-002", "product_name": "Trecondi 1 g powder for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AB", "L01AB02" ], "active_substances": [ "Treosulfan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1351/003-004", "product_name": "Trecondi", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AB02" ], "active_substances": [], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1352/001", "product_name": "Besremi 250 micogram/0.5 ml Solution for injection in pre-filled pen", "holder": "Aop Orphan Pharmaceuticals GmbH", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L03AB15" ], "active_substances": [ "Ropeginterferon alfa-2b" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/18/1352/002", "product_name": "Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen", "holder": "Aop Orphan Pharmaceuticals GmbH", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AB15" ], "active_substances": [ "Ropeginterferon alfa-2b" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1354/001", "product_name": "Vizimpro 15 mg Film-coated tablet", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-04-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EB07" ], "active_substances": [ "DACOMITINIB MONOHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1354/002", "product_name": "Vizimpro 30 mg Film-coated tablet", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-04-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EB07" ], "active_substances": [ "DACOMITINIB MONOHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1354/003", "product_name": "Vizimpro 45 mg Film-coated tablet", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-04-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EB07" ], "active_substances": [ "DACOMITINIB MONOHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1355/001", "product_name": "Lorviqua 25 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-05-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01", "L01XE44" ], "active_substances": [ "LORLATINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1355/002", "product_name": "Lorviqua 100 mg film-coated tablet", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-05-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01", "L01XE44" ], "active_substances": [ "LORLATINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1356/001", "product_name": "IDACIO 40 mg/0.8 ml Solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2019-04-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1356/002", "product_name": "IDACIO 40 mg Solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2019-04-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1356/003", "product_name": "IDACIO 40 mg Solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2019-04-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1358/001-002", "product_name": "AJOVY 225 mg Solution for injection", "holder": "TEVA GmbH", "authorised_date": "2019-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N02CD03" ], "active_substances": [ "FREMANEZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1360/001-002", "product_name": "Waylivra 285 mg Solution for injection", "holder": "Akcea Therapeutics Ireland Ltd", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C10AX18" ], "active_substances": [ "VOLANESORSEN SODIUM" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/001", "product_name": "Skyrizi 75 mg Solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/002", "product_name": "Skyrizi 150 mg Solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/003", "product_name": "Skyrizi 150 mg Solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/004", "product_name": "Skyrizi 600 mg Concentrate for solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/005", "product_name": "Skyrizi 360 mg Solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/006", "product_name": "Skyrizi 90 mg Solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/007", "product_name": "Skyrizi 180 mg Solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/008-009", "product_name": "Skyrizi 180 mg solution for injection in pre-filled syringe", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1361/010", "product_name": "Skyrizi 55 mg solution for injection in pre-filled syringe", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC18" ], "active_substances": [ "RISANKIZUMAB" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1362/001", "product_name": "Palynziq 2.5 mg Solution for injection", "holder": "Biomarin International Limited", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A16A", "A16AB19" ], "active_substances": [ "PEGVALIASE" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1362/002", "product_name": "Palynziq 10 mg Solution for injection", "holder": "Biomarin International Limited", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A16A", "A16AB19" ], "active_substances": [ "PEGVALIASE" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1362/003-004", "product_name": "Palynziq 20 mg Solution for injection", "holder": "Biomarin International Limited", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A16A", "A16AB19" ], "active_substances": [ "PEGVALIASE" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1364/001", "product_name": "Nuceiva 100 U Powder for solution for injection", "holder": "Evolus Pharma Ltd.", "authorised_date": "2019-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1364/002", "product_name": "Nuceiva 50 U Powder for solution for injection", "holder": "Evolus Pharma Ltd.", "authorised_date": "2019-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1365/001", "product_name": "Cufence 100 mg hard capsule", "holder": "Univar B.V", "authorised_date": "2019-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16A", "A16AX12" ], "active_substances": [ "TRIENTINE DIHYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1365/002", "product_name": "Cufence", "holder": "Univar B.V", "authorised_date": "2023-11-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX12" ], "active_substances": [ "Trientine tetrahydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1366/001", "product_name": "Xromi 100 mg/ml oral solution", "holder": "Lipomed GmbH", "authorised_date": "2019-07-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "L01XX", "L01XX05" ], "active_substances": [ "Hydroxycarbamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1368/001-002", "product_name": "Ambrisentan Viatris 5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1368/003-004", "product_name": "Ambrisentan Viatris 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1370/001-002", "product_name": "Dovato 50 mg/300 mg tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2019-07-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR25" ], "active_substances": [ "Dolutegravir sodium", "Lamivudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1371/002", "product_name": "Ultomiris 300 mg/3 mL concentrate for solution for infusion", "holder": "Alexion Europe S.A.S.", "authorised_date": "2019-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AJ02" ], "active_substances": [ "RAVULIZUMAB" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1371/003", "product_name": "Ultomiris 1 100 mg/11 mL concentrate for solution for infusion", "holder": "Alexion Europe S.A.S.", "authorised_date": "2019-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AJ02" ], "active_substances": [ "RAVULIZUMAB" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1372/001-002", "product_name": "Striascan 74 MBq /mL solution for injection", "holder": "CIS bio International", "authorised_date": "2019-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AB", "V09AB03" ], "active_substances": [ "IOFLUPANE (1231)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1373/001-002", "product_name": "Doptelet 20 mg film-coated tablets", "holder": "Swedish Orphan Biovitrum AB(publ)", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX", "B02BX08" ], "active_substances": [ "Avatrombopag maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/001", "product_name": "Esperoct 500 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/002", "product_name": "Esperoct 1000 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/003", "product_name": "Esperoct 1500 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/004", "product_name": "Esperoct 2000 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/005", "product_name": "Esperoct 3000 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/006", "product_name": "Esperoct 4000 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1374/007", "product_name": "Esperoct 5000 IU Powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD02" ], "active_substances": [ "TUROCTOCOG ALFA PEGOL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1375/001", "product_name": "Grasustek 6 mg Solution for injection", "holder": "Juta Pharma GmbH", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AA", "L03AA13" ], "active_substances": [], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1376/001", "product_name": "LIBTAYO 350 mg Concentrate for solution for infusion", "holder": "Regeneron Ireland U.C.", "authorised_date": "2019-06-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC33" ], "active_substances": [ "CEMIPLIMAB" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1377/001-004", "product_name": "Talzenna 0.25 mg Capsule, hard", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XK04" ], "active_substances": [ "TALAZOPARIB TOSYLATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1377/005-006", "product_name": "Talzenna 1 mg Capsule, hard", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2019-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XK04" ], "active_substances": [ "TALAZOPARIB TOSYLATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { 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"Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "J02AC", "J02AC04" ], "active_substances": [ "Posaconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1380/001", "product_name": "Posaconazole AHCL 40 mg/ml oral suspension", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2019-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J02AC", "J02AC04" ], "active_substances": [ "Posaconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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"EU/1/19/1385/001", "product_name": "VITRAKVI 25 mg Capsule, hard", "holder": "Bayer AG", "authorised_date": "2019-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE53" ], "active_substances": [ "LAROTRECTINIB", "LAROTRECTINIB SULFATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1385/002", "product_name": "VITRAKVI 100 mg Capsule, hard", "holder": "Bayer AG", "authorised_date": "2019-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE" ], "active_substances": [ "LAROTRECTINIB SULFATE", "LAROTRECTINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"L01FX14" ], "active_substances": [ "Polatuzumab Vedotin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1388/002", "product_name": "Polivy 30 mg powder for concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2020-01-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX14" ], "active_substances": [ "Polatuzumab Vedotin" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1389/001", "product_name": "Epidyolex 100 mg/ml oral solution", "holder": "Jazz Pharmaceuticals Ireland Limited", "authorised_date": "2019-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX" ], "active_substances": [ "CANNABIDIOL" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1390/001-002", "product_name": "Inbrija 33 mg inhalation powder, hard capsules", "holder": "Merz Pharmaceuticals GmbH", "authorised_date": "2019-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "N04BA01" ], "active_substances": [ "Levodopa" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product 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"A. Menarini Industrie Farmaceutische Riunite S.r.l.", "authorised_date": "2019-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01MA", "J01MA23" ], "active_substances": [ "DELAFLOXACIN MEGLUMINE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1393/002-007", "product_name": "Quofenix 450 mg tablets", "holder": "A. 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"Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1398/001-003", "product_name": "Arsenic trioxide Accord 1 mg/ml concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2019-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX27" ], "active_substances": [ "Arsenic trioxide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1399/001", "product_name": "Xospata 40 mg film-coated 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"supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1403/001-003", "product_name": "GoResp Digihaler 160 microgram/4.5 microgram inhalation powder", "holder": "Teva Pharma B.V.", "authorised_date": "2020-04-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1403/004-005", "product_name": "GoResp Digihaler 320 microgram/9 microgram inhalation powder", "holder": "Teva Pharma B.V.", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1404/001-005", "product_name": "RINVOQ 15 mg prolonged-release tablets", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "L04AA", "L04AA44" ], "active_substances": [ "UPADACITINIB", "Upadacitinib Hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1404/006-009", "product_name": "RINVOQ 30 mg prolonged-release tablets", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2019-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "L04AA", "L04AA44" ], "active_substances": [ "Upadacitinib Hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1404/010-011", "product_name": "RINVOQ 45 mg prolonged-release tablets", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2022-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "L04AA", "L04AA44" ], "active_substances": [ "Upadacitinib Hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1405/001", "product_name": "Tavlesse 100 mg film-coated tablets", "holder": "Instituto Grifols S.A.", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX09" ], "active_substances": [ "FOSTAMATINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1405/002", "product_name": "Tavlesse 150 mg film-coated tablets", "holder": "Instituto Grifols S.A.", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX09" ], "active_substances": [ "FOSTAMATINIB" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1406/001-002", "product_name": "Baqsimi 3 mg nasal powder in single-dose container", "holder": "Amphastar France Pharmaceuticals, S.A.S.", "authorised_date": "2019-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal 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"product_name": "Isturisa 5 mg film-coated tablets", "holder": "Recordati Rare Diseases", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H02CA", "H02CA02" ], "active_substances": [ "Osilodrostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1407/003", "product_name": "Isturisa 10 mg film-coated tablets", "holder": "Recordati Rare Diseases", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H02CA", "H02CA02" ], "active_substances": [ "Osilodrostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1408/001-005", "product_name": "Sunosi 75 mg film-coated tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "2020-01-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06BA14" ], "active_substances": [ "Solriamfetol Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1408/006-010", "product_name": "Sunosi 150 mg film-coated tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "2020-01-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06BA14", "N07" ], "active_substances": [ "Solriamfetol Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1409/001", "product_name": "Cegfila 6 mg solution for injection in pre-filled syringe", "holder": "Mundipharma Corporation (Ireland) Limited", "authorised_date": "2019-12-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "M05BX", "M05BX06" ], "active_substances": [ "ROMOSOZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1411/003-004", "product_name": "EVENITY 105 mg solution for injection in pre-filled syringe", "holder": "UCB Pharma S.A.", "authorised_date": "2019-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX", "M05BX06" ], "active_substances": [ "ROMOSOZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1412/001-004", "product_name": "Deferasirox Accord 90 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AC03" ], "active_substances": [ "Deferasirox" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1412/005-008", "product_name": "Deferasirox Accord 180 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AC03" ], "active_substances": [ "Deferasirox" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1412/009-012", "product_name": "Deferasirox Accord 360 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AC03" ], "active_substances": [ "Deferasirox" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1413/001", "product_name": "Azacitidine Accord 25 mg/mL powder for suspension for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1413/002", "product_name": "Azacitidine Accord 25 mg/mL powder for suspension for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1413/003-010", "product_name": "Azacitidine Accord 200 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1413/011-018", "product_name": "Azacitidine Accord 300 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1414/001-002", "product_name": "Mayzent 0.25 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2020-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA42" ], "active_substances": [ "Siponomid", "SIPONIMOD FUMARIC ACID" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1414/003", "product_name": "Mayzent 2 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2020-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA42" ], "active_substances": [ "Siponomid", "SIPONIMOD FUMARIC ACID" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1414/007-008", "product_name": "Mayzent 1 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2022-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA42" ], "active_substances": [ "SIPONIMOD FUMARIC ACID" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1415/001", "product_name": "Amsparity 20 mg solution for injection in pre-filled syringe", "holder": "Pfizer Service Company BVBA", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1415/002", "product_name": "Amsparity 40 mg/0.8 ml solution for injection", "holder": "Pfizer Service Company BVBA", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1415/003-006", "product_name": "Amsparity 40 mg solution for injection in pre-filled syringe", "holder": "Pfizer Service Company BVBA", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1415/007-010", "product_name": "Amsparity 40 mg solution for injection in pre-filled pen", "holder": "Pfizer Service Company BVBA", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1416/001", "product_name": "Azacitidine betapharm 25 mg/mL powder for suspension for injection", "holder": "Betapharm Arzneimittel GmbH", "authorised_date": "2020-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1417/001-002", "product_name": "Beovu 120 mg/ml solution for injection in pre-filled syringe", "holder": "Novartis Europharm Limited", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA06" ], "active_substances": [ "Brolucizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1419/001", "product_name": "Trepulmix 1 mg/ml solution for infusion", "holder": "Scipharm S.à.r.l.", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1419/002", "product_name": "Trepulmix 2.5 mg/ml 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be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1419/004", "product_name": "Trepulmix 10 mg/ml solution for infusion", "holder": "Scipharm S.à.r.l.", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/19/1420/001", "product_name": "Recarbrio 500 mg/500 mg/250 mg powder for solution for infusion", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2020-02-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01DH56" ], "active_substances": [ "Imipenem", "Cilastatin", "Relebactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1422/001-012", "product_name": "Lyumjev", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2020-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1422/013-015", "product_name": "200 units/mL KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2020-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1422/016-017", "product_name": "100 units/mL Tempo Pen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1423/001", "product_name": "Vaxchora, Effervescent powder and powder for oral suspension", "holder": "Bavarian Nordic A/S", "authorised_date": "2020-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Effervescent powder and suspension for oral suspension", "atc_codes": [ "J07AE02" ], "active_substances": [ "V.Chloerae CVD 103-HGR" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1424/001-006", "product_name": "Nustendi 180 mg/10 mg film-coated tablets", "holder": "Daiichi Sankyo Europe GmbH", "authorised_date": "2020-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XC38" ], "active_substances": [ "Bempedoic Acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1425/001-006", "product_name": "Nilemdo 180 mg film-coated tablets", "holder": "Daiichi Sankyo Europe GmbH", "authorised_date": "2020-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AX15" ], "active_substances": [ "Bempedoic Acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1426/001-002", "product_name": "Azacitidine Mylan 25 mg/mL powder for suspension for injection", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1428/001", "product_name": "Givlaari 189 mg/mL solution for injection", "holder": "Alnylam Netherlands B.V.", "authorised_date": "2020-03-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A16AX16" ], "active_substances": [ "Givosiran Sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1429/001-004", "product_name": "Cinacalcet Accordpharma 30 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05BX01" ], "active_substances": [ "Cinacalcet hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05BX01" ], "active_substances": [ "Cinacalcet hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1430/001-004", "product_name": "Rybelsus 3 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1430/005-007", "product_name": "Rybelsus 7 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1430/008-010", "product_name": "Rybelsus 14 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1430/026-030", "product_name": "Rybelsus 9 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2024-08-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1430/031-035", "product_name": "Rybelsus 25 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1430/036-040", "product_name": "Rybelsus 50 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1431/001", "product_name": "Ruxience 100 mg concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1431/002", "product_name": "Ruxience 500 mg concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC02" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1432/001", "product_name": "NUBEQA 300 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2020-03-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB06" ], "active_substances": [ "Darolutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1434/001", "product_name": "Fetcroja 1 g powder for concentrate for solution for infusion", "holder": "Shionogi B.V.", "authorised_date": "2020-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01DI04" ], "active_substances": [ "Cefiderocol Sulfate Tosilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1435/001-003", "product_name": "SARCLISA 20 mg/mL concentrate for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2020-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC38" ], "active_substances": [ "Isatuximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1436/001-002", "product_name": "Nepexto 25 mg solution for injection in pre-filled syringe", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2020-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1436/003-004", "product_name": "Nepexto 50 mg solution for injection in 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"Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1437/001-005", "product_name": "Dovprela 200 mg tablets", "holder": "Mylan IRE Healthcare Limited", "authorised_date": "2020-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J04" ], "active_substances": [ "Pretomanid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1438/001-005", "product_name": "Enerzair Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation 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"active_substances": [ "Indacaterol acetate", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1439/005-008", "product_name": "Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2020-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AK14" ], "active_substances": [ "Indacaterol acetate", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1439/009-012", "product_name": "Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2020-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AK14" ], "active_substances": [ "Indacaterol acetate", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1440/001-05", "product_name": "Zimbus Breezhaler 114 micrograms/46 micrograms/136 micrograms inhalation powder, hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2020-07-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AL12" ], "active_substances": [ "Indacaterol acetate", "Glycopyrronium bromide", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1441/001-004", "product_name": "Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2020-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AK14" ], "active_substances": [ "Indacaterol acetate", "Indacaterol", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1441/005-008", "product_name": "Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2020-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AK14" ], "active_substances": [ "Indacaterol acetate", "Indacaterol", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1441/009-012", "product_name": "Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2020-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AK14" ], "active_substances": [ "Indacaterol acetate", "Indacaterol", "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1442/001", "product_name": "Zeposia 0.23 mg hard capsules Zeposia 0.46 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2020-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AA38" ], "active_substances": [ "OZANIMOD" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1442/002-003", "product_name": "Zeposia 0.92 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2020-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AA38" ], "active_substances": [ "OZANIMOD" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1443/001-0037", "product_name": "Zolgensma 2 x 1013 vector genomes/mL solution for infusion", "holder": "Novartis Europharm Limited", "authorised_date": "2020-05-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "M09AX", "M09AX09" ], "active_substances": [ "Onasemnogene Abeparvovec" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1446/001", "product_name": "HEPCLUDEX 2 mg powder for solution for injection", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2020-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J05A", "J05AX", "J05AX28" ], "active_substances": [ "Bulevirtide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1447/001-005", "product_name": "Insulin aspart Sanofi", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1447/001-007", "product_name": "Insulin aspart Sanofi", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2021-04-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1448/001", "product_name": "Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-08-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CD04" ], "active_substances": [ "Cabazitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1450/001-006", "product_name": "Fingolimod Accord 0.5 mg hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "FINGOLIMOD HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1451/001-002", "product_name": "Daurismo 25 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX63" ], "active_substances": [ "Glasdegib Maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1451/003-004", "product_name": "Daurismo 100 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX63" ], "active_substances": [ "Glasdegib Maleate" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1452/001", "product_name": "Reblozyl 25 mg powder for solution for injection", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "B03XA06" ], "active_substances": [ "Luspatercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1452/002", "product_name": "Reblozyl 75 mg powder for solution for injection", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2020-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "B03XA06" ], "active_substances": [ "Luspatercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1453/007", "product_name": "BYANNLI 700 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Janssen-Cilag International NV", "authorised_date": "2021-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1453/008", "product_name": "BYANNLI 1 000 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Janssen-Cilag International NV", "authorised_date": "2021-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1454/001", "product_name": "Aybintio 25 mg/ml concentrate for solution for infusion", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2020-08-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC07" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1454/002", "product_name": "Aybintio 25 mg/ml concentrate for solution for infusion", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2020-08-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC07" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1455/001-003", "product_name": "Piqray 150 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2020-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX65" ], "active_substances": [ "Alpelisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1455/004-006", "product_name": "Piqray 50 mg film-coated tablets Piqray 200 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2020-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX65" ], "active_substances": [ "Alpelisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1455/007-009", "product_name": "Piqray 200 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2020-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX65" ], "active_substances": [ "Alpelisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1456/001", "product_name": "Zercepac 150 mg Powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1456/002", "product_name": "Zercepac 60 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate and solution for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1456/003", "product_name": "Zercepac 420 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1457/001", "product_name": "Xenleta 150 mg concentrate for solution for infusion", "holder": "Nabriva Therapeutics Ireland Designated Activity 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1459/001", "product_name": "Veklury 100 mg powder for concentrate for solution for infusion", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2020-07-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J05AB16" ], "active_substances": [ "Remdesivir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1460/001", "product_name": "Rozlytrek 100 mg hard capsules", "holder": "Roche Registration GmbH", "authorised_date": "2020-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX14" ], "active_substances": [ "Entrectinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1460/002", "product_name": "Rozlytrek 200 mg hard capsules", "holder": "Roche Registration GmbH", "authorised_date": "2020-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX14" ], "active_substances": [ "Entrectinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1460/003", "product_name": "Rozlytrek 50 mg film-coated granules in sachet", "holder": "Roche Registration GmbH", "authorised_date": "2024-06-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated granules", "atc_codes": [ "L01EX14" ], "active_substances": [ "Entrectinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1462/001-002", "product_name": "Livogiva 20 micrograms/80 microliters solution for injection in pre-filled pen", "holder": "Theramex Ireland Limited", "authorised_date": "2020-08-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1465/001", "product_name": "Gencebok 10 mg/ml solution for infusion", "holder": "Gennisium Pharma", "authorised_date": "2020-08-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N06BC01" ], "active_substances": [ "Caffeine", "Caffeine citrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription 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"2020-08-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX32" ], "active_substances": [ "Ivacaftor", "TEZACAFTOR", "Elexacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1468/003", "product_name": "Kaftrio 60 mg/40 mg/80 mg granules in sachet", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2023-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules in sachet", "atc_codes": [ "R07AX32" ], "active_substances": [ "Elexacaftor", "TEZACAFTOR", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1468/004", "product_name": "Kaftrio 75 mg/50 mg/100 mg granules in sachet", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2023-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules in sachet", "atc_codes": [ "R07AX32" ], "active_substances": [ "Elexacaftor", "TEZACAFTOR", "Ivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1469/001", "product_name": "ARIKAYCE liposomal 590 mg nebuliser dispersion", "holder": "Insmed Netherlands B.V.", "authorised_date": "2020-10-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nebuliser dispersion", "atc_codes": [ "J01GB06" ], "active_substances": [ "AMIKACIN SULFATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1470/001", "product_name": "Lumeblue 25 mg prolonged-release tablets", "holder": "Alfasigma S.p.A", "authorised_date": "2020-08-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "V04CX" ], "active_substances": [ "Methylthioninium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 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"L01EX18", "L01XE" ], "active_substances": [ "Avapritinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1473/002", "product_name": "AYVAKYT 200 mg film-coated tablets", "holder": "Blueprint Medicines (Netherlands) B.V.", "authorised_date": "2020-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX18", "L01XE" ], "active_substances": [ "Avapritinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1473/003", "product_name": "AYVAKYT 300 mg 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not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1473/005", "product_name": "AYVAKYT 50 mg film-coated tablets", "holder": "Blueprint Medicines (Netherlands) B.V.", "authorised_date": "2022-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX18" ], "active_substances": [ "Avapritinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1475/001", "product_name": "Arsenic trioxide medac 1 mg/ml concentrate for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2020-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX27" ], "active_substances": [ "Arsenic trioxide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1477/001-002", "product_name": "Fampridine Accord 10 mg prolonged-release tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX07" ], "active_substances": [ "Fampridine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1479/001-002", "product_name": "Calquence 100 mg hard capsules", "holder": "AstraZeneca AB", "authorised_date": "2020-11-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE51" ], "active_substances": [ "Acalabrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1479/001-004", "product_name": "Calquence film-coated tablets", "holder": "AstraZeneca AB", "authorised_date": "2023-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01", "L01EL02" ], "active_substances": [ "Acalabrutinib maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1480/001-002", "product_name": "Jyseleca 100 mg film-coated tablets", "holder": "Alfasigma S.p.A", "authorised_date": "2020-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA45" ], "active_substances": [ "Filgotinib maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1480/003-004", "product_name": "Jyseleca 200 mg film-coated 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1481/002", "product_name": "Vocabria 400 mg prolonged-release suspension for injection", "holder": "ViiV Healthcare BV", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "J05AJ04" ], "active_substances": [ "cabotegravir" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1481/003", "product_name": "Vocabria 600 mg prolonged-release suspension for injection", "holder": "ViiV Healthcare BV", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "J05AJ04", "J05AX" ], "active_substances": [ "cabotegravir" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1482/001", "product_name": "REKAMBYS 600 mg prolonged-release suspension for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "J05AG05" ], "active_substances": [ "Rilpivirine" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"dosage_form": "Solution for injection", "atc_codes": [ "J07AH08" ], "active_substances": [ "Neisseria Meningitidis Group A Polysaccharide", "Neisseria Meningitis Group W135 Polysaccharide", "N. 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1488/039", "product_name": "Rivaroxaban Accord 15 mg film-coated tablets Rivaroxaban Accord 20 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1488/040-053", "product_name": "Rivaroxaban Accord 20 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2020-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1489/001-004", "product_name": "EXPAREL liposomal", "holder": "Pacira Ireland Limited", "authorised_date": "2020-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release dispersion for injection", "atc_codes": [ "N01BB01" ], "active_substances": [ "Bupivacaine" ], "routes": [ "Infiltration", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1490/001-003", "product_name": "Lenalidomide Mylan 2.5 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1490/004-005", "product_name": "Lenalidomide Mylan 5 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1490/006-008", "product_name": "Lenalidomide Mylan 7.5 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1490/009-010", "product_name": "Lenalidomide Mylan 10 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1490/011-012", "product_name": "Lenalidomide Mylan 15 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1490/016-018", "product_name": "Lenalidomide Mylan 25 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1491/001-004", "product_name": "Fintepla 2.2 mg/ml oral solution", "holder": "UCB Pharma S.A.", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX", "N03AX26" ], "active_substances": [ "Fenfluramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1492/001", "product_name": "Tecartus 0.4 – 2 × 108 cells dispersion for infusion", "holder": "Kite Pharma EU B.V.", "authorised_date": "2020-12-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01XL06" ], "active_substances": [ "Autologous Peripheral Blood T Cells CD4 and CD8 selected and CD3 and CD28 Activated 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"holder": "STALLERGENES", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in capsules for opening", "atc_codes": [ "V01AA08" ], "active_substances": [ "Arachis Hypogaea Allergens" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1495/002-003", "product_name": "Palforzia 1 mg oral powder in capsules for opening", "holder": "STALLERGENES", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in capsules for opening", "atc_codes": [ "V01AA08" ], "active_substances": [ "Arachis Hypogaea Allergens" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1495/004", "product_name": "Palforzia 10 mg oral powder in capsules for opening Palforzia 1 mg oral powder in capsules for opening", "holder": "STALLERGENES", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in capsules for opening", "atc_codes": [ "V01AA08" ], "active_substances": [ "Arachis Hypogaea Allergens" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1495/011", "product_name": "Palforzia 100 mg oral powder in capsules for opening", "holder": "STALLERGENES", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in capsules for opening", "atc_codes": [ "V01AA08" ], "active_substances": [ "Arachis Hypogaea Allergens" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1495/012-013", "product_name": "Palforzia 300 mg oral powder in sachet", "holder": "STALLERGENES", "authorised_date": "2020-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in sachet", "atc_codes": [ "V01AA08" ], "active_substances": [ "Arachis Hypogaea Allergens" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1496/001", "product_name": "Oxlumo 94.5 mg/0.5 mL solution for injection", "holder": "Alnylam Netherlands B.V.", "authorised_date": "2020-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A16AX" ], "active_substances": [ "Lumasiran sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1497/001", "product_name": "Phesgo 1200 mg/600 mg solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2020-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01", "L01XY02" ], "active_substances": [ "Pertuzumab", "Trastuzumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1497/002", "product_name": "Phesgo 600 mg/600 mg solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2020-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01", "L01XY02" ], "active_substances": [ "Pertuzumab", "Trastuzumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1498/002-003", "product_name": "Trixeo Aerosphere 5/7.2/160 micrograms pressurised inhalation, suspension", "holder": "AstraZeneca AB", "authorised_date": "2020-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AL11" ], "active_substances": [ "Budesonide micronised", "Glycopyrronium bromide", "Formoterol fumarate dihydrate (micronised)" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1500/001", "product_name": "Xofluza 20 mg film-coated tablets", "holder": "Roche Registration GmbH", "authorised_date": "2021-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX25" ], "active_substances": [ "Baloxavir Marboxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1500/002", "product_name": "Xofluza 40 mg film-coated tablets", "holder": "Roche Registration GmbH", "authorised_date": "2021-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [ "Baloxavir Marboxil" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1500/003", "product_name": "Xofluza 80 mg film-coated tablets", "holder": "Roche Registration GmbH", "authorised_date": "2021-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX25" ], "active_substances": [ "Baloxavir Marboxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1500/005", "product_name": "Xofluza 2 mg/mL granules for oral suspension", "holder": "Roche Registration GmbH", "authorised_date": "2021-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J05AX25" ], "active_substances": [ "Baloxavir Marboxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1501/001-002", "product_name": "Sogroya 10 mg/1.5 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2021-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC", "H01AC07" ], "active_substances": [ "Somapacitan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1501/003-004", "product_name": "Sogroya 5 mg/1.5 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2022-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC07" ], "active_substances": [ "Somapacitan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1501/005-006", "product_name": "Sogroya 15 mg/1.5 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2023-07-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC07" ], "active_substances": [ "Somapacitan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J07BC01" ], "active_substances": [ "Hepatitis b surface antigen" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1504/001", "product_name": "ELZONRIS 1 mg/mL concentrate for solution for infusion", "holder": "TMC Pharma (EU) Limited", "authorised_date": "2021-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01X", "L01XX67" ], "active_substances": [ "Tagraxofusp" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1505/001", "product_name": "Byfavo 20 mg powder for solution for injection", "holder": "Paion Pharma GmbH", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "N05CD" ], "active_substances": [ "Remimazolam besilate", "Remimazolam (in house)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1505/002", "product_name": "Byfavo 50 mg powder for concentrate for solution for injection/infusion", "holder": "Paion Pharma GmbH", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N05CD14" ], "active_substances": [ "Remimazolam besilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1506/001-007", "product_name": "Kirsty", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2021-02-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological 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"atc_codes": [ "J07BN01" ], "active_substances": [ "Elasomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1507/003", "product_name": "Spikevax 50 micrograms dispersion for injection in pre-filled syringe", "holder": "Moderna Biotech Spain S.L.", "authorised_date": "2022-08-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for injection", "atc_codes": [ "J07BN01" ], "active_substances": [ "Elasomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1507/004-005", "product_name": "Spikevax bivalent Original/Omicron BA.1", "holder": "Moderna Biotech Spain S.L.", "authorised_date": "2022-08-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for injection", "atc_codes": [ "J07BN01" ], "active_substances": [ "Elasomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1507/006", "product_name": "Spikevax bivalent Original/Omicron BA4-5", "holder": "Moderna Biotech Spain S.L.", "authorised_date": "2022-10-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for injection", "atc_codes": [ "J07BN01" ], "active_substances": [ "Elasomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1507/007-008", "product_name": "Spikevax bivalent Original/Omicron BA.1", "holder": "Moderna Biotech Spain S.L.", "authorised_date": "2022-10-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for injection", "atc_codes": [ "J07BN01" ], "active_substances": [ "Elasomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1507/027-030", "product_name": "Spikevax XBB.1.5 25 micrograms dispersion for injection in pre-filled syringe. COVID-19 mRNA Vaccine", "holder": "Moderna Biotech Spain S.L.", "authorised_date": "2025-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for injection in pre-filled syringe", "atc_codes": [ "J07BN01" ], "active_substances": [ "Andusomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1508/001", "product_name": "Enhertu 100 mg powder for concentrate for solution for infusion", "holder": "Daiichi Sankyo Europe GmbH", "authorised_date": "2021-01-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC41" ], "active_substances": [ "Trastuzumab Deruxtecan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1509/001-002", "product_name": "Alymsys 25 mg/mL concentrate for solution for infusion", "holder": "Mabxience Research, S.L.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC07" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1510/001-002", "product_name": "Oyavas 25 mg/mL concentrate for 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"registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE04" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1511/010-012", "product_name": "Sunitinib Accord 50 mg hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2021-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE04" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1512/001", "product_name": "Abiraterone Accord 250 mg tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2021-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1512/002-003", "product_name": "Abiraterone Accord 500 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2021-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1513/001-012", "product_name": "Yuflyma", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2021-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1513/013-016", "product_name": "Yuflyma", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2022-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1513/017", "product_name": "Yuflyma 20 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1514/001", "product_name": "INREBIC 100 mg hard capsules", "holder": "Bristol-Myers Squibb Pharmaceuticals uc", "authorised_date": "2021-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE" ], "active_substances": [ "Fedratinib dihydrochloride monohydrate", "Fedratinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1515/001-005", "product_name": "Abevmy 25 mg/mL concentrate for solution for infusion", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2021-04-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC07" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1517/001-006", "product_name": "Sibnayal 8 mEq prolonged-release granules", "holder": "Advicenne Pharma SA", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A12BA30" ], "active_substances": [ "Potassium citrate", "Potassium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1517/007-012", "product_name": "Sibnayal 24 mEq prolonged-release granules", "holder": "Advicenne Pharma SA", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A12BA30" ], "active_substances": [ "Potassium citrate", "Potassium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1518/001", "product_name": "Rukobia 600 mg prolonged-release tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2021-02-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": 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}, { "licence_number": "EU/1/20/1519/003-004", "product_name": "Lenalidomide Krka 5 mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2021-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide hydrochloride hydrate", "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1519/005-006", "product_name": "Lenalidomide Krka 7.5 mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2021-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide hydrochloride 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H04AA01" ], "active_substances": [ "GLUCAGON" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1524/001-002", "product_name": "Vazkepa 998 mg soft capsules", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "C10AX", "C10AX06" ], "active_substances": [ "Icosapent ethyl" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"2021-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX22" ], "active_substances": [ "Selpercatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/20/1527/012-014", "product_name": "Retsevmo 40 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2025-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX22" ], "active_substances": [ "Selpercatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application 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"Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01XC10", "L04AA" ], "active_substances": [ "Ofatumumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1533/001-002", "product_name": "Seffalair Spiromax 12.75 micrograms/100 micrograms inhalation powder", "holder": "Teva B.V.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1533/003-004", "product_name": "Seffalair Spiromax 12.75 micrograms/202 micrograms inhalation powder", "holder": "Teva B.V.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1535/001-002", "product_name": "Pemazyre 4.5 mg tablets", "holder": "Incyte Biosciences Distribution B.V.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01EN02" ], "active_substances": [ "Pemigatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1535/003-004", "product_name": "Pemazyre 9 mg tablets", "holder": "Incyte Biosciences Distribution B.V.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01EN02" ], "active_substances": [ "Pemigatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1535/005-006", "product_name": "Pemazyre 13.5 mg tablets", "holder": "Incyte Biosciences Distribution B.V.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01EN02" ], "active_substances": [ "Pemigatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1536/001", "product_name": "Thiotepa Riemser 15 mg powder for concentrate for solution for infusion", "holder": "Esteve Pharmaceuticals GmbH", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AC01" ], "active_substances": [ "Thiotepa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1536/002", "product_name": "Thiotepa Riemser 100 mg powder for concentrate for solution for infusion", "holder": "Esteve Pharmaceuticals GmbH", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AC01" ], "active_substances": [ "Thiotepa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1537/001-004", "product_name": "NEXPOVIO 20 mg film-coated tablets", "holder": "Karyopharm Europe GmbH", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX66" ], "active_substances": [ "Selinexor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1538/001", "product_name": "JEMPERLI 500 mg concentrate for solution for infusion", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2021-04-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC40" ], "active_substances": [ "Dostarlimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1539/001", "product_name": "Abecma 260 - 500 x 106 cells dispersion for infusion", "holder": "Bristol-Myers Squibb Pharmaceuticals uc", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01" ], "active_substances": [ "Idecabtagene Vicleucel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1544/001", "product_name": "Orladeyo 150 mg hard capsules", "holder": "BioCryst Ireland Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B06AC06" ], "active_substances": [ "Berotralstat hydrochloride", "Berotralstat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1546/001", "product_name": "Ozawade 4.5 mg film-coated tablets", "holder": "Bioprojet Pharma", "authorised_date": "2021-07-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07XX11" ], "active_substances": [ "Pitolisant hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1546/002-003", "product_name": "Ozawade 18 mg film-coated tablets", "holder": "Bioprojet Pharma", "authorised_date": "2021-07-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07XX11" ], "active_substances": [ "Pitolisant hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1547/001-004", "product_name": "Drovelis 3 mg/14.2 mg film-coated tablets", "holder": "Chemical Works Of Gedeon Richter PLC", "authorised_date": "2021-05-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA18" ], "active_substances": [ "Drospirenone", "Estetrol", "Estetrol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1548/001-004", "product_name": "Lydisilka 3 mg/14.2 mg film-coated tablets", "holder": "Estetra", "authorised_date": "2021-05-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA18" ], "active_substances": [ "Estetrol monohydrate", "Estetrol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1549/001", "product_name": "Efmody 5 mg modified-release hard capsules", "holder": "Immedica Pharma AB", "authorised_date": "2021-05-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1549/002", "product_name": "Efmody 10 mg modified-release hard capsules", "holder": "Immedica Pharma AB", "authorised_date": "2021-05-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1549/003", "product_name": "Efmody", "holder": "Diurnal Europe B.V.", "authorised_date": "2021-05-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1550/001", "product_name": "Ponvory 2 mg+3 mg+4 mg+5 mg+6 mg+7 mg+8 mg+9 mg+10 mg film-coated tablets", "holder": "Laboratoires Juvise Pharmaceuticals", "authorised_date": "2021-05-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA50" ], "active_substances": [ "Ponesimod" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1550/002", "product_name": "Ponvory 20 mg film-coated tablets", "holder": "Laboratoires Juvise Pharmaceuticals", "authorised_date": "2021-05-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA50" ], "active_substances": [ "Ponesimod" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1551/001-002", "product_name": "Evkeeza 150 mg/ml concentrate for solution for infusion", "holder": "Ultragenyx Germany GmbH", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C10AX" ], "active_substances": [ "Evinacumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1552/001", "product_name": "Koselugo 10 mg hard capsules", "holder": "AstraZeneca AB", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EE04", "L01XE" ], "active_substances": [ "Selumetinib Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1552/002", "product_name": "Koselugo 25 mg hard capsules", "holder": "AstraZeneca AB", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EE04", "L01XE" ], "active_substances": [ "Selumetinib Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1552/003", "product_name": "Koselugo 5 mg granules in capsule for opening", "holder": "AstraZeneca AB", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules in capsule for opening", "atc_codes": [ "L01EE04" ], "active_substances": [ "Selumetinib Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1552/004", "product_name": "Koselugo 7.5 mg granules in capsule for opening", "holder": "AstraZeneca AB", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules in capsule for opening", "atc_codes": [ "L01EE04" ], "active_substances": [ "Selumetinib Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1553/001-003", "product_name": "Abiraterone Krka 500 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2021-06-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1554/001-003", "product_name": "Adtralza 150 mg solution for injection in pre-filled syringe", "holder": "LEO Pharma A/S", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "D11AH07" ], "active_substances": [ "Tralokinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1554/004-005", "product_name": "Adtralza 300 mg solution for injection in pre-filled pen", "holder": "LEO Pharma A/S", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "D11AH07" ], "active_substances": [ "Tralokinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1556/001-002", "product_name": "Onureg 200 mg film-coated tablets", "holder": "Celgene Europe B.V.", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1556/003-004", "product_name": "Onureg 300 mg film-coated tablets", "holder": "Celgene Europe B.V.", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1557/001", "product_name": "Jayempi 10 mg/ml oral suspension", "holder": "Lipomed GmbH", "authorised_date": "2021-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1558/001", "product_name": "Klisyri 10 mg/g ointment", "holder": "Almirall, S.A.", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D06BX03" ], "active_substances": [ "Tirbanibulin" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1559/001", "product_name": "Enspryng 120 mg solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "2021-06-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AA", "L04AC19" ], "active_substances": [ "Satralizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1560/001-002", "product_name": "Celsunax 74 MBq/mL solution for injection", "holder": "Pinax Pharma GmbH", "authorised_date": "2021-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AB03" ], "active_substances": [ "Ioflupane (123I)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1561/001-011", "product_name": "Verquvo 2.5 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01", "C01DX22" ], "active_substances": [ "Vericiguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1561/012-022", "product_name": "Verquvo 5 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01", "C01DX22" ], "active_substances": [ "Vericiguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1561/023-025", "product_name": "Verquvo 10 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01", "C01DX22" ], "active_substances": [ "Vericiguat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1564/001", "product_name": "IMCIVREE 10 mg/ml solution for injection", "holder": "Rhythm Pharmaceuticals Netherlands B.V", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A08AA" ], "active_substances": [ "Setmelanotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1565/001-002", "product_name": "Ryeqo 40 mg/1 mg/0.5 mg film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H01C", "H01CC54" ], "active_substances": [ "Relugolix", "Estradiol hemihydrate", "Norethisterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1566/001", "product_name": "Bylvay 200 micrograms hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1566/002", "product_name": "Bylvay 400 micrograms hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1566/003", "product_name": "Bylvay 600 micrograms hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1566/004", "product_name": "Bylvay 1 200 micrograms hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1567/001-002", "product_name": "Icatibant Accord 30 mg solution for injection in pre-filled syringe", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion in pre-filled syringe", "atc_codes": [ "B06AC02" ], "active_substances": [ "Icatibant" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1569/001-002", "product_name": "QINLOCK 50 mg tablets", "holder": "Deciphera Pharmaceuticals (Netherlands) B.V.", "authorised_date": "2021-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01", "L01EX19" ], "active_substances": [ "Ripretinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1570/001", "product_name": "MINJUVI 200 mg powder for concentrate for solution for infusion", "holder": "Incyte Biosciences Distribution B.V.", "authorised_date": "2021-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XC", "L01XC35" ], "active_substances": [ "Tafasitamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1571/001-008", "product_name": "Abiraterone Mylan 500 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2021-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1571/009-012", "product_name": "Abiraterone Mylan 1000 mg film-coated tablets", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2021-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1572/001", "product_name": "Byooviz 10 mg/ml solution for injection", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA04" ], "active_substances": [ "Ranibizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1573/001-024", "product_name": "Fingolimod Mylan 0.5 mg hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "FINGOLIMOD HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1574/001", "product_name": "Evrenzo 20 mg Film-coated tablet", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA05" ], "active_substances": [ "Roxadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1574/002", "product_name": "Evrenzo 50 mg Film-coated tablet", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA05" ], "active_substances": [ "Roxadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1574/003", "product_name": "Evrenzo 70 mg Film-coated tablet", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA05" ], "active_substances": [ "Roxadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1574/004", "product_name": "Evrenzo 100 mg Film-coated tablet", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA05" ], "active_substances": [ "Roxadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1574/005", "product_name": "Evrenzo 150 mg Film-coated tablet", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2021-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA05" ], "active_substances": [ "Roxadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1575/001-004", "product_name": "Bimzelx 160 mg solution for injection in pre-filled syringe", "holder": "UCB Pharma S.A.", "authorised_date": "2021-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC21" ], "active_substances": [ "Bimekizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1575/005-008", "product_name": "Bimzelx 160 mg solution for injection in pre-filled pen", "holder": "UCB Pharma S.A.", "authorised_date": "2021-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC21" ], "active_substances": [ "Bimekizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1575/009-010", "product_name": "Bimzelx 320 mg solution for injection in pre-filled syringe", "holder": "UCB Biopharma SPRL", "authorised_date": "2021-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC21" ], "active_substances": [ "Bimekizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1575/011-012", "product_name": "Bimzelx 320 mg solution for injection in pre-filled pen", "holder": "UCB Biopharma SPRL", "authorised_date": "2021-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC21" ], "active_substances": [ "Bimekizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1576/001", "product_name": "BRUKINSA 80 mg hard capsules", "holder": "BeiGene Ireland Limited", "authorised_date": "2021-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01", "L01EL03" ], "active_substances": [ "Zanubrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1576/002", "product_name": "BRUKINSA 160 mg film-coated tablets", "holder": "BeiGene Ireland Limited", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EL03" ], "active_substances": [ "Zanubrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1577/001", "product_name": "Voxzogo 0.4 mg powder and solvent for solution for injection", "holder": "Biomarin International Limited", "authorised_date": "2021-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "M05BX", "M05BX07" ], "active_substances": [ "Vosoritide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1577/002", "product_name": "Voxzogo 0.56 mg powder and solvent for solution for injection", "holder": "Biomarin International Limited", "authorised_date": "2021-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "M05BX07" ], "active_substances": [ "Vosoritide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1577/003", "product_name": "Voxzogo 1.2 mg Powder and solvent for solution for injection", "holder": "Biomarin International Limited", "authorised_date": "2021-08-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "M05BX07" ], "active_substances": [ "Vosoritide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1579/001-004", "product_name": "Nexviadyme 100 mg powder for concentrate for solution for infusion", "holder": "Sanofi B.V.", "authorised_date": "2022-06-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "A16AB22" ], "active_substances": [ "Avalglucosidase Alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1582/001-002", "product_name": "Artesunate Amivas 110 mg solvent for solution for injection", "holder": "Amivas Ireland Limited", "authorised_date": "2021-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "P01BE03" ], "active_substances": [ "Artesunate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1583/001-004", "product_name": "Sugammadex Mylan 100 mg/mL solution for injection", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2021-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1585/001-002", "product_name": "Vumerity 231 mg gastro-resistant hard capsules", "holder": "Biogen Netherlands B.V.", "authorised_date": "2021-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX", "L04AX09" ], "active_substances": [ "Diroximel Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1586/001", "product_name": "Voraxaze 1,000 units powder for solution for injection", "holder": "Serb S.A.S.", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "V03AF09" ], "active_substances": [ "Glucarpidase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1587/001-010", "product_name": "RAYVOW 50 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC08" ], "active_substances": [ "Lasmiditan Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1587/011-020", "product_name": "RAYVOW 100 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC08" ], "active_substances": [ "Lasmiditan Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1587/021-030", "product_name": "RAYVOW 200 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC08" ], "active_substances": [ "Lasmiditan Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1588/001-014", "product_name": "Rivaroxaban Viatris 2.5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1588/015-025", "product_name": "Rivaroxaban Viatris 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1588/026-040", "product_name": "Rivaroxaban Viatris 15 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1588/041-054", "product_name": "Rivaroxaban Viatris 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1588/055", "product_name": "Rivaroxaban Viatris 15 mg film-coated tablets Rivaroxaban Viatris 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1589/001-003", "product_name": "Hukyndra 40 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2021-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1589/004-006", "product_name": "Hukyndra 40 mg solution for injection in pre-filled pen", "holder": "Stada Arzneimittel AG", "authorised_date": "2021-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1589/007", "product_name": "Hukyndra 80 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2021-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1589/008-009", "product_name": "Hukyndra 80 mg solution for injection in pre-filled pen", "holder": "Stada Arzneimittel AG", "authorised_date": "2021-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1589/010", "product_name": "Hukyndra 20 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1590/001-006", "product_name": "Libmyris", "holder": "Stada Arzneimittel AG", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1590/007", "product_name": "Libmyris 80 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB04" ], "active_substances": [ "Adalimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1591/001-006", "product_name": "Vaxneuvance suspension for injection in pre-filled syringe", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2021-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AL" ], "active_substances": [ "Pneumococcal Polysaccharide Serotype 1 Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 3 Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 4 Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 5 Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 6A Conjugated to CRM197", "Pneumococcal polysaccharide serotype 7f", "Pneumococcal Polysaccharide Serotype 9V Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 14 Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 18C Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 19A Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 19F Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 22F Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 23F Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 33F Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 6B Conjugated to CRM197" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1592/001", "product_name": "Trodelvy 200 mg powder for concentrate for solution for infusion", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2021-11-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX17" ], "active_substances": [ "Sacituzumab Govitecan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1593/001-005", "product_name": "Cibinqo 50 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "D11AH", "D11AH08" ], "active_substances": [ "Abrocitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1593/006-010", "product_name": "Cibinqo 100 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "D11AH", "D11AH08" ], "active_substances": [ "Abrocitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1593/011-015", "product_name": "Cibinqo 200 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "D11AH", "D11AH08" ], "active_substances": [ "Abrocitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1594/001", "product_name": "Rybrevant 350 mg concentrate for solution for infusion", "holder": "Janssen-Cilag International NV", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FX18" ], "active_substances": [ "Amivantamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1594/002", "product_name": "Rybrevant 1 600 mg solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01FX18" ], "active_substances": [ "Amivantamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1594/003", "product_name": "Rybrevant 2240 mg solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01FX18" ], "active_substances": [ "Amivantamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1595/001-002", "product_name": "ASPAVELI 1 080 mg solution for infusion", "holder": "Apellis Ireland Limited", "authorised_date": "2021-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "L04AA54" ], "active_substances": [ "Pegcetacoplan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1596/001", "product_name": "TEPMETKO 225 mg film-coated tablets", "holder": "Merck Europe B.V.", "authorised_date": "2022-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01", "L01EX21" ], "active_substances": [ "Tepotinib hydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1598/001-004", "product_name": "Sitagliptin SUN 25 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1598/005-008", "product_name": "Sitagliptin SUN 50 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1598/009-012", "product_name": "Sitagliptin SUN 100 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1599/001", "product_name": "VYEPTI 100 mg concentrate for solution for infusion", "holder": "H. Lundbeck A/S", "authorised_date": "2022-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N02C", "N02CD05" ], "active_substances": [ "Eptinezumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1599/003", "product_name": "VYEPTI 300 mg concentrate for solution for infusion", "holder": "H. Lundbeck A/S", "authorised_date": "2023-12-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N02CD05" ], "active_substances": [ "Eptinezumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1600/001", "product_name": "Tecovirimat SIGA 200 mg hard capsules", "holder": "SIGA Technologies Netherlands B.V.", "authorised_date": "2022-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J05AX24" ], "active_substances": [ "Tecovirimat Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1602/001", "product_name": "Uplizna 100 mg concentrate for solution for infusion", "holder": "Amgen Europe B.V.,", "authorised_date": "2022-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA47" ], "active_substances": [ "Inebilizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1603/001-003", "product_name": "LUMYKRAS 120 mg film-coated tablets", "holder": "Amgen Europe B.V.,", "authorised_date": "2022-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX73" ], "active_substances": [ "Sotorasib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1603/004", "product_name": "LUMYKRAS 240 mg film-coated tablets", "holder": "Amgen Europe B.V.,", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX73" ], "active_substances": [ "Sotorasib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1604/001-002", "product_name": "Riltrava Aerosphere 5/7.2/160 micrograms pressurised inhalation, suspension", "holder": "AstraZeneca AB", "authorised_date": "2022-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AL11" ], "active_substances": [ "Formoterol fumarate dihydrate", "Glycopyrronium bromide", "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1605/001-002", "product_name": "TAVNEOS 10 mg Capsule, hard", "holder": "Vifor Fresenius Medical Care Renal Pharma France", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AJ05" ], "active_substances": [ "Avacopan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1606/001", "product_name": "Yselty 100 mg film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2022-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H01CC04" ], "active_substances": [ "Linzagolix Choline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1606/002", "product_name": "Yselty 200 mg film-coated 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1607/002", "product_name": "Skytrofa 3.6 mg Powder and solvent for solution for injection", "holder": "Ascendis Pharma Endocrinology Division A/S", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC09" ], "active_substances": [ "Lonapegsomatropin", "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1607/003", "product_name": "Skytrofa 4.3 mg Powder and 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"active_substances": [ "Lonapegsomatropin", "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1607/005", "product_name": "Skytrofa 6.3 mg Powder and solvent for solution for injection", "holder": "Ascendis Pharma Endocrinology Division A/S", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC09" ], "active_substances": [ "Lonapegsomatropin", "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1607/006", "product_name": "Skytrofa 7.6 mg Powder and solvent for solution for injection", "holder": "Ascendis Pharma Endocrinology Division A/S", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC09" ], "active_substances": [ "Lonapegsomatropin", "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1607/007", "product_name": "Skytrofa 9.1 mg Powder and solvent for solution for injection", "holder": "Ascendis Pharma Endocrinology Division A/S", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC09" ], "active_substances": [ "Lonapegsomatropin", "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1607/008", "product_name": "Skytrofa 11 mg Powder and solvent for solution for injection", "holder": "Ascendis Pharma Endocrinology Division A/S", "authorised_date": "2022-01-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC09" ], "active_substances": [ "Lonapegsomatropin", "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/002", "product_name": "Wegovy 0.5 mg Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2022-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 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"Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/005", "product_name": "Wegovy 2.4 mg Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2022-01-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/006", "product_name": "Wegovy 0.25 mg Solution for injection", "holder": "Novo 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/008", "product_name": "Wegovy 1 mg Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2024-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/009", "product_name": "Wegovy 1.7 mg Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2024-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/010-011", "product_name": "Wegovy 2.4 mg Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2024-06-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/013-015", "product_name": "Wegovy 1.5 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2026-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/016-018", "product_name": "Wegovy 4 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2026-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/019-021", "product_name": "Wegovy 9 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2026-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/022-024", "product_name": "Wegovy 25 mg tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2026-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1608/025", "product_name": "Wegovy 7.2 mg solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2026-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ06" ], "active_substances": [ "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1611/00-004", "product_name": "Vildagliptin/Metformin hydrochloride 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[ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1612/001-006", "product_name": "Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2022-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07AL02" ], "active_substances": [ "Pneumococcal polysaccharide serotype 1", "Pneumococcal Polysaccharide Serotype 3", "Pneumococcal polysaccharide serotype 4", "Pneumococcal polysaccharide serotype 5", "Pneumococcal Polysaccharide Serotype 6A", "Pneumococcal polysaccharide serotype 7f", "Pneumococcal Polysaccharide Serotype 8", "Pneumococcal polysaccharide serotype 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"dosage_form": "Film-coated tablet", "atc_codes": [ "R05DB", "R05DB29" ], "active_substances": [ "Gefapixant" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1615/001", "product_name": "Padcev 20 mg Powder for concentrate for solution for infusion", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2022-04-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01", "L01FX13" ], "active_substances": [ "Enfortumab Vedotin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of 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"Powder for oral solution", "atc_codes": [ "A16AX07" ], "active_substances": [ "Sapropterin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1620/004", "product_name": "Sapropterin Dipharma 500 mg Powder for oral solution", "holder": "Dipharma Arzneimittel GmbH", "authorised_date": "2022-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A16AX07" ], "active_substances": [ "Sapropterin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1621/001", "product_name": "OKEDI 75 mg Powder and solvent for prolonged-release suspension for injection", "holder": "Laboratorios Farmacéuticos ROVI, S.A.", "authorised_date": "2022-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1621/002", "product_name": "OKEDI 100 mg Powder and solvent for prolonged-release suspension for injection", "holder": "Laboratorios Farmacéuticos ROVI, S.A.", "authorised_date": "2022-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1622/001", "product_name": "Oxbryta", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2022-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B06A", "B06AX03" ], "active_substances": [ "Voxelotor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1623/001", "product_name": "Saphnelo 300 mg Concentrate for solution for infusion", "holder": "AstraZeneca AB", "authorised_date": "2022-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AG11" ], "active_substances": [ "Anifrolumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1623/002", "product_name": "Saphnelo 120 mg solution for injection in pre-filled syringe", "holder": "AstraZeneca AB", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AG11" ], "active_substances": [ "Anifrolumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/21/1623/003-005", "product_name": "Saphnelo 120 mg solution for injection in pre-filled pen", "holder": "AstraZeneca AB", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AG11" ], "active_substances": [ "Anifrolumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1625/001", "product_name": "Paxlovid 150 mg + 100 mg Film-coated tablet", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2022-01-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE30" ], "active_substances": [ "PF-07321332" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1628/001-002", "product_name": "Sondelbay", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2022-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not 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"Immunocore Ireland Limited", "authorised_date": "2022-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01" ], "active_substances": [ "Tebentafusp" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1631/001", "product_name": "Breyanzi 1.1-70 x 10^6 cells/mL/1.1-70 x 10^6 cells/mL dispersion for infusion", "holder": "Celgene Europe B.V.", "authorised_date": "2022-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01" ], "active_substances": [ "Lisocabtagene Maraleucel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to 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"supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1633/011-015", "product_name": "Sitagliptin Accord 100 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2022-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin Hydrochloride Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1638/001-002", "product_name": "QUVIVIQ 25 mg film-coated tablets", "holder": "Idorsia Pharmaceuticals Deutschland GmbH", "authorised_date": "2022-04-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CJ03" ], "active_substances": [ "Daridorexant hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1638/003-004", "product_name": "QUVIVIQ 50 mg film-coated tablets", "holder": "Idorsia Pharmaceuticals Deutschland GmbH", "authorised_date": "2022-04-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CJ03" ], "active_substances": [ "Daridorexant hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) 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"EU/1/22/1648/001", "product_name": "CARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusion", "holder": "Janssen Pharmaceutica NV", "authorised_date": "2022-05-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01XL05" ], "active_substances": [ "Ciltacabtagene autoleucel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1649/001", "product_name": "Lunsumio 1 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2022-06-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FX25" ], "active_substances": [ 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(Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1652/001-002", "product_name": "Filsuvez", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2022-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D03AX", "D03AX13" ], "active_substances": [ "BETULAE CORTEX DRY EXTRACT (5-10 : 1); EXTRACTION SOLVENT: N-HEPTANE 95% (W/W)" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1653/001", "product_name": "Upstaza 2.8 × 10^11 vector genomes/0.5 mL solution for infusion", "holder": "PTC Therapeutics International Limited", "authorised_date": "2022-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "A16AB26" ], "active_substances": [ "Eladocagene Exuparvovec" ], "routes": [ "Intracerebral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1655/001-004", "product_name": "Pirfenidone axunio 267 mg film-coated tablets", "holder": "Axunio Pharma GmbH", "authorised_date": "2022-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1655/005-006", "product_name": "Pirfenidone axunio 534 mg film-coated tablets", "holder": "Axunio Pharma GmbH", "authorised_date": "2022-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1655/007-010", "product_name": "Pirfenidone Axunio 801 film-coated tablets", "holder": "Axunio Pharma GmbH", "authorised_date": "2022-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"2022-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "A07EA", "A07EA06" ], "active_substances": [ "Budesonide micronised" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1658/001-002", "product_name": "Ganirelix Gedeon Richter 0.25 mg/0.5 mL solution for injection in pre-filled syringe", "holder": "Chemical Works Of Gedeon Richter PLC", "authorised_date": "2022-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CC01" ], "active_substances": [ "Ganirelix Acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Hydrochloride Monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1662/001-003", "product_name": "Pyrukynd 5 mg film-coated tablets", "holder": "Agios Netherlands B.V.", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B06", "B06AX04" ], "active_substances": [ "Mitapivat Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1662/004-005", "product_name": "Pyrukynd", "holder": "Agios Netherlands B.V.", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B06", "B06AX04" ], "active_substances": [ "Mitapivat Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1662/006", "product_name": "Pyrukynd 50 mg film-coated tablets", "holder": "Agios Netherlands B.V.", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B06", "B06AX04" ], "active_substances": [ "Mitapivat Sulfate" ], "routes": [ "Oral use" 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"holder": "Novartis Europharm Limited", "authorised_date": "2022-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01", "L01EA06" ], "active_substances": [ "Asciminib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1670/003-004", "product_name": "Scemblix 40 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2022-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA06" ], "active_substances": [ "Asciminib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1670/006-007", "product_name": "Scemblix 100 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA06" ], "active_substances": [ "Asciminib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1671/01", "product_name": "Sunlenca 300 mg film-coated tablets", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2022-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX", "J05AX31" ], "active_substances": [ "Lenacapavir sodium" ], "routes": [ "Oral use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1671/02", "product_name": "Sunlenca 464 mg solution for injection", "holder": "Gilead Sciences Ireland UC", "authorised_date": "2022-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J05AX31" ], "active_substances": [ "Lenacapavir sodium" ], "routes": [ "Oral use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1672/001-002", "product_name": "LIVTENCITY 200 mg film-coated tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX10" ], "active_substances": [ "Maribavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1673/001", "product_name": "Ranivisio 10 mg/ml solution for injection", "holder": "Midas Pharma GmbH", "authorised_date": "2022-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA04" ], "active_substances": [ "Ranibizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1674/001", "product_name": "Vyvgart 20 mg/mL concentrate for solution for infusion", "holder": "Argenx", "authorised_date": "2022-08-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA58" ], "active_substances": [ "Efgartigimod ALFA" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1674/002", "product_name": "Vyvgart 1000 mg solution for injection", "holder": "Argenx", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AA58" ], "active_substances": [ "Efgartigimod ALFA" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1675/001", "product_name": "TECVAYLI 10 mg/mL solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2022-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01FX24" ], "active_substances": [ "Teclistamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1675/002", "product_name": "TECVAYLI 90 mg/mL solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2022-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01FX24" ], "active_substances": [ "Teclistamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1676/001", "product_name": "Thalidomide Lipomed 100 mg coated tablets", "holder": "Lipomed GmbH", "authorised_date": "2022-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "L04AX02" ], "active_substances": [ "Thalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1677/001-002", "product_name": "Tezspire 210 mg solution for injection in pre-filled syringe", "holder": "AstraZeneca AB", "authorised_date": "2022-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "R03DX11" ], "active_substances": [ "Tezepelumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1678/001", "product_name": "Lupkynis 7.9 mg soft capsules", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD03" ], "active_substances": [ "Voclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1679/001", "product_name": "Opdualag 240 mg/80 mg sterile concentrate", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2022-06-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XY", "L01XY03" ], "active_substances": [ "RELATLIMAB", "Nivolumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1680/001-006", "product_name": "Lutetium (177Lu) chloride Billev 51.8 GBq/mL radiopharmaceutical precursor, solution", "holder": "Billev Pharma ApS", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Radiopharmaceutical precursor, solution", "atc_codes": [ "V10X" ], "active_substances": [ "Lutetium (177lu) chloride" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1681/001", "product_name": "Amvuttra 25 mg solution for injection in pre-filled syringe", "holder": "Alnylam Netherlands B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N07XX", "N07XX18" ], "active_substances": [ "Vutrisiran Sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1683/001", "product_name": "Vabysmo 120 mg/mL solution for injection", "holder": "Roche Registration GmbH", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA09" ], "active_substances": [ "Faricimab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1683/002", "product_name": "Vabysmo 120 mg/mL solution for injection in pre-filled syringe", "holder": "Roche Registration GmbH", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA09" ], "active_substances": [ "Faricimab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1684/001", "product_name": "NULIBRY 9.5 mg powder for solution for injection", "holder": "TMC Pharma (EU) Limited", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "A16AX", "A16AX19" ], "active_substances": [ "Fosdenopterin hydrobromide dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/001-003", "product_name": "Mounjaro 2.5 mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/004-006", "product_name": "Mounjaro 5 mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/007-009", "product_name": "Mounjaro 7.5 mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/010-012", "product_name": "Mounjaro 10 mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/013-015", "product_name": "Mounjaro 12.5 mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/016-018", "product_name": "Mounjaro 15 mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2022-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/049-050", "product_name": "Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/051-052", "product_name": "Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/053-054", "product_name": "Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/055-056", "product_name": "Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/057-058", "product_name": "Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1685/059-060", "product_name": "Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BX16" ], "active_substances": [ "Tirzepatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1687/001-002", "product_name": "Enjaymo 50 mg/mL solution for infusion", "holder": "Recordati Rare Diseases", "authorised_date": "2022-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "L04", "L04AA55" ], "active_substances": [ "Sutimlimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1688/001", "product_name": "Spevigo 450 mg concentrate for solution for infusion", "holder": "LEO Pharma A/S", "authorised_date": "2022-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC", "L04AC22" ], "active_substances": [ "Spesolimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1688/002", "product_name": "Spevigo 150 mg solution for injection in pre-filled syringe", "holder": "LEO Pharma A/S", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC22" ], "active_substances": [ "Spesolimab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1688/003", "product_name": "Spevigo 300 mg solution for injection in pre-filled syringe", "holder": "LEO Pharma A/S", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion in pre-filled syringe", "atc_codes": [ "L04AC22" ], "active_substances": [ "Spesolimab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1689/001-003", "product_name": "Beyfortus 50 mg solution for injection in pre-filled syringe", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2022-10-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J06B", "J06BD08" ], "active_substances": [ "Nirsevimab" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1689/004-006", "product_name": "Beyfortus 100 mg solution for injection in pre-filled syringe", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2022-10-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in 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"EU/1/22/1691/002", "product_name": "Ximluci 10 mg/mL solution for injection", "holder": "Stada Arzneimittel AG", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA04" ], "active_substances": [ "Ranibizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1692/001", "product_name": "Locametz 25 micrograms kit for radiopharmaceutical preparation", "holder": "Novartis Europharm Limited", "authorised_date": "2022-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09I", "V09IX14" ], "active_substances": [ "Gozetotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1693/001-004", "product_name": "Teriflunomide Accord 14 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA31" ], "active_substances": [ "Teriflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1693/005-012", "product_name": "Teriflunomide Accord 7 mg film-coated tablets", 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], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1695/001", "product_name": "Zynlonta 10 mg powder for concentrate for solution for infusion", "holder": "Swedish Orphan Biovitrum AB", "authorised_date": "2022-12-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX22", "L01XC" ], "active_substances": [ "Loncastuximab Tesirine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1696/001", "product_name": "Sorafenib Accord 200 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2022-11-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01", "L01EX02" ], "active_substances": [ "Sorafenib Tosilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1697/001-002", "product_name": "Teriparatide SUN 20 micrograms/80 microliters solution for injection in pre-filled pen", "holder": "Sun Phamaceutical Industries Europe B.V.", "authorised_date": "2022-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J07BX04" ], "active_substances": [ "Dengue virus serotype 1# (live, attenuated)", "Dengue virus, serotype 2, live, attenuated", "Dengue virus serotype 3# (live, attenuated)", "Dengue virus serotype 4# (live, attenuated)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1699/001", "product_name": "Qdenga powder and solvent for solution for injection", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2022-12-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J07B", "J07BX04" ], "active_substances": [ 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"Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1699/003", "product_name": "Qdenga powder and solvent for solution for injection", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2022-12-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J07B", "J07BX04" ], "active_substances": [ "Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated", "Dengue virus, serotype 2, live, attenuated", "Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated", "Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, 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"Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1704/006", "product_name": "Livmarli 30 mg tablets", "holder": "Mirum Pharmaceuticals International B.V.", "authorised_date": "2026-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A05AX04" ], "active_substances": [ "Maralixibat Chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1705/001", "product_name": "Pemetrexed Baxter 100 mg powder for concentrate for solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2022-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for 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(Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1706/001", "product_name": "Eladynos 80 micrograms/dose solution for injection in pre-filled pen", "holder": "Theramex Ireland Limited", "authorised_date": "2022-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H05AA", "H05AA04" ], "active_substances": [ "Abaloparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1707/001-007", "product_name": "Pirfenidone Viatris 267 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2023-01-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated 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"Pirfenidone Viatris 801 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2023-01-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1708/001", "product_name": "Sugammadex – Amomed®", "holder": "Aop Orphan Pharmaceuticals GmbH", "authorised_date": "2023-01-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1709/001-004", "product_name": "BIMERVAX emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted)", "holder": "Hipra Human Health S.L.", "authorised_date": "2023-03-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Emulsion for injection", "atc_codes": [ "J07BN01" ], "active_substances": [ "SARS-CoV-2 virus, variants B.1.351-B.1.1.7, spike protein, receptor binding domain fusion heterodimer" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1709/005-007", "product_name": "BIMERVAX XBB.1.16. COVID-19 Vaccine (recombinant, adjuvanted)", "holder": "Hipra Human Health S.L.", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Emulsion for injection", "atc_codes": [ "J07BN04" ], "active_substances": [ "SARS-CoV-2, variant XBB.1.16, spike protein, receptor binding domain fusion homodimer" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1710/001-002", "product_name": "Kauliv 20 micrograms/80 microliters solution for injection", "holder": "Strides Pharma (Cyprus) Limited", "authorised_date": "2023-01-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1713/001-002", "product_name": "IMJUDO 20 mg/ml concentrate for solution for infusion", "holder": "AstraZeneca AB", "authorised_date": "2023-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FX20", "L01XC" ], "active_substances": [ "Tremelimumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1714/001-003", "product_name": "Pombiliti 105 mg powder for concentrate for solution for infusion", "holder": "Amicus Therapeutics Europe Limited", "authorised_date": "2023-03-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "A16AB", "A16AB23" ], "active_substances": [ "Cipaglucosidase alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/22/1715/001", "product_name": "Hemgenix 1 x 10^13 genome copies/mL concentrate for solution for infusion", "holder": "CSL Behring GmbH", "authorised_date": "2023-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B02BD" ], "active_substances": [ "Etranacogene dezaparvovec" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1716/001-002/009", "product_name": "Camzyos 2.5 mg Capsule hard", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2023-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C01EB", "C01EB24" ], "active_substances": [ "Mavacamten" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1716/003-004/010", "product_name": "Camzyos 5 mg Capsule hard", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2023-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C01EB", "C01EB24" ], "active_substances": [ "Mavacamten" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1716/005-006/011", "product_name": "Camzyos 10 mg Capsule hard", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2023-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C01EB", "C01EB24" ], "active_substances": [ "Mavacamten" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1716/007-008/012", "product_name": "Camzyos 15 mg Capsule hard", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2023-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C01EB", "C01EB24" ], "active_substances": [ "Mavacamten" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1717/001-003", "product_name": "Aqumeldi 0.25 mg Orodispersible tablet", "holder": "Proveca Pharma Limited", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1717/004-006", "product_name": "Aqumeldi 1 mg orodispersible tablets", "holder": "Proveca Pharma Limited", "authorised_date": "2025-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1718/001-008", "product_name": "SOTYKTU 6 mg Film-coated tablet", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2023-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA56" ], "active_substances": [ "Deucravacitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1719/001-004", "product_name": "Tolvaptan Accord 7.5 mg Tablet", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2023-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03XA01" ], "active_substances": [ "Tolvaptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1720/001-003", "product_name": "Sitagliptin/Metformin hydrochloride SUN 50 mg/850 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Fumarate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1720/004-006", "product_name": "Sitagliptin/Metformin hydrochloride SUN 50 mg/1000 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Fumarate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1721/001-012", "product_name": "Dapagliflozin Viatris 5 mg Film-coated tablet", "holder": "Viatris Limited", "authorised_date": "2023-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1721/013-024", "product_name": "Dapagliflozin Viatris 10 mg Film-coated tablet", "holder": "Viatris Limited", "authorised_date": "2023-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1722/001", "product_name": "Akeega 50 mg/500 mg Film-coated tablet", "holder": "Janssen-Cilag International NV", "authorised_date": "2023-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XK52" ], "active_substances": [ "Niraparib Tosilate Monohydrate", "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1722/002", "product_name": "Akeega 100mg/500 mg Film-coated tablet", "holder": "Janssen-Cilag International NV", "authorised_date": "2023-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XK52" ], "active_substances": [ "Niraparib Tosilate Monohydrate", "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1723/001", "product_name": "HYFTOR 2 mg/g Gel", "holder": "Plusultra Pharma GmbH", "authorised_date": "2023-05-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "L04AA10" ], "active_substances": [ "Sirolimus" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1724/001-003", "product_name": "Elfabrio 2 mg/ml Concentrate for solution for infusion", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2023-05-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "A16AB", "A16AB20" ], "active_substances": [ "Pegunigalsidase Alfa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1725/001-002", "product_name": "VAFSEO 150 mg Film-coated tablet", "holder": "Medice Arzneimittel Putter GmbH & Co. K.G", "authorised_date": "2023-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA08" ], "active_substances": [ "Vadadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1725/003-004", "product_name": "VAFSEO 300 mg Film-coated tablet", "holder": "Medice Arzneimittel Putter GmbH & Co. K.G", "authorised_date": "2023-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA08" ], "active_substances": [ "Vadadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1725/005-006", "product_name": "VAFSEO 450 mg Film-coated tablet", "holder": "Medice Arzneimittel Putter GmbH & Co. K.G", "authorised_date": "2023-04-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B03XA", "B03XA08" ], "active_substances": [ "Vadadustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1726/001", "product_name": "Opzelura 15 mg/g Cream", "holder": "Incyte Biosciences Distribution B.V.", "authorised_date": "2023-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D11AH", "D11AH09" ], "active_substances": [ "Ruxolitinib" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1727/001", "product_name": "BEKEMV 300 mg Concentrate for solution for infusion", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2023-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AJ01" ], "active_substances": [ "Eculizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1728/001", "product_name": "Tibsovo 250 mg Film-coated tablet", "holder": "Les Laboratoires Servier", "authorised_date": "2023-05-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XM02" ], "active_substances": [ "Ivosidenib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1730/001", "product_name": "Briumvi 150 mg Concentrate for solution for infusion", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2023-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04", "L04AG14" ], "active_substances": [ "Ublituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1731/001", "product_name": "Qaialdo 10 mg/ml oral suspension", "holder": "Lipomed GmbH", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1732/001", "product_name": "Lacosamide Adroiq 10 mg/ml solution for infusion", "holder": "Extrovis EU Kft.", "authorised_date": "2023-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1733/001-002", "product_name": "Sugammadex Adroiq 100 mg/mL solution for injection", "holder": "Extrovis EU Kft.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1734/001", "product_name": "Pedmarqsi 80 mg/mL solution for infusion", "holder": "Norgine B.V.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "V03AB06" ], "active_substances": [ "Sodium thiosulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1735/001", "product_name": "Epysqli 300 mg concentrate for solution for infusion", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA25" ], "active_substances": [ "Eculizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1736/001", "product_name": "Omvoh 300 mg concentrate for solution for infusion", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC24" ], "active_substances": [ "MIRIKIZUMAB" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1736/002-003", "product_name": "Omvoh 100 mg solution for injection in pre-filled syringe", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC24" ], "active_substances": [ "MIRIKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1736/004-006", "product_name": "Omvoh 100mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC24" ], "active_substances": [ "MIRIKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1736/007-008", "product_name": "Omvoh 100mg +200mg solution for injection in pre-filled syringe", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC24" ], "active_substances": [ "MIRIKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1736/009-010", "product_name": "Omvoh 100mg + 200mg solution for injection in pre-filled pen", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC24" ], "active_substances": [ "MIRIKIZUMAB" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1737/001-002", "product_name": "Opfolda 65 mg hard capsules", "holder": "Amicus Therapeutics Europe Limited", "authorised_date": "2023-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX06" ], "active_substances": [ "Miglustat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1738/001-003", "product_name": "Jaypirca 50 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2023-10-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EL05" ], "active_substances": [ "Pirtobrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1738/004-009", "product_name": "Jaypirca 100 mg film-coated tablets", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2023-10-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EL05" ], "active_substances": [ "Pirtobrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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adjuvanted)", "holder": "GlaxoSmithKline Biologicals", "authorised_date": "2023-06-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and suspension for suspension for injection", "atc_codes": [ "J07BX05" ], "active_substances": [ "Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1741/001-003", "product_name": "Lytgobi 4 mg film-coated tablet", "holder": "Taiho Pharma Netherlands B.V.", "authorised_date": "2023-07-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE51" ], "active_substances": [ "Futibatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1742/001", "product_name": "Columvi 2.5 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01", "L01FX28" ], "active_substances": [ "Glofitamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1742/002", "product_name": "Columvi 10 mg concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01", "L01FX28" ], "active_substances": [ "Glofitamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1743/001-002", "product_name": "ZTALMY 50 mg/mL oral suspension", "holder": "Marinus Pharmaceuticals Emerald Limited", "authorised_date": "2023-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AX", "N03AX27" ], "active_substances": [ "Ganaxolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1744/001-002", "product_name": "KRAZATI 200 mg film-coated tablets", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX77" ], "active_substances": [ "Adagrasib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1745/001", "product_name": "Tyruko 300 mg concentrate for solution for infusion", "holder": "Polpharma Biologics S.A.", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA23" ], "active_substances": [ "Natalizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1746/001", "product_name": "Pylclari 1000 MBq/mL solution for injection", "holder": "Curium Pet France", "authorised_date": "2023-07-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09IX", "V09IX16" ], "active_substances": [ "2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1747/001", "product_name": "Enrylaze 10 mg/0.5 mL solution for injection/infusion.", "holder": "Jazz Pharmaceuticals Ireland Limited", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01XX02" ], "active_substances": [ "Crisantaspase" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1748/001", "product_name": "TALVEY 2 mg/mL solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2023-08-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01", "L01FX29" ], "active_substances": [ "Talquetamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1748/002", "product_name": "TALVEY 40 mg/mL solution for injection", "holder": "Janssen-Cilag International NV", "authorised_date": "2023-08-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01", "L01FX29" ], "active_substances": [ "Talquetamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1750/001-002", "product_name": "AQUIPTA 10 mg tablets", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2023-08-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02C", "N02CD07" ], "active_substances": [ "Atogepant monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1750/003-004", "product_name": "AQUIPTA 60 mg tablets", "holder": "AbbVie Deutschland GmbH & Co. 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"supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1752/001-006", "product_name": "Abrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent, recombinant)", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2023-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J07BX05" ], "active_substances": [ "Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A", "Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1752/007-009", "product_name": "Abrysvo powder and solvent for solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2023-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J07BX05" ], "active_substances": [ "Respiratory syncytial virus, subgroup A, stabilized prefusion F protein 847A", "Respiratory syncytial virus, subgroup B, stabilized prefusion F protein 847B" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1753/001-002", "product_name": "Degarelix Accord 80 mg powder and solvent for solution for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2023-09-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02BX02" ], "active_substances": [ "Degarelix Acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1753/003", "product_name": "Degarelix Accord 120 mg powder and solvent for solution for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2023-09-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02BX02" ], "active_substances": [ "Degarelix Acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1754/001-006", "product_name": "Tyenne 20 mg/mL concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1754/007-009", "product_name": "Tyenne 162 mg solution for injection in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1754/010-012", "product_name": "Tyenne 162 mg solution for injection in pre-filled pen", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1755/001-003", "product_name": "Litfulo 50 mg hard capsules", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AF08" ], "active_substances": [ "Ritlecitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1756/001", "product_name": "Inaqovi 35 mg/100 mg film-coated tablets", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01BC58" ], "active_substances": [ "Decitabine", "Cedazuridine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1757/001", "product_name": "ORSERDU 86 mg film-coated tablets", "holder": "Stemline Therapeutics B.V.", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BA04" ], "active_substances": [ "Elacestrant Dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1757/002", "product_name": "ORSERDU 345 mg film-coated tablets", "holder": "Stemline Therapeutics B.V.", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BA", "L02BA04" ], "active_substances": [ "Elacestrant Dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1758/001-002", "product_name": "Tevimbra 100 mg concentrate for solution for infusion", "holder": "BeiGene Ireland Limited", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01", "L01FF09" ], "active_substances": [ "Tislelizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1759/001", "product_name": "Tepkinly 4 mg/0.8 ml solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for injection", "atc_codes": [ "L01FX18" ], "active_substances": [ "Epcoritamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1759/002", "product_name": "Tepkinly 48 mg solution for injection", "holder": "AbbVie Deutschland GmbH & Co. KG", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01FX18" ], "active_substances": [ "Epcoritamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1760/001", "product_name": "Apretude 600 mg prolonged-release suspension for injection", "holder": "ViiV Healthcare BV", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AJ04" ], "active_substances": [ "Cabotegravir Sodium", "cabotegravir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1761/001-002", "product_name": "Zoonotic Influenza Vaccine Seqirus suspension for injection in pre-filled syringe", "holder": "Seqirus S.r.l.", "authorised_date": "2023-10-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07BB02" ], "active_substances": [ "A/TURKEY/TURKEY/1/05 (H5N1)-LIKE STRAIN (NIBRG-23)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1762/001", "product_name": "Herwenda 150 mg powder for concentrate for solution for infusion", "holder": "Sandoz GmbH", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1763/001-004", "product_name": "Catiolanze 50 micrograms/mL eye drops, emulsion", "holder": "Santen OY", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, emulsion in single-dose container", "atc_codes": [ "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1764/001-002", "product_name": "Zilbrysq 16.6 mg solution for injection in pre-filled syringe", "holder": "UCB Pharma S.A.", "authorised_date": "2023-12-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AJ06" ], "active_substances": [ "Zilucoplan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1764/003-004", "product_name": "Zilbrysq 23 mg solution for injection in pre-filled syringe", "holder": "UCB Pharma S.A.", "authorised_date": "2023-12-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AJ06" ], "active_substances": [ "Zilucoplan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1764/005-006", "product_name": "Zilbrysq 32.4 mg solution for injection in pre-filled syringe", "holder": "UCB Pharma S.A.", "authorised_date": "2023-12-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AJ06" ], "active_substances": [ "Zilucoplan" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1765/001-006", "product_name": "Ebglyss 250 mg solution for injection in pre-filled syringe", "holder": "Almirall, S.A.", "authorised_date": "2023-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "D11AH10" ], "active_substances": [ "Lebrikizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1765/007-012", "product_name": "Ebglyss 250 mg solution for injection in pre-filled pen", "holder": "Almirall, S.A.", "authorised_date": "2023-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "D11AH10" ], "active_substances": [ "Lebrikizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1766/001", "product_name": "Yorvipath 168 micrograms/0.56 mL solution for injection in pre-filled pen", "holder": "Ascendis Pharma Bone Diseases A/S", "authorised_date": "2023-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA05" ], "active_substances": [ "Palopegteriparatide", "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1766/002", "product_name": "Yorvipath 294 micrograms/0.98 mL solution for injection in pre-filled pen", "holder": "Ascendis Pharma Bone Diseases A/S", "authorised_date": "2023-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA05" ], "active_substances": [ "Palopegteriparatide", "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1766/003", "product_name": "Yorvipath 420 micrograms/1.4 mL solution for injection in pre-filled pen", "holder": "Ascendis Pharma Bone Diseases A/S", "authorised_date": "2023-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA05" ], "active_substances": [ "Palopegteriparatide", "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1767/001-002", "product_name": "Finlee 10 mg dispersible tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2023-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "L01EC02" ], "active_substances": [ "Dabrafenib Mesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1768/001-002", "product_name": "VANFLYTA 17.7 mg film-coated tablets", "holder": "Daiichi Sankyo Europe GmbH", "authorised_date": "2023-11-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX11" ], "active_substances": [ "QUIZARTINIB DIHYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1768/003-005", "product_name": "VANFLYTA 26.5 mg film-coated tablets", "holder": "Daiichi Sankyo Europe GmbH", "authorised_date": "2023-11-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX11" ], "active_substances": [ "QUIZARTINIB DIHYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1769/001-006", "product_name": "Dabigatran etexilate Teva 75 mg hard capsules", "holder": "TEVA GmbH", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1769/007-015", "product_name": "Dabigatran etexilate Teva 110 mg hard capsules", "holder": "TEVA GmbH", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1769/016-023", "product_name": "Dabigatran etexilate Teva 150 mg hard capsules", "holder": "TEVA GmbH", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1770/001-002", "product_name": "ELREXFIO 40 mg/mL solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2023-12-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01" ], "active_substances": [ "Elranatamab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1771/001-003", "product_name": "Veoza 45 mg film-coated tablets", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2023-12-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G02CX06" ], "active_substances": [ "Fezolinetant" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1772/001-010", "product_name": "Elucirem 0.5mmol/mL solution for injection", "holder": "Guerbet", "authorised_date": "2023-12-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA12" ], "active_substances": [ "Gadopiclenol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1773/001-010", "product_name": "Vueway 0.5 mmol/mL solution for injection", "holder": "Bracco Imaging spa", "authorised_date": "2023-12-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA12" ], "active_substances": [ "Gadopiclenol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1774/001-002", "product_name": "Loargys 5 mg/ml solution for injection/infusion", "holder": "Immedica Pharma AB", "authorised_date": "2023-12-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "A16AB24" ], "active_substances": [ "Pegzilarginase" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1775/001", "product_name": "REZZAYO 200 mg powder for concentrate for solution for infusion", "holder": "Mundipharma GmbH", "authorised_date": "2023-12-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX08" ], "active_substances": [ "Rezafungin acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1776/001", "product_name": "AGAMREE 40 mg/ml oral suspension", "holder": "Santhera Pharmaceuticals (Deutschland) GmbH", "authorised_date": "2023-12-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "H02AB18" ], "active_substances": [ "Vamorolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1777/001", "product_name": "Azacitidine Kabi 25 mg/mL powder for suspension for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1778/001", "product_name": "Naveruclif 5 mg/ml powder for dispersion for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for dispersion for infusion", "atc_codes": [ "L01CD01" ], "active_substances": [ "Paclitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1779/001-002", "product_name": "Rimmyrah", "holder": "Qilu Pharma Spain S.L.", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA04" ], "active_substances": [ "Ranibizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1780/001", "product_name": "Rystiggo 140 mg/ml solution for injection", "holder": "UCB Pharma S.A.", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AG16" ], "active_substances": [ "Rozanolixizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1781/001", "product_name": "Spexotras 0.05 mg/ml powder for oral solution", "holder": "Novartis Europharm Limited", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "L01EE01" ], "active_substances": [ "Trametinib dimethyl sulfoxide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1782/001", "product_name": "Omjjara 100 mg film-coated tablets", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2024-01-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EJ04" ], "active_substances": [ "Momelotinib Dihydrochloride Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1782/002", "product_name": "Omjjara 150 mg film-coated tablets", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2024-01-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EJ04" ], "active_substances": [ "Momelotinib Dihydrochloride Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1782/003", "product_name": "Omjjara 200 mg film-coated tablets", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2024-01-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EJ04" ], "active_substances": [ "Momelotinib Dihydrochloride Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1783/001", "product_name": "Qalsody 100 mg solution for injection", "holder": "Biogen Netherlands B.V.", "authorised_date": "2024-05-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N07XX22" ], "active_substances": [ "Tofersen" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1784/001", "product_name": "Uzpruvo 45 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1784/004", "product_name": "Uzpruvo 90 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1784/005", "product_name": "Uzpruvo 130 mg concentrate for solution for infusion", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1785/001-004", "product_name": "Pomalidomide Viatris 1 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2024-02-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1785/005-008", "product_name": "Pomalidomide Viatris 2 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2024-02-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1785/009-012", "product_name": "Pomalidomide Viatris 3 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2024-02-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1785/013-016", "product_name": "Pomalidomide Viatris 4 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2024-02-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1786/001-002", "product_name": "Skyclarys 50 mg hard capsules", "holder": "Biogen Netherlands B.V.", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N07XX25" ], "active_substances": [ "Omaveloxolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09XX01" ], "active_substances": [ "Sparsentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1788/002-003", "product_name": "Filspari 400 mg film-coated tablets", "holder": "Vifor France", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09XX01" ], "active_substances": [ "Sparsentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1789/001", "product_name": "Mevlyq 0.44 mg/mL solution for injection", "holder": "Yes Pharmaceutical Development Services GmbH", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX41" ], "active_substances": [ "Eribulin mesylate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/23/1790/001-003", "product_name": "Velsipity 2 mg film-coated tablets", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2024-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AE05" ], "active_substances": [ "Etrasimod 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"Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1793/001", "product_name": "Ryzneuta 20 mg solution for injection", "holder": "Fisiopharma SrL", "authorised_date": "2024-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA18" ], "active_substances": [ "Efbemalenograstim alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1794/001", "product_name": "EXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion", "holder": "Advanz Pharma Limited", "authorised_date": "2024-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for 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"Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1795/002", "product_name": "Niapelf 50 mg prolonged-release suspension for injection", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2024-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1795/003", "product_name": "Niapelf 75 mg prolonged-release suspension for injection", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2024-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1795/004", "product_name": "Niapelf 100 mg prolonged-release suspension for injection", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2024-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1796/001", "product_name": "Apremilast Accord 10 mg film-coated tablets Apremilast Accord 20 mg film-coated tablets Apremilast Accord 30 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1796/002-004", "product_name": "Apremilast Accord 30 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1796/005", "product_name": "Apremilast Accord 10 mg film-coated tablets Apremilast Accord 20 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1796/006-007", "product_name": "Apremilast Accord 20 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1798/001", "product_name": "Lytenava 25 mg/mL solution for injection", "holder": "Outlook Therapeutics NL B.V.", "authorised_date": "2024-05-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA08" ], "active_substances": [ "Bevacizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1799/001", "product_name": "Tauvid 800 MBq/mL solution for injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2024-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AX07" ], "active_substances": [ "Flortaucipir (18F)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1800/001", "product_name": "Zynyz 500 mg concentrate for solution for infusion", "holder": "Incyte Biosciences Distribution B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FF10" ], "active_substances": [ "Retifanlimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1801/001", "product_name": "Pyzchiva 45 mg solution for injection in pre-filled 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[ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1802/001-003", "product_name": "FABHALTA 200 mg hard capsules", "holder": "Novartis Europharm Limited", "authorised_date": "2024-05-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AJ08" ], "active_substances": [ "Iptacopan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1803/001-006", "product_name": "Nintedanib Accord 100 mg soft capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-19", "product_type": "HM", 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"DOPAMINE HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1805/001-002", "product_name": "Agilus 120 mg powder for solution for injection", "holder": "Norgine B.V.", "authorised_date": "2024-05-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03CA01" ], "active_substances": [ "Dantrolene Sodium, Hemiheptahydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1806/001", "product_name": "Celldemic 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"Seqirus Netherlands B.V.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1808/001", "product_name": "Emblaveo 1.5 g/0.5 g powder for concentrate for solution for infusion", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01DF51" ], "active_substances": [ "Avibactam sodium", "Aztreonam beta form" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1809/001-003", "product_name": "Buprenorphine Neuraxpharm", "holder": "Laboratorios Lesvi, S.L.", "authorised_date": "2024-12-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual film", "atc_codes": [ "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1809/004-006", "product_name": "Buprenorphine Neuraxpharm", "holder": "Laboratorios Lesvi, S.L.", "authorised_date": "2024-12-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual film", "atc_codes": [ "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1809/007-009", "product_name": "Buprenorphine Neuraxpharm", "holder": "Laboratorios Lesvi, S.L.", "authorised_date": "2024-12-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual film", "atc_codes": [ "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1809/010-012", "product_name": "Buprenorphine Neuraxpharm", "holder": "Laboratorios Lesvi, S.L.", "authorised_date": "2024-12-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Sublingual film", "atc_codes": [ "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1810/001-003", "product_name": "Dimethyl fumarate Neuraxpharm 120 mg gastro-resistant hard capsules", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1810/004-008", "product_name": "Dimethyl fumarate Neuraxpharm 240 mg gastro-resistant hard capsules", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1811/001-002", "product_name": "Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1811/003-006", "product_name": "Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1812/001", "product_name": "Wyost 120 mg solution for injection", "holder": "Sandoz GmbH", "authorised_date": "2024-05-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1813/001", "product_name": "Jubbonti 60 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1814/001-004", "product_name": "Dimethyl fumarate Mylan 120 mg gastro-resistant hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1814/005-010", "product_name": "Dimethyl fumarate Mylan 240 mg gastro-resistant hard capsules", "holder": "Mylan Pharmaceuticals Limited", "authorised_date": "2024-04-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1815/001-014", "product_name": "Awiqli 700 units/mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2024-05-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE07" ], "active_substances": [ "Insulin icodec" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1816/001-002", "product_name": "Fluenz nasal spray suspension Influenza vaccine (live, nasal)", "holder": "AstraZeneca AB", "authorised_date": "2024-06-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "J07BB03" ], "active_substances": [ "REASSORTANT 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"routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1817/002-004", "product_name": "Omlyclo 150 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2024-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "R03DX05" ], "active_substances": [ "Omalizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1817/014-017", "product_name": "Omlyclo 300 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "R03DX05" ], "active_substances": [ "Omalizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 13(4) of Directive No 2001/82/EC)" }, { "licence_number": "EU/1/24/1817/018-021", "product_name": "Omlyclo 300 mg solution for injection in pre-filled pen", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-11-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "R03DX05" ], "active_substances": [ "Omalizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 13(4) of Directive No 2001/82/EC)" }, { "licence_number": "EU/1/24/1818/001-002", "product_name": "JERAYGO 12.5 mg film-coated tablets", "holder": "Idorsia Pharmaceuticals Deutschland GmbH", "authorised_date": "2024-06-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KN01" ], "active_substances": [ "Aprocitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1818/003-004", "product_name": "JERAYGO 25 mg 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"Film-coated tablet", "atc_codes": [ "L01EX27" ], "active_substances": [ "Capivasertib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1822/001-006", "product_name": "Obgemsa 75 mg film-coated tablets", "holder": "Pierre Fabre Medicament", "authorised_date": "2024-06-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD15" ], "active_substances": [ "Vibegron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1823/001", "product_name": "WEZENLA 45 mg Solution for injection", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2024-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1823/002", "product_name": "WEZENLA 45 mg Solution for injection pre-filled syringe", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2024-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1823/003", "product_name": "WEZENLA 90 mg Solution for injection pre-filled syringe", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2024-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1823/004", "product_name": "WEZENLA 130 mg Concentrate for solution for infusion", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2024-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1824/001", "product_name": "ALTUVOCT 250 IU Powder and solvent for solution for injection", "holder": "Swedish Orphan Biovitrum AB(publ)", "authorised_date": "2024-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ 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"HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection in pre-filled syringe", "atc_codes": [ "C02KX06" ], "active_substances": [ "Sotatercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1851/001-002", "product_name": "Anzupgo 20 mg/g cream", "holder": "LEO Pharma A/S", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D11AH11" ], "active_substances": [ "Delgocitinib" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 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], "active_substances": [ "Toripalimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1854/001", "product_name": "KAYFANDA 200 microgram hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1854/002", "product_name": "KAYFANDA 400 microgram hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1854/003", "product_name": "KAYFANDA 600 microgram hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1854/004", "product_name": "KAYFANDA 1200 microgram hard capsules", "holder": "Ipsen Pharma", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX05" ], "active_substances": [ "Odevixibat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1855/001", "product_name": "Iqirvo 80 mg film-coated tablets", "holder": "Ipsen Pharma", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AX06" ], "active_substances": [ "Elafibranor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1856/001-002", "product_name": "Vyloy 100 mg powder for concentrate for solution for infusion.", "holder": "Astellas Pharma Europe B.V.", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX31" ], "active_substances": [ "Zolbetuximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1857/001", "product_name": "Vevizye 1 mg/mL eye drops, solution", "holder": "Laboratoires Thea", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01XA18" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1859/001", "product_name": "Yuvanci 10 mg/20 mg film-coated tablets", "holder": "Janssen Pharmaceutica NV", "authorised_date": "2024-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX54" ], "active_substances": [ "Macitentan", "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1859/002", "product_name": "Yuvanci 10 mg/40 mg film-coated tablets", "holder": "Janssen Pharmaceutica NV", "authorised_date": "2024-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX54" ], "active_substances": [ "Macitentan", "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1860/001", "product_name": "Epruvy 10 mg/ml solution for injection (previously Ranibizumab Midas)", "holder": "Midas Pharma GmbH", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01LA04" ], "active_substances": [ "Ranibizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1861/001-002", "product_name": "Ituxredi 100 mg concentrate for solution for infusion", "holder": "Reddy Holding GmbH", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FA01" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1861/003-004", "product_name": "Ituxredi 500 mg concentrate for solution for infusion", "holder": "Reddy Holding GmbH", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FA01" ], "active_substances": [ "Rituximab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1862/001", "product_name": "Fymskina 45 mg Solution for injection", "holder": "Formycon AG", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1862/002", "product_name": "Fymskina 90 mg Solution for injection", "holder": "Formycon AG", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1862/003", "product_name": "Fymskina 130 mg Concentrate for solution for infusion", "holder": "Formycon AG", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1863/001", "product_name": "Otulfi 45 mg Solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1863/002", "product_name": "Otulfi 90 mg Solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1863/003", "product_name": "Otulfi 130 mg Concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1863/005", "product_name": "Otulfi 45 mg Solution for injection pre-filled pen", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled 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"EU/1/24/1864/001", "product_name": "Tuznue 150 mg Powder for concentrate for solution for infusion", "holder": "Prestige Biopharma Belgium", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1864/002", "product_name": "Tuznue 420 mg Powder for concentrate for solution for infusion", "holder": "Prestige Biopharma Belgium", "authorised_date": "2024-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1865/001-002", "product_name": "Opuviz 40 mg/mL solution for injection in a vial", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2024-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1866/001", "product_name": "ELAHERE 5 mg/mL concentrate for solution for infusion", "holder": "Immunogen Biopharma (Ireland) Limited", "authorised_date": "2024-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01FX26" ], "active_substances": [ "Mirvetuximab soravtansine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1867/001", "product_name": "Afqlir", "holder": "Sandoz GmbH", "authorised_date": "2024-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1867/002", "product_name": "Afqlir", "holder": "Sandoz GmbH", "authorised_date": "2024-11-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1868/001-012", "product_name": "Pomalidomide Teva 1 mg Capsule, hard", "holder": "TEVA GmbH", "authorised_date": "2024-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1868/013-024", "product_name": "Pomalidomide Teva 2 mg Capsule, hard", "holder": "TEVA GmbH", "authorised_date": "2024-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1868/025-036", "product_name": "Pomalidomide Teva 3 mg Capsule, hard", "holder": "TEVA GmbH", "authorised_date": "2024-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1868/037-048", "product_name": "Pomalidomide Teva 4 mg Capsule, hard", "holder": "TEVA GmbH", "authorised_date": "2024-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1869/001-004", "product_name": "Eltrombopag Viatris 12.5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1869/005-008", "product_name": "Eltrombopag Viatris 25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1869/009-012", "product_name": "Eltrombopag Viatris 50 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1869/013-016", "product_name": "Eltrombopag Viatris 75 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1870/001", "product_name": "HETRONIFLY 10 mg/ml concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-02-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [], "active_substances": [ "Serplulimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1872/001", "product_name": "Imuldosa 45 mg Solution for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1872/002", "product_name": "Imuldosa 90 mg Solution for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1872/003", "product_name": "Imuldosa 130 mg Concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2024-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1873/001", "product_name": "Kostaive powder for dispersion for injection. COVID-19 sa-mRNA Vaccine", "holder": "Arcturus Therapeutics Europe B.V.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for dispersion for injection", "atc_codes": [ "J07BN01", "J07BX" ], "active_substances": [ "Zapomeran" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1874/001", "product_name": "Hympavzi 150 mg solution for injection in pre-filled syringe", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2024-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B02BX11" ], "active_substances": [ "Marstacimab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1874/002-003", "product_name": "Hympavzi 150 mg solution for injection in pre-filled pen", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2024-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B02BX11" ], "active_substances": [ "Marstacimab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1875/001", "product_name": "Wainzua 45 mg solution for injection in pre-filled pen", "holder": "AstraZeneca AB", "authorised_date": "2025-03-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "N07XX21" ], "active_substances": [ "Eplontersen sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1878/001-004", "product_name": "Fluad suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, adjuvanted)", "holder": "Seqirus Netherlands B.V.", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "A/(H1N1)-LIKE VIRUS ANTIGEN", "A/(H3N2)-LIKE VIRUS ANTIGEN", "B (Victoria lineage)-like virus antigen" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1879/001-004", "product_name": "Flucelvax suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)", "holder": "Seqirus Netherlands B.V.", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "A/(H1N1)-LIKE VIRUS ANTIGEN", "A/(H3N2)-LIKE VIRUS ANTIGEN", "B (Victoria lineage)-like virus antigen" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1881/001-002", "product_name": "Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B02BX10" ], "active_substances": [ "Concizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1881/003-004", "product_name": "Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B02BX10" ], "active_substances": [ "Concizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1881/005-006", "product_name": "Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B02BX10" ], "active_substances": [ "Concizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1881/007", "product_name": "Alhemo 300 mg/3 mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B02BX10" ], "active_substances": [ "Concizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1882/001-002", "product_name": "SIILTIBCY (0.5 microgram + 0.5 microgram)/mL solution for injection", "holder": "Vakzine Projekt Management GmbH", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V04CF" ], "active_substances": [ "rdESAT-6", "rCFP-10" ], "routes": [ "Intradermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1883/001-002", "product_name": "AUGTYRO 40 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX28" ], "active_substances": [ "Repotrectinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1883/003-004", "product_name": "AUGTYRO 160 mg hard capsules", "holder": "Bristol-Myers Squibb Pharma EEIG", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX28" ], "active_substances": [ "Repotrectinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1884/001", "product_name": "Gohibic 200 mg Concentrate for solution for infusion", "holder": "InflaRx GmbH", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AJ10" ], "active_substances": [ "Vilobelimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1885/001-002", "product_name": "ANDEMBRY 200 mg solution for injection in pre-filled syringe", "holder": "CSL Behring GmbH", "authorised_date": "2025-02-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B06AC07" ], "active_substances": [ "Garadacimab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1885/003-004", "product_name": "ANDEMBRY 200 mg solution for injection in pre-filled pen", "holder": "CSL Behring GmbH", "authorised_date": "2025-02-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B06AC07" ], "active_substances": [ "Garadacimab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1886/001-003", "product_name": "Lazcluze 80 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2025-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EB09" ], "active_substances": [ "Lazertinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1886/004-006", "product_name": "Lazcluze 240 mg film-coated tablets", "holder": "Janssen-Cilag International NV", "authorised_date": "2025-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EB09" ], "active_substances": [ "Lazertinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1887/001", "product_name": "Baiama 40 mg/mL solution for injection in a vial", "holder": "Formycon AG", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1888/001", "product_name": "Ahzantive 40 mg/ml Solution for injection", "holder": "Formycon AG", "authorised_date": "2025-01-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1889/001-002", "product_name": "Xbryk 120 mg solution for injection", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1890/001", "product_name": "Obodence 60 mg solution for injection in pre-filled syringe", "holder": "Samsung Bioepis NL B.V.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1891/001-002", "product_name": "LEQEMBI 100 mg/mL concentrate for solution for infusion", "holder": "Eisai GmbH", "authorised_date": "2025-04-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N06DX04" ], "active_substances": [ "Lecanemab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1892/001", "product_name": "Yesintek 45 mg Solution for injection Subcutaneous use", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1892/002", "product_name": "Yesintek 45 mg Solution for injection", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1892/003", "product_name": "Yesintek 90 mg Solution for injection", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1892/004", "product_name": "Yesintek 130 mg Concentrate for solution for infusion", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1893/001-002", "product_name": "WELIREG 40 mg film-coated tablets", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX74" ], "active_substances": [ "Belzutifan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1894/001", "product_name": "Rytelo 47 mg powder for concentrate for solution for infusion", "holder": "Geron Netherlands B.V.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XX80" ], "active_substances": [ "Imetelstat sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1894/002", "product_name": "Rytelo 188 mg powder for concentrate for solution for infusion", "holder": "Geron Netherlands B.V.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01XX80" ], "active_substances": [ "Imetelstat sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1895/001", "product_name": "Eydenzelt 40 mg/mL solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Afibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1895/002", "product_name": "Eydenzelt 40 mg/mL solution for injection in a vial", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Afibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1896/001-006", "product_name": "Avtozma 20 mg/mL concentrate for solution for infusion", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1896/007-009", "product_name": "Avtozma 162 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1896/010-012", "product_name": "Avtozma 162 mg solution for injection in pre-filled pen", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AC07" ], "active_substances": [ "Tocilizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1897/001", "product_name": "Emcitate 350 microgram dispersible tablets", "holder": "Rare Thyroid Therapeutics International AB", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "H03AA04" ], "active_substances": [ "Tiratricol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1898/001", "product_name": "Lyvdelzi 10 mg hard capsules", "holder": "Cymabay Ireland Limited", "authorised_date": "2025-02-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AX07" ], "active_substances": [ "Seladelpar lysine dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1899/001-004", "product_name": "Zefylti 30 MU/0.5 mL solution for injection/infusion in pre-filled syringe", "holder": "Curateq Biologics s.r.o.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion in pre-filled syringe", "atc_codes": [ "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1899/005-008", "product_name": "Zefylti 48 MU/0.5 mL solution for injection/infusion in pre-filled syringe", "holder": "Curateq Biologics s.r.o.", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion in pre-filled syringe", "atc_codes": [ "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1900/001", "product_name": "KAVIGALE 300 mg solution for injection/infusion", "holder": "AstraZeneca AB", "authorised_date": "2025-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J06BD09" ], "active_substances": [ "Sipavibart" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1901/001-003", "product_name": "Nemluvio 30 mg powder and solvent for solution for injection in pre-filled pen", "holder": "Galderma International", "authorised_date": "2025-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection in pre-filled pen", "atc_codes": [ "D11AH12" ], "active_substances": [ "Nemolizumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1901/004", "product_name": "Nemluvio 30 mg powder and solvent for solution for injection in pre-filled 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"Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1902/002", "product_name": "Trabectedin Accord 1 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01CX01" ], "active_substances": [ "Trabectedin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1903/001-004", "product_name": "Eltrombopag Accord 12.5 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1903/005-010", "product_name": "Eltrombopag Accord 25 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1903/011-016", "product_name": "Eltrombopag Accord 50 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1903/017-022", "product_name": "Eltrombopag Accord 75 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1904/001-003", "product_name": "Osenvelt 120 mg solution for injection", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1905/001", "product_name": "Stoboclo 60 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1906/001", "product_name": "BEYONTTRA 356 mg film-coated tablets", "holder": "Bayer AG", "authorised_date": "2025-02-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB25" ], "active_substances": [ "Acoramidis hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic (abridged application) - art 10(1)" }, { "licence_number": "EU/1/24/1907/001", "product_name": "Tuzulby 20 mg prolonged-release chewable tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1907/002", "product_name": "Tuzulby 30 mg prolonged-release chewable tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1907/003", "product_name": "Tuzulby 40 mg prolonged-release chewable tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/001", "product_name": "Paxneury 1 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/002", "product_name": "Paxneury 2 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/003", "product_name": "Paxneury 3 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/004", "product_name": "Paxneury 4 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/005", "product_name": "Paxneury 5 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/006", "product_name": "Paxneury 6 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/24/1908/007", "product_name": "Paxneury 7 mg prolonged-release tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02AC02" ], "active_substances": [ "Guanfacine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1909/001", "product_name": "PAVBLU 40 mg/mL solution for injection in pre-filled syringe", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1909/002", "product_name": "PAVBLU 40 mg/mL solution for injection in a vial", "holder": "Amgen Technology (Ireland) Unlimited Company", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1911/001", "product_name": "Tivdak 40 mg powder for concentrate for solution for infusion", "holder": "Genmab A/S", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX23" ], "active_substances": [ "TISOTUMAB VEDOTIN" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1912/001", "product_name": "Voranigo 10 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XM04" ], "active_substances": [ "Vorasidenib hemicitrate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1912/002", "product_name": "Voranigo 40 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XM04" ], "active_substances": [ "Vorasidenib hemicitrate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1913/001-006", "product_name": "CAPVAXIVE solution for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (21-valent)", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2025-03-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J07AL02" ], "active_substances": [ "Pneumococcal Polysaccharide Serotype 3 Conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 6A Conjugated to CRM197", "Pneumococcal polysaccharide serotype 7F conjugated to CRM197", "Pneumococcal polysaccharide serotype 8 conjugated to CRM197", "Pneumococcal polysaccharide serotype 9N conjugated to CRM197", "Pneumococcal polysaccharide serotype 10A conjugated to CRM197", "Pneumococcal polysaccharide serotype 11A conjugated to CRM197", "Pneumococcal polysaccharide serotype 12F conjugated to CRM197", "Pneumococcal polysaccharide serotype 15A conjugated to CRM197", "Pneumococcal polysaccharide serotype 15B de-O-acetylated conjugated to CRM197", "Pneumococcal polysaccharide serotype 16F conjugated to CRM197", "Pneumococcal polysaccharide serotype 17F conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 19A Conjugated to CRM197", "Pneumococcal polysaccharide serotype 20A conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 22F Conjugated to CRM197", "Pneumococcal polysaccharide serotype 23B conjugated to CRM197", "Pneumococcal polysaccharide serotype 24F conjugated to CRM197", "Pneumococcal polysaccharide serotype 31 conjugated to CRM197", "Pneumococcal Polysaccharide Serotype 33F Conjugated to CRM197", "Pneumococcal polysaccharide serotype 35B conjugated to CRM197", "Pneumococcal polysaccharide serotype 23A conjugated to CRM197" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1914/001", "product_name": "Dyrupeg 6 mg solution for injection in pre-filled syringe", "holder": "Curateq Biologics s.r.o.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1915/001", "product_name": "Datroway 100 mg powder for concentrate for solution for infusion", "holder": "Daiichi Sankyo Europe GmbH", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX35" ], "active_substances": [ "Datopotamab deruxtecan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1916/001", "product_name": "VIMKUNYA suspension for injection in pre-filled syringe Chikungunya vaccine (recombinant, adsorbed)", "holder": "Bavarian Nordic A/S", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07BP02" ], "active_substances": [ "Chikungunya virus virus-like particle" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1917/001", "product_name": "LYNOZYFIC 5 mg concentrate for solution for infusion", "holder": "Regeneron Ireland Designated Activity Company", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [], "active_substances": [ "Linvoseltamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1917/002", "product_name": "LYNOZYFIC 200 mg concentrate for solution for infusion", "holder": "Regeneron Ireland Designated Activity Company", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [], "active_substances": [ "Linvoseltamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1918/001", "product_name": "Vyjuvek 5 x 10⁹ PFU/ml Suspension and gel for gel", "holder": "Krystal Biotech Netherlands B.V.", "authorised_date": "2025-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension and gel for gel", "atc_codes": [ "D03AX16" ], "active_substances": [ "Beremagene geperpavec" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1919/001-002", "product_name": "Deqsiga 100 mg/mL solution for infusion/human normal immunoglobulin (IVIg)", "holder": "Takeda Manufacturing Austria AG", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA02" ], "active_substances": [ "Human Normal Immunoglobulin (IV)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1920/001-002", "product_name": "Ryjunea 0.1 mg/ml eye drops, solution", "holder": "Santen OY", "authorised_date": "2025-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01FA01" ], "active_substances": [ "Atropine sulfate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1921/001-003", "product_name": "Jubereq 120 mg solution for injection", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1922/002", "product_name": "Osvyrti 60mg Solution for injection in pre-filled syringe", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-05-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1923/001", "product_name": "Xoanacyl 1 g film-coated tablets", "holder": "Averoa", "authorised_date": "2025-06-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE08" ], "active_substances": [ "Ferric citrate coordination complex" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1924/001", "product_name": "Imreplys 250 microgram powder for solution for injection", "holder": "Partner Therapeutics Limited", "authorised_date": "2025-08-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L03AA09" ], "active_substances": [ "Sargramostim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1925/001", "product_name": "Qoyvolma 45 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1925/002", "product_name": "Qoyvolma 90 mg solution for injection in pre-filled syringe", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1925/003", "product_name": "Qoyvolma 130 mg concentrate for solution for infusion", "holder": "Celltrion Healthcare Hungary Kft.", "authorised_date": "2025-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1926/001-002", "product_name": "Kisunla 350 mg concentrate for solution for infusion", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2025-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N06DX05" ], "active_substances": [ "Donanemab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1927/001-003", "product_name": "Winlevi 10 mg/g cream", "holder": "Cassiopea S.p.A.", "authorised_date": "2025-10-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AX06" ], "active_substances": [ "Clascoterone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1928/001-002", "product_name": "Aqneursa 1 g granules for oral suspension in sachet", "holder": "Intrabio Ireland Limited", "authorised_date": "2026-01-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral suspension in sachet", "atc_codes": [ "N07XX27" ], "active_substances": [ "L-Acetylleucine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1929/001", "product_name": "Attrogy 250 mg film-coated tablets", "holder": "AO Pharma AB", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BA11" ], "active_substances": [ "Diflunisal" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1930/001", "product_name": "Duvyzat 8.86 mg/ml oral suspension", "holder": "Italfarmaco S.p.A.", "authorised_date": "2025-06-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M09AX14" ], "active_substances": [ "Givinostat hydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1931/001-002", "product_name": "Ziihera 300 mg powder for concentrate for solution for infusion", "holder": "Jazz Pharmaceuticals Ireland Limited", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD07" ], "active_substances": [ "Zanidatamab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1932/001-002", "product_name": "Ogsiveo 50 mg film‑coated tablets", "holder": "Merck Europe B.V.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX81" ], "active_substances": [ "Nirogacestat hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1932/003", "product_name": "Ogsiveo 100 mg film‑coated tablets", "holder": "Merck Europe B.V.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX81" ], "active_substances": [ "Nirogacestat hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1932/004", "product_name": "Ogsiveo 150 mg film‑coated tablets", "holder": "Merck Europe B.V.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XX81" ], "active_substances": [ "Nirogacestat hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1933/001", "product_name": "Junod 60 mg solution for injection in pre-filled syringe", "holder": "Gedeon Richter Plc", "authorised_date": "2025-06-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1934/001-003", "product_name": "Yaxwer 120 mg solution for injection", "holder": "Gedeon Richter Plc", "authorised_date": "2025-06-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1935/001", "product_name": "Izamby 60 mg solution for injection in pre-filled syringe", "holder": "Mabxience Research, S.L.", "authorised_date": "2025-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1936/001", "product_name": "Denbrayce 120 mg solution for injection", "holder": "Mabxience Research, S.L.", "authorised_date": "2025-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1937/001", "product_name": "ZADENVI 60 mg solution for injection in pre-filled syringe", "holder": "Zentiva k.s.", "authorised_date": "2025-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1938/001", "product_name": "Oczyesa 20 mg prolonged-release solution for injection in pre-filled pen", "holder": "Camurus AB", "authorised_date": "2025-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release solution for injection", "atc_codes": [ "H01CB02" ], "active_substances": [ "Octreotide hydrochloride" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1939/001", "product_name": "Sephience 250 mg oral powder in sachet", "holder": "PTC Therapeutics International Limited", "authorised_date": "2025-06-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in sachet", "atc_codes": [ "A16AX28" ], "active_substances": [ "Sepiapterin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1939/002", "product_name": "Sephience 1 000 mg oral powder in sachet", "holder": "PTC Therapeutics International Limited", "authorised_date": "2025-06-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral powder in sachet", "atc_codes": [ "A16AX28" ], "active_substances": [ "Sepiapterin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1941/001", "product_name": "TEPEZZA 500 mg powder for concentrate for solution for infusion", "holder": "Amgen Europe B.V.,", "authorised_date": "2025-06-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AG13" ], "active_substances": [ "Teprotumumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1942/001", "product_name": "Itovebi 3 mg film-coated tablets", "holder": "Roche Registration GmbH", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EM06" ], "active_substances": [ "Inavolisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1942/002", "product_name": "Itovebi 9 mg film-coated tablets", "holder": "Roche Registration GmbH", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EM06" ], "active_substances": [ "Inavolisib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1943/001", "product_name": "Alyftrek 50 mg/20 mg/4 mg film-coated tablets", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2025-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX33" ], "active_substances": [ "Vanzacaftor", "TEZACAFTOR", "Deutivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1943/002", "product_name": "Alyftrek 125 mg/50 mg/10 mg film-coated tablets", "holder": "Vertex Pharmaceuticals (Ireland) Limited", "authorised_date": "2025-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R07AX33" ], "active_substances": [ "Vanzacaftor", "TEZACAFTOR", "Deutivacaftor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1944/001", "product_name": "Enwylma 120 mg solution for injection", "holder": "Zentiva k.s.", "authorised_date": "2025-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1945/001-003", "product_name": "Vevzuo 120 mg solution for injection", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2025-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1946/001", "product_name": "Evfraxy 60 mg solution for injection in pre-filled syringe", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2025-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1947/001-002", "product_name": "RIULVY 174 mg gastro-resistant hard capsules", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-07-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX10" ], "active_substances": [ "Tegomil fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1947/001-002", "product_name": "RIULVY 174 mg gastro-resistant hard capsules", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-07-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX10" ], "active_substances": [ "Tegomil fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1947/003-005", "product_name": "RIULVY 348 mg gastro-resistant hard capsules", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "2025-07-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX10" ], "active_substances": [ "Tegomil fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 13(3) of Directive No 2001/82/EC)" }, { "licence_number": "EU/1/25/1948/001", "product_name": "BLENREP 70 mg powder for concentrate for solution for infusion", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2025-07-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX15" ], "active_substances": [ "Belantamab Mafodotin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1948/002", "product_name": "BLENREP 100 mg powder for concentrate for solution for infusion", "holder": "GlaxoSmithKline Trading Services Limited", "authorised_date": "2025-07-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FX15" ], "active_substances": [ "Belantamab Mafodotin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1949/001", "product_name": "Dazublys 150 mg powder for concentrate for solution for infusion", "holder": "Curateq Biologics s.r.o.", "authorised_date": "2025-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01FD01" ], "active_substances": [ "Trastuzumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1950/001-002", "product_name": "Ezmekly 1 mg dispersible tablets", "holder": "Merck Europe B.V.", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "L01EE05" ], "active_substances": [ "Mirdametinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1950/003", "product_name": "Ezmekly 1 mg hard capsules", "holder": "Merck Europe B.V.", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EE05" ], "active_substances": [ "Mirdametinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1950/004-005", "product_name": "Ezmekly 2 mg hard capsules", "holder": "Merck Europe B.V.", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EE05" ], "active_substances": [ "Mirdametinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1951/001", "product_name": "Aucatzyl 410 × 106 cells dispersion for infusion", "holder": "Autolus GmbH", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "L01XL12" ], "active_substances": [ "Obecabtagene autoleucel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1952/001-002", "product_name": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR17" ], "active_substances": [ "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1952/003-008", "product_name": "Emtricitabine/Tenofovir alafenamide Viatris 200 mg/25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR17" ], "active_substances": [ "Emtricitabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1953/01-03", "product_name": "BOMYNTRA 120 mg solution for injection in vial", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1953/04-06", "product_name": "BOMYNTRA 120 mg solution for injection in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1954/01", "product_name": "Conexxence 60 mg solution for injection in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1955/001", "product_name": "Maapliv solution for infusion", "holder": "Recordati Rare Diseases", "authorised_date": "2025-07-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA01" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Cysteine hydrochloride monohydrate", "Glutamic acid", "Glycine", "Histidine", "Lysine monohydrate", "Methionine", "Phenylalanine", "Proline", "Serine", "Taurine", "Threonine", "Tryptophan", "Tyrosine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1956/001", "product_name": "Austedo 36 mg prolonged-release tablets Austedo 42 mg prolonged-release tablets Austedo 48 mg prolonged-release tablets", "holder": "TEVA GmbH", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX16" ], "active_substances": [ "Deutetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1956/002-003", "product_name": "Austedo 24 mg prolonged-release tablets", "holder": "TEVA GmbH", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX16" ], "active_substances": [ "Deutetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1956/004-005", "product_name": "Austedo 30 mg prolonged-release tablets", "holder": "TEVA GmbH", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX16" ], "active_substances": [ "Deutetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1956/006-007", "product_name": "Austedo 36 mg prolonged-release tablets", "holder": "TEVA GmbH", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX16" ], "active_substances": [ "Deutetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1956/008-009", "product_name": "Austedo 42 mg prolonged-release tablets", "holder": "TEVA GmbH", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX16" ], "active_substances": [ "Deutetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1956/010-011", "product_name": "Austedo 48 mg prolonged-release tablets", "holder": "TEVA GmbH", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX16" ], "active_substances": [ "Deutetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1957/001", "product_name": "Usymro 45 mg solution for injection", "holder": "Gedeon Richter Plc", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1957/002", "product_name": "Usymro 45 mg solution for injection in pre-filled syringe", "holder": "Gedeon Richter Plc", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1957/003", "product_name": "Usymro 90 mg solution for injection in pre-filled syringe", "holder": "Gedeon Richter Plc", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1957/004", "product_name": "Usymro 130 mg concentrate for solution for infusion", "holder": "Gedeon Richter Plc", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1958/001", "product_name": "Rolcya 60 mg solution for injection in pre-filled syringe", "holder": "Sandoz GmbH", "authorised_date": "2025-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1959/001-002", "product_name": "Nintedanib Viatris 100 mg soft capsules", "holder": "Viatris Limited", "authorised_date": "2025-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1959/003-004", "product_name": "Nintedanib Viatris 150 mg soft capsules", "holder": "Viatris Limited", "authorised_date": "2025-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1960/001", "product_name": "Zemcelpro ≥ 0.23×106 viable CD34+ cells/mL/≥ 0.53×106 viable CD3+ cells/mL dispersion for infusion", "holder": "Cordex Biologics International Limited", "authorised_date": "2025-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "B05AX04" ], "active_substances": [ "Haematopoietic stem cells and blood progenitor umbilical cord-derived expanded with (1R, 4R)-N1-(2-benzyl-7-(2-methyl-2H-tetrazol-5-yl)-9H-pyrimido[4,5-b]indol-4-yl)cyclohexane-1,4-diamine dihydrobromide dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1961/001", "product_name": "Vgenfli 40 mg/mL solution for injection in pre-filled syringe", "holder": "Zaklady Farmaceutyczne Polpharma S.A.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1961/002", "product_name": "Vgenfli 40 mg/mL solution for injection in a vial", "holder": "Zaklady Farmaceutyczne Polpharma S.A.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1962/001", "product_name": "Rezdiffra 60 mg film-coated tablets", "holder": "Madrigal Pharmaceuticals EU Limited", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05BA11" ], "active_substances": [ "Resmetirom" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1962/002", "product_name": "Rezdiffra 80 mg film-coated tablets", "holder": "Madrigal Pharmaceuticals EU Limited", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05BA11" ], "active_substances": [ "Resmetirom" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1962/003", "product_name": "Rezdiffra 100 mg film-coated tablets", "holder": "Madrigal Pharmaceuticals EU Limited", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05BA11" ], "active_substances": [ "Resmetirom" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1963/001", "product_name": "Eiyzey 40 mg/mL solution for injection in pre-filled syringe", "holder": "Zaklady Farmaceutyczne Polpharma S.A.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1963/002", "product_name": "Eiyzey 40 mg/mL solution for injection in a vial", "holder": "Zaklady Farmaceutyczne Polpharma S.A.", "authorised_date": "2025-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1964/001", "product_name": "MYNZEPLI 40 mg/mL solution for injection in a vial", "holder": "Advanz Pharma Limited", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1964/002", "product_name": "MYNZEPLI 40 mg/mL solution for injection in pre-filled syringe", "holder": "Advanz Pharma Limited", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1965/001", "product_name": "Afiveg 40 mg/mL solution for injection", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1965/002", "product_name": "Afiveg 40 mg/mL solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1966/001-006", "product_name": "Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris 200 mg/25 mg/25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2025-08-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR19" ], "active_substances": [ "Emtricitabine", "Rilpivirine", "Tenofovir alafenamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1967/001-002", "product_name": "Vivlipeg 6 mg solution for injection in pre-filled syringe", "holder": "Biosimilar Collaborations Ireland Limited", "authorised_date": "2025-08-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AA13" ], "active_substances": [ "Pegfilgrastim" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1968/001", "product_name": "ROMVIMZA 14 mg hard capsules", "holder": "Deciphera Pharmaceuticals (Netherlands) B.V.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX29" ], "active_substances": [ "Vimseltinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1968/002", "product_name": "ROMVIMZA 20 mg hard capsules", "holder": "Deciphera Pharmaceuticals (Netherlands) B.V.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX29" ], "active_substances": [ "Vimseltinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1968/003", "product_name": "ROMVIMZA 30 mg hard capsules", "holder": "Deciphera Pharmaceuticals (Netherlands) B.V.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX29" ], "active_substances": [ "Vimseltinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1970/001-008", "product_name": "Macitentan Accord 10 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1971/001-008", "product_name": "Macitentan AccordPharma 10 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2025-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1972/001", "product_name": "Eyluxvi 40mg/ml Solution for injection in vial", "holder": "Biolitec Pharma Limited", "authorised_date": "2025-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA05" ], "active_substances": [ "Aflibercept" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1973/001", "product_name": "Usrenty 45 mg solution for injection", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1973/002", "product_name": "Usrenty 45 mg solution for injection in pre-filled syringe", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1973/003", "product_name": "Usrenty 90 mg solution for injection in pre-filled syringe", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1973/004", "product_name": "Usrenty 130 mg concentrate for solution for infusion", "holder": "Biocon Biologics Ireland Limited", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1974/001-003", "product_name": "WAYRILZ 400 mg film-coated tablets", "holder": "Sanofi B.V.", "authorised_date": "2025-12-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [ "Rilzabrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1975/001-002", "product_name": "Ekterly 300 mg film-coated tablets", "holder": "Kalvista Pharmaceuticals (Ireland) Limited", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B06AC08" ], "active_substances": [ "Sebetralstat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1976/001", "product_name": "Yeytuo 300 mg film-coated tablets", "holder": "Gilead Sciences Ireland Unlimited Company", "authorised_date": "2025-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AX31" ], "active_substances": [ "Lenacapavir sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1976/002", "product_name": "Yeytuo 464 mg solution for injection", "holder": "Gilead Sciences Ireland Unlimited Company", "authorised_date": "2025-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J05AX31" ], "active_substances": [ "Lenacapavir sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1977/001-003", "product_name": "Zurzuvae 20 mg hard capsules", "holder": "Biogen Netherlands B.V.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX31" ], "active_substances": [ "Zuranolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1977/004-006", "product_name": "Zurzuvae 25 mg hard capsules", "holder": "Biogen Netherlands B.V.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX31" ], "active_substances": [ "Zuranolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1977/007", "product_name": "Zurzuvae 30 mg hard capsules", "holder": "Biogen Netherlands B.V.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX31" ], "active_substances": [ "Zuranolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1978/001", "product_name": "Bildyos 60 mg solution for injection in pre-filled syringe", "holder": "Sciencepharma Sp. z o.o.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1978/002", "product_name": "Bildyos 60 mg solution for injection", "holder": "Sciencepharma Sp. z o.o.", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1979/001", "product_name": "Bilprevda 120 mg solution for injection", "holder": "Henlius Europe GmbH", "authorised_date": "2025-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1980/001", "product_name": "Kefdensis 60 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1981/001-003", "product_name": "Zvogra 120 mg solution for injection", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1982/001-004", "product_name": "Xbonzy 120 mg solution for injection", "holder": "Reddy Holding GmbH", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1983/001", "product_name": "Acvybra 60 mg solution for injection in pre-filled syringe", "holder": "Reddy Holding GmbH", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1984/001-007", "product_name": "Enflonsia 105 mg solution for injection in pre-filled syringe", "holder": "Merck Sharp & Dohme BV,", "authorised_date": "2026-04-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J06BD10" ], "active_substances": [ "Clesrovimab" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1985/001-002", "product_name": "Degevma 120 mg solution for injection", "holder": "TEVA GmbH", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1986/001", "product_name": "Ponlimsi 60 mg solution for injection in pre-filled syringe", "holder": "TEVA GmbH", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1987/001", "product_name": "Usgena 45 mg solution for injection", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1987/002", "product_name": "Usgena 45 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1987/003-004", "product_name": "Usgena 90 mg solution for injection in pre-filled syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1987/005", "product_name": "Usgena 130 mg concentrate for solution for infusion", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AC05" ], "active_substances": [ "Ustekinumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1988/001-002", "product_name": "GOBIVAZ 50 mg solution for injection in pre-filled pen", "holder": "Advanz Pharma Limited", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1988/003-004", "product_name": "GOBIVAZ 50 mg solution for injection in pre-filled syringe", "holder": "Advanz Pharma Limited", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1988/005-006", "product_name": "GOBIVAZ 100 mg solution for injection in pre-filled pen", "holder": "Advanz Pharma Limited", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1988/007-008", "product_name": "GOBIVAZ 100 mg solution for injection in pre-filled syringe", "holder": "Advanz Pharma Limited", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB06" ], "active_substances": [ "Golimumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1989/001-002", "product_name": "Imaavy 185 mg/mL concentrate for solution for infusion", "holder": "Janssen-Cilag International NV", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AL03" ], "active_substances": [ "Nipocalimab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1990/001-003", "product_name": "Enzalutamide Accordpharma 40 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1990/004-008", "product_name": "Enzalutamide Accordpharma 80 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1990/009-017", "product_name": "Enzalutamide Accordpharma 160 mg film-coated tablets", "holder": "Accord Healthcare S.L.U.", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1991/001-003", "product_name": "Lynkuet 60 mg soft capsules", "holder": "Bayer AG", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G02CX07" ], "active_substances": [ "Elinzanetant" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1992/001-006", "product_name": "Kyinsu (700 units + 2 mg)/mL solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2025-11-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE57" ], "active_substances": [ "Insulin icodec", "Semaglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1993/001", "product_name": "Vysribli (previously known as Denosumab Intas) 60 mg solution for injection in pre-filled syringe", "holder": "Intas Third Party Sales 2005 S.L.", "authorised_date": "2025-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1994/001-002", "product_name": "Rivaroxaban Koanaa 10 mg Orodispersible film", "holder": "Koanaa Healthcare Spain S.L.", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible film", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1994/003-004", "product_name": "Rivaroxaban Koanaa 15 mg Orodispersible film", "holder": "Koanaa Healthcare Spain S.L.", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible film", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1994/005-006", "product_name": "Rivaroxaban Koanaa 20 mg Orodispersible film", "holder": "Koanaa Healthcare Spain S.L.", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible film", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1995/001", "product_name": "Brinsupri 25 mg film-coated tablets", "holder": "Insmed Netherlands B.V.", "authorised_date": "2025-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03" ], "active_substances": [ "Brensocatib monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1996/001", "product_name": "Waskyra 2-10 × 106 cells/mL dispersion for infusion", "holder": "Fondazione Telethon Ets", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersion for infusion", "atc_codes": [ "B06" ], "active_substances": [ "Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-Aldrich syndrome protein" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1997/001", "product_name": "Osqay 60 mg solution for injection in pre-filled syringe", "holder": "Theramex Ireland Limited", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M05BX04" ], "active_substances": [ "Denosumab" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1998/001-003", "product_name": "Teizeild 1 mg/mL concentrate for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "A10XX01" ], "active_substances": [ "Teplizumab" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/1999/001", "product_name": "VacPertagen suspension for injection in pre-filled syringe Pertussis vaccine (recombinant, acellular, component, adsorbed)", "holder": "Bionet Europe", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AJ02" ], "active_substances": [ "PERTUSSIS FILAMENTOUS HAEMAGGLUTININ" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/2000/001-003", "product_name": "Ondibta 100 units/ml solution for injection in pre-filled pen", "holder": "Sandoz GmbH", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AE04" ], "active_substances": [ "Insulin glargine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "*** AWAITING VALUE ***" ], "supply_status": "", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/2001/001-002", "product_name": "Dawnzera 80mg solution for injection in pre-filled pen", "holder": "Otsuka Pharmaceutical Netherlands B.V.", "authorised_date": "2026-01-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "B06AC09" ], "active_substances": [ "Donidalorsen sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/2002/001", "product_name": "Anktiva 400µg/0.4 ml Intravesical solution", "holder": "Serum Life Science Europe GmbH", "authorised_date": "2026-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Intravesical solution", "atc_codes": [ "L03AC03" ], "active_substances": [ "Nogapendekin alfa", "Inbakicept" ], "routes": [ "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/2003/001-006", "product_name": "Inluriyo 200 mg film-coated tablets", "holder": "Eli Lilly and Company Limited", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BA" ], "active_substances": [ "Imlunestrant 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"GalenVita 1.11 GBq radionuclide generator", "holder": "Monrol Europe S.R.L.", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Radionuclide generator", "atc_codes": [ "V09X" ], "active_substances": [ "GERMANIUM (68GE) CHLORIDE", "Gallium (68Ga) Chloride" ], "routes": [ "Route of administration not applicable" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/25/2004/003", "product_name": "GalenVita 1.48 GBq radionuclide generator", "holder": "Monrol Europe S.R.L.", "authorised_date": "2026-01-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Radionuclide generator", "atc_codes": [ "V09X" ], "active_substances": [ "GERMANIUM (68GE) CHLORIDE", 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"EU/1/26/2024/001-003", "product_name": "Rhapsido 25 mg film-coated tablets", "holder": "Novartis Europharm Limited", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA60" ], "active_substances": [ "Remibrutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2026/001", "product_name": "Onerji (60 mg + 7.5 mg)/mL solution for infusion", "holder": "Mitsubishi Tanabe Pharma GmbH", "authorised_date": "2026-04-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2028/001-002", "product_name": "mCOMBRIAX dispersion for injection in pre-filled syringe. 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"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2036/001-003", "product_name": "Ablymico 6 mg/mL solution for injection in pre-filled pen", "holder": "Stada Arzneimittel AG", "authorised_date": "2026-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ02" ], "active_substances": [ "Liraglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2037/001-005", "product_name": "Liraglutide STADA 6 mg/ml solution for injection in pre-filled pen", "holder": "Stada Arzneimittel AG", "authorised_date": "2026-07-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ02" ], "active_substances": [ "Liraglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2038/001", "product_name": "Itvisma 1.2 × 1014 vector genomes solution for injection", "holder": "Novartis Europharm Limited", "authorised_date": "2026-06-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M09AX09" ], "active_substances": [ "Onasemnogene Abeparvovec" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full 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"licence_number": "EU/1/26/2044/001", "product_name": "Boey 1 400 units powder for solution for injection", "holder": "AbbVie Deutschland GmbH & Co. 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"Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2047/001", "product_name": "Vislyfa 10 mg/mL solution for injection", "holder": "Lupin Europe GmbH", "authorised_date": "2026-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "S01LA04" ], "active_substances": [ "Ranibizumab" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2047/002", "product_name": "Vislyfa 10 mg/mL solution for injection in pre-filled syringe", "holder": "Lupin Europe GmbH", "authorised_date": "2026-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": 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"licence_number": "EU/1/26/2054/001", "product_name": "Hopledo 140 mg/35 mg modified-release hard capsules", "holder": "Zambon S.p.A.", "authorised_date": "2026-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N04BA02" ], "active_substances": [ "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2054/002", "product_name": "Hopledo 210 mg/52.5 mg modified-release hard capsules", "holder": "Zambon S.p.A.", "authorised_date": "2026-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N04BA02" ], "active_substances": [ "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2054/003", "product_name": "Hopledo 280 mg/70 mg modified-release hard capsules", "holder": "Zambon S.p.A.", "authorised_date": "2026-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N04BA02" ], "active_substances": [ "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/26/2054/004", "product_name": "Hopledo 350 mg/87.5 mg modified-release hard capsules", "holder": "Zambon S.p.A.", "authorised_date": "2026-08-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N04BA02" ], "active_substances": [ "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/001/021", "product_name": "Gonal-F 1050 IU/1.75 mL powder and solvent for solution for injection", "holder": "Merck Europe B.V.", "authorised_date": "2001-01-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/001/025", "product_name": "Gonal-F", "holder": "Merck Europe B.V.", "authorised_date": "2002-06-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/001/026", "product_name": "Gonal-F", "holder": "Merck Europe B.V.", "authorised_date": "2002-06-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/001/027", "product_name": "Gonal-F", "holder": "Merck Europe B.V.", "authorised_date": "2002-06-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to 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2001/83/EC)" }, { "licence_number": "EU/1/95/001/033", "product_name": "Gonal-F 300 IU/0.48 mL solution for injection in pre-filled pen", "holder": "Merck Europe B.V.", "authorised_date": "2004-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/001/034", "product_name": "Gonal-F 450 IU/0.72 mL solution for injection in pre-filled pen", "holder": "Merck Europe B.V.", "authorised_date": "1995-10-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA", "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/001/035", "product_name": "GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen", "holder": "Merck Europe B.V.", "authorised_date": "1995-10-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA05" ], "active_substances": [ "Follitropin alfa" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/002/001", "product_name": "Taxotere 20 mg/0.5 ml Concentrate and solvent for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CD", "L01CD02" ], "active_substances": [ "Docetaxel trihydrate" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/002/002", "product_name": "Taxotere 80 mg/2 ml Concentrate and solvent for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "1995-11-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate and solvent for solution for infusion", "atc_codes": [ "L01CD", "L01CD02" ], "active_substances": [ "Docetaxel trihydrate" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/002/003", "product_name": "Taxotere 20 mg/1 ml Concentrate and solvent for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2009-11-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate and solvent for solution for infusion", "atc_codes": [ "L01CD", "L01CD02" ], "active_substances": [ "Docetaxel trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/002/004", "product_name": "Taxotere 80 mg/4 ml Concentrate and solvent for solution for infusion", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2009-11-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate and solvent for solution for infusion", "atc_codes": [ "L01CD", "L01CD02" ], "active_substances": [ "Docetaxel trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/95/003/005-012", "product_name": "Betaferon 250 microgram/ml, powder and solvent for solution for injection", "holder": "Schering AG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L03AB", "L03AB08" ], 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"1996-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02BA", "L02BA02" ], "active_substances": [ "Toremifene" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/001", "product_name": "CellCept 250 mg Capsule, hard", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/002", "product_name": "CellCept 500 mg Film-coated tablet", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/003", "product_name": "CellCept 250 mg Capsule, hard", "holder": "Roche Registration GmbH", "authorised_date": "1997-05-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/004", "product_name": "CellCept 500 mg Film-coated tablet", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/005", "product_name": "CellCept 500 mg Powder for concentrate for solution for infusion", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/006", "product_name": "CellCept 1 g/5 ml Powder for oral suspension", "holder": "Roche Registration GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/005/007", "product_name": "CellCept 250 mg hard capsules", "holder": "Roche Registration GmbH", "authorised_date": "1996-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/006/004", "product_name": "NovoSeven (50 KIU)", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD08" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/006/005", "product_name": "NovoSeven (100 KIU)", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD08" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/006/006", "product_name": "NovoSeven (250 KIU)", "holder": "Novo Nordisk A/S", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD08" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/006/007", "product_name": "NovoSeven (400 KIU)", "holder": "Novo Nordisk A/S", "authorised_date": "1996-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product 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"AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD08" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/006/010", "product_name": "NovoSeven (250 KIU)", "holder": "Novo Nordisk A/S", "authorised_date": "2008-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD08" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/006/011", "product_name": "Novoseven (400 KIU)", "holder": "Novo Nordisk A/S", "authorised_date": "2008-04-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD08" ], "active_substances": [ "Eptacog alfa (activated)" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/007/002", "product_name": "Humalog 100 units/ml solution for injection in vial", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "1996-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/007/004", "product_name": "Humalog 100 units/ml solution for injection in cartridge insulin lispro", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "1997-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/007/005", "product_name": "Humalog Mix25 100 units/ml suspension for 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"registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD" ], "active_substances": [ "Insulin lispro" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/007/019", "product_name": "Humalog", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2001-12-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [ "Insulin lispro" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/007/039-042", "product_name": "Humalog 200 units/ml KwikPen solution for injection in a pre-filled pen", "holder": "Eli Lilly and Company Limited", "authorised_date": "2014-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A10AB", "A10AB04" ], "active_substances": [], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/008/017", "product_name": "Puregon", "holder": "N.V. 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application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/011/001-004", "product_name": "Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1996-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01DB", "L01DB01" ], "active_substances": [ "DOXORUBICIN HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/012/004", "product_name": "Bondronat 2 mg concentrate for solution for infusion.", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "M05BA" ], "active_substances": [ "Ibandronic acid monosodium monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/012/009-010", "product_name": "Bondronat 50 mg film-coated tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/015/002", "product_name": "Epivir 10 mg/ml oral solution", "holder": "ViiV Healthcare BV", "authorised_date": "1996-08-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "J05A" ], "active_substances": [ "Lamivudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/015/003", "product_name": "Epivir 300 mg film-coated tablets", "holder": "ViiV Healthcare BV", "authorised_date": "2001-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF", "J05AF05" ], "active_substances": [ "Lamivudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/016/005-006", "product_name": "Norvir 100 mg film-coated tablets", "holder": "AbbVie Deutschland GmbH & Co. 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/020/001", "product_name": "Twinrix Adult, suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)", "holder": "SmithKline Beecham Biologicals", "authorised_date": "1996-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC20" ], "active_substances": [ "Hepatitis a vaccine", "Hepatitis b surface antigen, recominant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/020/002", "product_name": "Twinrix 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"1996-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC20" ], "active_substances": [ "Hepatitis a vaccine", "Hepatitis b surface antigen, recominant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/96/020/004", "product_name": "Twinrix Adult", "holder": "SmithKline Beecham Biologicals", "authorised_date": "1996-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07BC", "J07BC20" ], "active_substances": [ "Hepatitis a vaccine", "Hepatitis b surface antigen, recominant" ], "routes": [ "Intramuscular use" ], "dispensing_status": 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"licence_number": "EU/1/98/071/004", "product_name": "Xenical 120 mg hard capsules", "holder": "Cheplapharm Arzneimittel GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A08AB", "A08AB01" ], "active_substances": [ "Orlistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/98/071/005", "product_name": "Xenical 120 mg hard capsules", "holder": "Cheplapharm Arzneimittel GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A08AB", "A08AB01" ], "active_substances": [ "Orlistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"product_name": "Prometax 4.5 mg hard capsules", "holder": "Almirall, S.A.", "authorised_date": "1998-12-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06DA", "N06DA03" ], "active_substances": [ "Rivastigmine hydrogen tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/98/092/010-012", "product_name": "Prometax 6.0 mg hard capsules", "holder": "Almirall, S.A.", "authorised_date": "1998-12-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06DA", "N06DA03" ], "active_substances": [ "Rivastigmine hydrogen tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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{ "licence_number": "EU/1/98/092/23-26", "product_name": "Prometax 9.5 mg/24 h transdermal patch", "holder": "Almirall, S.A.", "authorised_date": "2007-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N06DA", "N06DA03" ], "active_substances": [ "Rivastigmine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/98/095/001", "product_name": "EMADINE 0.5 mg/ml, eye drops, solution", "holder": "Immedica Pharma AB", "authorised_date": "1999-01-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX06" ], "active_substances": [ "Emedastine difumarate" ], "routes": [ "Ocular use" ], 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"New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/118/008", "product_name": "Arava 20 mg Film-coated tablet", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [ "Leflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/118/009", "product_name": "Arava 100 mg Film-coated tablet", "holder": "Sanofi-Aventis Deutschland GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [ "Leflunomide" ], "routes": [ "Oral use" 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"1999-09-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AB", "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/119/009-011", "product_name": "NovoRapid FlexPen 100 U/ml Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "1999-09-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AB", "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/119/012-014", "product_name": "NovoRapid InnoLet 100 U/ml Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2003-06-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10AB", "A10AB05" ], "active_substances": [ "Insulin aspart" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/119/019", "product_name": "NovoRapid FlexTouch 100 U/ml Solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "2004-08-24", "product_type": "HM", "market_status": "Unknown", 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"EU/1/99/122/002", "product_name": "Thyrogen 0.9 mg Powder for solution for injection", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2000-03-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "H01AB01" ], "active_substances": [ "Thyrotropin alfa" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/123/005-007", "product_name": "Renagel 400 mg Film-coated tablet", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2001-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE" ], "active_substances": [ "Sevelamer" ], "routes": [ "Oral use" ], 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE02" ], "active_substances": [ "Sevelamer" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/123/008-013", "product_name": "Renagel 800 mg Film-coated tablet", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2001-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE" ], "active_substances": [ "Sevelamer" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/123/009", "product_name": "Renagel", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2001-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE02" ], "active_substances": [ "Sevelamer" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/123/010", "product_name": "Renagel", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2001-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE02" ], "active_substances": [ "Sevelamer" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/123/011-013", "product_name": "Renagel", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2001-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE02" ], "active_substances": [ "Sevelamer" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/124/001", "product_name": "Tractocile 6.75 mg/0.9 ml Solution for injection", "holder": "Ferring AB", "authorised_date": "2000-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G02CX", "G02CX01" ], "active_substances": [ "Atosiban acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/124/002", "product_name": "Tractocile 37.5 mg/ 5 ml Concentrate for solution for infusion", "holder": "Ferring AB", "authorised_date": "2000-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G02CX", "G02CX01" ], "active_substances": [ "Atosiban acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/125/001", "product_name": "Zyprexa Velotab 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prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/125/003", "product_name": "Zyprexa Velotab 15 mg Orodispersible tablet", "holder": "Cheplapharm Registration GmbH", "authorised_date": "2000-02-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/125/004", "product_name": "Zyprexa Velotab 20 mg Orodispersible tablet", "holder": "Cheplapharm Registration GmbH", "authorised_date": "2000-02-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/126/001-003", "product_name": "Enbrel 25 mg Powder for solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/126/002", "product_name": "Enbrel 25 mg Powder for solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2006-08-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/126/013-015", "product_name": "Enbrel 25 mg Solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2006-09-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/126/016-021", "product_name": "Enbrel 50 mg Solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2006-09-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/126/022", "product_name": "Enbrel 10 mg Powder and solvent for solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/126/023-025", "product_name": "Enbrel 25 mg Solution for injection", "holder": "Pfizer Europe MA EEIG", "authorised_date": "2005-04-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L04AB", "L04AB01" ], "active_substances": [ "Etanercept" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/1/99/128/015", "product_name": "Viraferon", "holder": "Schering Plough Europe", "authorised_date": "2000-03-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [], "active_substances": [ "Interferon alfa-2b" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "EU/120/1490/013-015", "product_name": "Lenalidomide Mylan 20 mg hard capsules", "holder": "Mylan IRE Healthcare Limited", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "HOA1149/001/001", "product_name": "Colica Colic Granules", "holder": "A. Nelson & Company Limited", "authorised_date": "2019-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [], "active_substances": [ "CITRULLUS COLOCYNTHIS 30C HAP/PH.EUR", "Dioscorea villosa" ], "routes": [], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "National Rules Authorisation (Article 16.2 Directive 2001/83/EC.)" }, { "licence_number": "HOA1149/003/001", "product_name": "Noctura 6C tablets", "holder": "A. Nelson & Company Limited", "authorised_date": "2020-05-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [ "Valeriana officinalis", "Potassium bromide", "Passiflora incarnata", "Coffea arabica" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "National Rules Authorisation (Article 16.2 Directive 2001/83/EC.)" }, { "licence_number": "HOA1149/004/001", "product_name": "Travella 6C tablets", "holder": "A. 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Nelson & Company Limited", "authorised_date": "2018-11-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [], "active_substances": [ "Rhus toxicodendron" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "National Rules Authorisation (Article 16.2 Directive 2001/83/EC.)" }, { "licence_number": "HOA23352/001/001", "product_name": "Teetha Teething Granules", "holder": "Pharmaceutical Business Consultants Limited", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [], "active_substances": [ "Chamomilla recutita" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "National Rules Authorisation (Article 16.2 Directive 2001/83/EC.)" }, { "licence_number": "HOA23352/002/001", "product_name": "Teetha Chamomilla Teething Gel", "holder": "Pharmaceutical Business Consultants Limited", "authorised_date": "2022-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [], "active_substances": [ "Chamomilla 12c hab" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "", "legal_basis": "National Rules Authorisation (Article 16.2 Directive 2001/83/EC.)" }, { "licence_number": "HOA23352/003/001", "product_name": "Nelsons Arnicare Arnica Cream", "holder": "Pharmaceutical Business Consultants Limited", "authorised_date": "2018-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [], "active_substances": [ "Arnica montana" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "National Rules Authorisation (Article 16.2 Directive 2001/83/EC.)" }, { "licence_number": "HOR0407/016/001", "product_name": "Nux vomica - Tablets", "holder": "Weleda (UK) Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [ "Strychnos nux-vomica" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC)" }, { "licence_number": "HOR0407/018/001", "product_name": "Chamomilla - Tablets", "holder": "Weleda (UK) Limited", "authorised_date": "", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [ "Chamomilla recutita" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC)" }, { "licence_number": "HOR0652/001/001", "product_name": "Nat. mur. 6X", "holder": "New Vistas Healthcare Ltd", "authorised_date": "2017-04-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [], "active_substances": [ "Nat mur 6x" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC)" }, { "licence_number": "HOR1149/001/001", "product_name": "Aconite", "holder": "A. 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Nelson & Company Limited", "authorised_date": "2011-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [], "active_substances": [ "Gelsemium sempervirens" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR1149/013/001", "product_name": "GRAPHITES", "holder": "A. Nelson & Company Limited", "authorised_date": "2011-04-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [], "active_substances": [ "Graphites" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR1149/015/001", "product_name": "Hypericum", "holder": "A. Nelson & Company Limited", "authorised_date": "2010-10-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pillules", "atc_codes": [], "active_substances": [ "Hypericum perforatum" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR1149/023/001", "product_name": "Nux vom", "holder": "A. Nelson & Company Limited", "authorised_date": "2011-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [], "active_substances": [ "Strychnos nux-vomica" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC)" }, { "licence_number": "HOR1149/025/001", "product_name": "Rhus tox", "holder": "A. Nelson & Company Limited", "authorised_date": "2010-10-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [], "active_substances": [ "Rhus toxicodendron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR1149/026/001", "product_name": "Ruta grav", "holder": "A. Nelson & Company Limited", "authorised_date": "2010-10-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pillules", "atc_codes": [], "active_substances": [ "Ruta graveolens" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR1149/029/001", "product_name": "SULFUR", "holder": "A. Nelson & Company Limited", "authorised_date": "2011-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Not assigned", "atc_codes": [], "active_substances": [ "Sulfur" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR1149/031/001", "product_name": "Arnica", "holder": "A. Nelson & Company Limited", "authorised_date": "2017-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [ "Arnica montana" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "HOR22892/002/001", "product_name": "Arnica", "holder": "Nelsons GmbH", "authorised_date": "2010-10-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pillules", "atc_codes": [], "active_substances": [ "Arnica montana" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC)" }, { "licence_number": "HOR23380/001/001", "product_name": "Arnica 30 C tablets", "holder": "Weleda AG", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [ "Arnica planta tota 30X dilution" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "", "legal_basis": "Simplified Registration for a Homeopathic Medicinal Product (Article 14, Directive 2001/83/EC)" }, { "licence_number": "PA0046/004/008", "product_name": "Fucidin 20 mg/g ointment", "holder": "Leo Laboratories Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D06AX", "D06AX01" ], "active_substances": [ "Sodium fusidate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/004/012", "product_name": "Fucidin 20 mg/g cream", "holder": "Leo Laboratories Limited", "authorised_date": "1980-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06AX", "D06AX01" ], "active_substances": [ "Fusidic acid hemihydrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/004/014", "product_name": "Fucidin 250mg Tablets", "holder": "Leo Laboratories Limited", "authorised_date": "1990-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01XC", "J01XC01" ], "active_substances": [ "Sodium fusidate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/005/005", "product_name": "Fucidin H 20mg/g + 10mg/g Cream", "holder": "Leo Laboratories Limited", "authorised_date": "1985-03-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CA", "D07CA01" ], "active_substances": [ "Fusidic acid", "HYDROCORTISONE ACETATE" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/040/001", "product_name": "Fucibet 20 mg/g + 1 mg/g cream", "holder": "Leo Laboratories Limited", "authorised_date": "1984-05-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC", "D07CC01" ], "active_substances": [ "Fusidic acid", "Betamethasone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/040/002", "product_name": "Fucibet Lipid 20mg/g + 1mg/g cream", "holder": "Leo Laboratories Limited", "authorised_date": "2006-05-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC", "D07CC01" ], "active_substances": [ "Fusidic acid", "Betamethasone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/002", "product_name": "Innohep 10,000 IU/ml solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1991-10-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/003", "product_name": "Innohep 20,000 IU/ml Solution for Injection", "holder": "Leo Laboratories Limited", "authorised_date": "1995-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/004", "product_name": "Innohep 18,000 IU in 0.9 ml, solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1997-01-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/007", "product_name": "Innohep 4,500 IU, solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1997-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/008", "product_name": "Innohep 2,500 IU, solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1997-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/009", "product_name": "Innohep 3,500 IU, solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1997-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/010", "product_name": "Innohep 10,000 IU in 0.5 ml, solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1997-01-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/011", "product_name": "Innohep 14,000 IU in 0.7 ml, solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "1997-01-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/012", "product_name": "Innohep 8,000 IU in 0.4 ml, Solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/013", "product_name": "Innohep 12,000 IU in 0.6 ml, Solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/060/014", "product_name": "Innohep 16,000 IU in 0.8 ml, Solution for injection", "holder": "Leo Laboratories Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/061/001", "product_name": "Dovonex 50 microgram/g Ointment", "holder": "Leo Laboratories Limited", "authorised_date": "1991-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D05AX", "D05AX02" ], "active_substances": [ "Calcipotriol" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0046/061/002", "product_name": "Dovonex 50 micrograms/g Cream", "holder": "Leo Laboratories Limited", "authorised_date": "1994-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D05AX", "D05AX02" ], "active_substances": [ "Calcipotriol hydrate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/014/001", "product_name": "Pethidine Hydrochloride 50mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AB", "N02AB02" ], "active_substances": [ "Pethidine hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/020/001", "product_name": "Morphine Sulphate 10mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/020/003", "product_name": "Morphine Sulphate 1mg/5ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1995-05-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/020/004", "product_name": "Morphine Sulphate 30 mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1995-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/020/008", "product_name": "Morphine Sulphate 60 mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1995-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/029/001", "product_name": "Codant 30 mg Tablets", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R05DA", "R05DA04" ], "active_substances": [ "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/035/001", "product_name": "Adrenaline (Epinephrine) 1:1,000 Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Adrenaline (epinephrine)" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/059/004", "product_name": "Furosemide 20mg in 2ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1982-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/059/005", "product_name": "Furosemide 50mg in 5ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1990-05-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/059/006", "product_name": "Furosemide 250mg in 25ml Solution for Injection/Infusion", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1990-05-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/084/001", "product_name": "Metoclopramide 5mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1984-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A03FA", "A03FA01" ], "active_substances": [ "Metoclopramide hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/091/001", "product_name": "Bupivacaine Hydrochloride 0.25% w/v Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1988-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride" ], "routes": [ "Epidural use", "Intraarticular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/091/002", "product_name": "Bupivacaine Hydrochloride 0.5% w/v Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1988-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride" ], "routes": [ "Epidural use", "Intraarticular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/099/001", "product_name": "Aminophylline Hydrate 25mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1988-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "R03DA", "R03DA05" ], "active_substances": [ "Aminophylline hydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/101/001", "product_name": "Haloperidol 5mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1988-10-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AD", "N05AD01" ], "active_substances": [ "Haloperidol" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/106/001", "product_name": "Potassium Chloride 15% w/v Concentrate for Solution for Infusion", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "A12BA", "A12BA01" ], "active_substances": [ "Potassium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/108/001", "product_name": "Sterile Dopamine Concentrate BP 40mg/ml", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1989-08-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA", "C01CA04" ], "active_substances": [ "DOPAMINE HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/108/002", "product_name": "Sterile Dopamine Concentrate BP 160mg/ml, 5ml", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1989-08-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA04" ], "active_substances": [ "DOPAMINE HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/110/001", "product_name": "Suxamethonium Chloride 50mg/ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1988-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M03AB", "M03AB01" ], "active_substances": [ "Suxamethonium chloride" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/111/002", "product_name": "Naloxone Hydrochloride 400 micrograms/ml Solution for Injection or Infusion", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1989-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AB", "V03AB15" ], "active_substances": [ "NALOXONE HYDROCHLORIDE" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/122/001", "product_name": "Fentanyl 100 micrograms in 2 ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1990-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01AH", "N01AH01" ], "active_substances": [ "FENTANYL CITRATE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/122/002", "product_name": "Fentanyl 500 micrograms in 10 ml Solution for Injection", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1990-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01AH", "N01AH01" ], "active_substances": [ "FENTANYL CITRATE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/137/001", "product_name": "Dobutamine 12.5mg/ml Concentrate for Solution for Infusion", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1996-01-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA07" ], "active_substances": [ "DOBUTAMINE HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/139/001", "product_name": "Warfant 1 mg Tablets", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1995-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "WARFARIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/139/002", "product_name": "Warfant 3 mg Tablets", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1995-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "WARFARIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0073/139/003", "product_name": "Warfant 5 mg Tablets", "holder": "Mercury Pharmaceuticals (Ireland) Ltd", "authorised_date": "1995-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "WARFARIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/002/001", "product_name": "Tropex 5% w/v Ear Drops Solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1976-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear drops, solution", "atc_codes": [ "S02DA", "S02DA03" ], "active_substances": [ "Phenazone" ], "routes": [ "Auricular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/008/001", "product_name": "Rowachol Gastro-resistant Capsules, Soft", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, soft", "atc_codes": [], "active_substances": [ "Menthol", "Menthone", "Alpha pinene", "Borneol", "Cineole", "Camphene", "Beta pinene" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/008/002", "product_name": "Rowachol Oral Drops, Solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [ "Alpha pinene", "Borneol", "Menthol", "Beta pinene", "Menthone", "Camphene", "Cineole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/009/001", "product_name": "Rowatinex Gastro-resistant Capsules, Soft", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, soft", "atc_codes": [], "active_substances": [ "Beta pinene", "Cineole", "Camphene", "Alpha pinene", "Fenchone", "Anethole", "Borneol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/009/002", "product_name": "Rowatinex Oral Drops, Solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [ "Anethol", "Alpha pinene", "Borneol", "Fenchone", "Camphene", "Cineole", "Beta pinene" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/011/001", "product_name": "Carbosan 2% w/w Gel", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "1987-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "A02BX01" ], "active_substances": [ "CARBENOXOLONE SODIUM" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/015/001", "product_name": "MEFAC 250 mg hard capsules", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1988-04-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AG", "M01AG01" ], "active_substances": [ "Mefenamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/015/002", "product_name": "MEFAC 500 mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "1988-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AG", "M01AG01" ], "active_substances": [ "Mefenamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/016/001", "product_name": "Rowatanal Cream", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "1996-05-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "C05AX", "C05AX04" ], "active_substances": [ "Bismuth subgallate", "Zinc oxide", "Menthol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/046/001", "product_name": "Rowarolan Cutaneous Powder", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "1999-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous powder", "atc_codes": [], "active_substances": [ "Calcium carbonate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/062/001", "product_name": "Magnesium Verla 5 mmol granules for oral solution", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "1997-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "A12CC05" ], "active_substances": [ "Magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/065/001", "product_name": "Rowalief 500 mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2012-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/065/002", "product_name": "Rowalief Max 1000 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2012-12-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/067/001", "product_name": "Brupro 200mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/067/002", "product_name": "Brupro Max 400mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/067/003", "product_name": "Brupro Rx 600mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/067/004", "product_name": "Brupro for Children 100 mg/5 ml oral suspension", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/067/005", "product_name": "Brupro for Children Six Plus 200 mg/5 ml oral suspension", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/067/006", "product_name": "Brupro Cold & Flu 200 mg/30 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R05X" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/069/001", "product_name": "Pantup 20 mg gastro-resistant tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/069/002", "product_name": "Pantup 40 mg gastro-resistant tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/070/001", "product_name": "Tramadol /Paracetamol Rowa 37.5 mg/325 mg Film-coated Tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2017-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ13" ], "active_substances": [ "Tramadol hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/071/001", "product_name": "Xtex 250 mg /5 ml oral solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CB", "R05CB03" ], "active_substances": [ "Carbocisteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/072/001", "product_name": "Lotanos Comp 50 mg/12.5 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2008-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/072/002", "product_name": "Lotanos Comp 100 mg/25 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2008-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/073/001", "product_name": "Razole 10 mg Gastro-resistant tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2009-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC04" ], "active_substances": [ "Rabeprazole sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/073/002", "product_name": "Razole 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"market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/076/001", "product_name": "Dutasteride/Tamsulosin Rowa 0.5 mg/0.4 mg hard capsules.", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2020-09-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA52" ], "active_substances": [ "Tamsulosin hydrochloride", "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/076/002", "product_name": "Dutasteride Rowa 0.5 mg soft capsules", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2019-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G04CB02" ], "active_substances": [ "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/078/001", "product_name": "Telmisartan Rowa 20 mg tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2020-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], 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"Irbesartan Rowa 75 mg tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/080/002", "product_name": "Irbesartan Rowa 150 mg tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/080/003", "product_name": "Irbesartan Rowa 300 mg tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/081/001", "product_name": "Telmisartan/Hydrochlorothiazide Rowa 40 mg/12.5 mg tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2014-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA07" ], "active_substances": [ "Telmisartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/081/002", "product_name": "Telmisartan/Hydrochlorothiazide Rowa 80 mg/12.5 mg tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2014-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA07" ], "active_substances": [ "Telmisartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/082/003", "product_name": "Losartan Rowa 100mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2020-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/083/001", "product_name": "Valsartan Rowa 40 mg film-coated 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(B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/083/003", "product_name": "Valsartan Rowa 160 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2011-04-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/083/004", "product_name": "Valsartan Rowa 320 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2011-04-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/084/001", "product_name": "Terbinafine Rowa 250 mg tablets", "holder": "Rowa Pharmaceuticals Limited", "authorised_date": "2007-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "D01BA", "D01BA02" ], "active_substances": [ "Terbinafine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/085/001", "product_name": "Febuxostat Rowa 80 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/085/002", "product_name": "Febuxostat Rowa 120 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/086/001", "product_name": "Fingolimod 0.5 mg hard capsules", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2020-08-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "Fingolimod" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/087/001", "product_name": "Fampridine Rowa 10 mg prolonged-release tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-07-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N07XX07" ], "active_substances": [ "Fampridine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/089/001", "product_name": "Sitagliptin Rowa 25 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/089/002", "product_name": "Sitagliptin Rowa 50 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/089/003", "product_name": "Sitagliptin Rowa 100 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/090/001", "product_name": "Sitagliptin/Metformin hydrochloride Rowa 50 mg/850 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Metformin Hydrochloride", "Sitagliptin Hydrochloride Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/090/002", "product_name": "Sitagliptin/Metformin hydrochloride Rowa 50 mg/1000 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Hydrochloride Monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/091/001", "product_name": "Fesoterodine Rowa 4 mg prolonged-release tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/091/002", "product_name": "Fesoterodine Rowa 8 mg prolonged-release tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/092/001", "product_name": "Abiraterone Rowa 500 mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2022-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/093/001", "product_name": "Rosuvastatin Rowa 5 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/093/002", "product_name": "Rosuvastatin Rowa 10 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/093/003", "product_name": "Rosuvastatin Rowa 20 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/093/004", "product_name": "Rosuvastatin Rowa 40 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/094/001", "product_name": "Tradol 50 mg Effervescent tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/095/001", "product_name": "Dabigatran etexilate Rowa 110 mg hard capsules", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/095/002", "product_name": "Dabigatran etexilate Rowa 150 mg hard capsules", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/096/001", "product_name": "Fexo Allergy Relief 120 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/097/001", "product_name": "Rivaroxaban Rowa 10 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2024-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/097/002", "product_name": "Rivaroxaban Rowa 15 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2024-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/097/003", "product_name": "Rivaroxaban Rowa 20 mg film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2024-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/098/001", "product_name": "Apixaban Rowa 2.5 mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/098/002", "product_name": "Apixaban Rowa 5 mg Film-coated tablets", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/099/001", "product_name": "Midazolam Rowa 2.5 mg oromucosal solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/099/002", "product_name": "Midazolam Rowa 5 mg oromucosal solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/099/003", "product_name": "Midazolam Rowa 7.5 mg oromucosal solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/099/004", "product_name": "Midazolam Rowa 10 mg oromucosal solution", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0074/101/001", "product_name": "Tamsulosin Rowa 400 microgram modified-release hard capsules", "holder": "Rowa Pharmaceuticals Limited,", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/008/001", "product_name": "Furosemide 20 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1978-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/008/002", "product_name": "Furosemide 40 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1978-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/011/001", "product_name": "Anxicalm 2 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1979-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA01" ], "active_substances": [ "Diazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/011/002", "product_name": "Anxicalm 5 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1979-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA01" ], "active_substances": [ "Diazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/011/003", "product_name": "Anxicalm 10 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1979-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA01" ], "active_substances": [ "Diazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/012/001", "product_name": "Melfen 200mg Film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1980-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen ph. eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/012/002", "product_name": "Melfen 400mg Film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1980-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen ph. eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/019/001", "product_name": "Phenobarbital 15 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AA", "N03AA02" ], "active_substances": [ "Phenobarbital" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/019/002", "product_name": "Phenobarbital 30 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AA", "N03AA02" ], "active_substances": [ "Phenobarbital" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/020/001", "product_name": "Paralief 500mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1981-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/020/004", "product_name": "Paralief 500 mg Effervescent Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/020/005", "product_name": "Paralief Max 1000 mg Effervescent Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/020/006", "product_name": "Paralief Hot Lemon Drink 600 mg powder for oral solution in sachet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution in sachet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/020/007", "product_name": "Paralief 500 mg soft capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/020/008", "product_name": "Paralief 500 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/026/001", "product_name": "Clonactil 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AA", "N05AA01" ], "active_substances": [ "CHLORPROMAZINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/026/002", "product_name": "Clonactil 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AA", "N05AA01" ], "active_substances": [ "CHLORPROMAZINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/026/003", "product_name": "Clonactil 25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AA", "N05AA01" ], "active_substances": [ "CHLORPROMAZINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/027/001", "product_name": "Prednisolone 5 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1982-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/027/002", "product_name": "Prednisolone 1 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1988-05-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/035/001", "product_name": "Rivaroxaban Clonmel 2.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/035/002", "product_name": "Rivaroxaban Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/035/003", "product_name": "Rivaroxaban Clonmel 15 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/035/004", "product_name": "Rivaroxaban Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/035/005", "product_name": "Rivaroxaban Clonmel 15 mg film-coated tablets Rivaroxaban Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/038/001", "product_name": "Tipuric 100 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1983-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/038/002", "product_name": "Tipuric 300 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1983-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/041/001", "product_name": "Amitriptyline 25 mg Film-Coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1985-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA", "N06AA09" ], "active_substances": [ "Amitriptyline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/057/001", "product_name": "Folic Acid 5mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1988-05-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B03BB", "B03BB01" ], "active_substances": [ "Folic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/060/001", "product_name": "Easofen 200mg Film-Coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1986-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/060/002", "product_name": "Easofen Max Strength 400 mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/060/003", "product_name": "Easofen for Children Strawberry 100mg/5ml Oral Suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2014-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/060/004", "product_name": "Easofen for Children Six Plus Strawberry 200mg/5ml Oral Suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2014-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/069/001", "product_name": "Atenomel 50 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB03" ], "active_substances": [ "Atenolol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/069/002", "product_name": "Atenomel 100 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB03" ], "active_substances": [ "Atenolol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/069/003", "product_name": "Atenomel 25 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB03" ], "active_substances": [ "Atenolol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/077/002", "product_name": "Cimeldine 400 mg Film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1989-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA", "A02BA01" ], "active_substances": [ "Cimetidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/095/001", "product_name": "Clonfolic 0.4 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1995-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B03BB", "B03BB01" ], "active_substances": [ "Folic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/104/001", "product_name": "Zopitan 3.75 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/104/002", "product_name": "Zopitan 7.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/110/001", "product_name": "Prozamel 20 mg Capsules, Hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB", "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/112/001", "product_name": "Zestan 2.5mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/112/002", "product_name": "Zestan 5mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/112/003", "product_name": "Zestan 10 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/112/004", "product_name": "Zestan 20 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/117/001", "product_name": "Nytamel 5 mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2002-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/117/002", "product_name": "Nytamel 10 mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2002-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/125/001", "product_name": "Simtan 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/125/002", "product_name": "Simtan 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/125/003", "product_name": "Simtan 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/125/004", "product_name": "Simtan 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/131/001", "product_name": "Ciprotan 10mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2004-11-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/131/002", "product_name": "Ciprotan 20mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2004-11-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/135/001", "product_name": "Serimel 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/135/002", "product_name": "Serimel 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/136/001", "product_name": "Clonocid 250 mg film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/136/002", "product_name": "Clonocid 500 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/137/001", "product_name": "Calvepen 333 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "PHENOXYMETHYLPENICILLIN CALCIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/137/002", "product_name": "Calvepen 666 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "PHENOXYMETHYLPENICILLIN CALCIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/137/003", "product_name": "Calvepen 250 mg/5 ml Powder for Oral Suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1986-01-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "PHENOXYMETHYLPENICILLIN CALCIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/140/001", "product_name": "Pravamel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2004-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/140/002", "product_name": "Pravamel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2004-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/140/003", "product_name": "Pravamel 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2004-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/141/001", "product_name": "Fungasil 250 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "D01BA", "D01BA02" ], "active_substances": [ "Terbinafine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/147/001", "product_name": "Zomel 15 mg gastro-resistant capsule, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/147/002", "product_name": "Zomel 30 mg gastro-resistant capsule, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/148/002", "product_name": "Osteomel Once Weekly 70 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/150/001", "product_name": "Azithromycin Clonmel 250 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA10" ], "active_substances": [ "Azithromycin dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/151/001", "product_name": "Tamnic 400 micrograms Modified-release Capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2006-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/152/001", "product_name": "Caldesene 10% w/w Medicated Powder", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1977-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous powder", "atc_codes": [ "D01AE", "D01AE54" ], "active_substances": [ "Calcium undecylenate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/153/001", "product_name": "Caldease 15% w/w Medicated Ointment", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1985-01-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D02AB" ], "active_substances": [ "Zinc oxide" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/154/001", "product_name": "Desenex Ointment Zinc Undecylenate 20% w/w Undecylenic Acid 5% w/w", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1998-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D01AE", "D01AE04" ], "active_substances": [ "Zinc undecylenate", "Undecylenic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/154/002", "product_name": "Desenex Powder Zinc undecylenate 20% w/w Undecylenic Acid 2.0% w/w", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1998-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous powder", "atc_codes": [ "D01AE", "D01AE04" ], "active_substances": [ "Zinc undecylenate", "Undecylenic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/163/001", "product_name": "Ramitace 2.5mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/163/002", "product_name": "Ramitace 5 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/163/003", "product_name": "Ramitace 10mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/165/001", "product_name": "Nebimel 5 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2007-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB12" ], "active_substances": [ "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/169/002", "product_name": "Perdamel 0.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2007-09-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/169/003", "product_name": "Perdamel 1 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2007-09-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/169/004", "product_name": "Perdamel 2 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2007-09-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/169/005", "product_name": "Perdamel 3 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2007-09-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/169/006", "product_name": "Perdamel 4 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2007-09-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/173/001", "product_name": "Miramel 0.088 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole dihydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/173/002", "product_name": "Miramel 0.18 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC05" ], "active_substances": [ "Pramipexole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/173/003", "product_name": "Miramel 0.7 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC", "N04BC05" ], "active_substances": [ "Pramipexole dihydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/175/001", "product_name": "Pantium 20 mg gastro-resistant tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2008-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/175/002", "product_name": "Pantium 40mg Gastro-Resistant Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2008-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium 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"Clonmel Healthcare Ltd", "authorised_date": "2009-02-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/185/001", "product_name": "Seropia 25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/185/002", "product_name": "Seropia 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/185/003", "product_name": "Seropia 200 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/185/004", "product_name": "Seropia 300 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/187/001", "product_name": "Lercanidipine Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/187/002", "product_name": "Lercanidipine Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/188/001", "product_name": "Temozolomide Clonmel 5mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/188/002", "product_name": "Temozolomide Clonmel 20 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/188/003", "product_name": "Temozolomide Clonmel 100mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/188/004", "product_name": "Temozolomide Clonmel 140mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/188/005", "product_name": "Temozolomide Clonmel 180 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/188/006", "product_name": "Temozolomide Clonmel 250 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/189/001", "product_name": "Amidex 1 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/197/001", "product_name": "Risontel Once a week 35mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA07" ], "active_substances": [ "Risedronate sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/198/001", "product_name": "Letrozole 2.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/199/001", "product_name": "Sildenafil Clonmel 25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/199/002", "product_name": "Sildenafil Clonmel 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/199/003", "product_name": "Sildenafil Clonmel 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/199/004", "product_name": "Sildenafil Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/201/001", "product_name": "Viralief 50 mg/g Cream", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1998-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB03" ], "active_substances": [ "Aciclovir" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/202/001", "product_name": "Doxatan 1mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2000-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/202/002", "product_name": "Doxatan 2mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2000-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/202/003", "product_name": "Doxatan 4mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2000-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/202/004", "product_name": "Doxatan XL 4 mg Prolonged-release Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/203/001", "product_name": "Profloxin 250 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/203/002", "product_name": "Profloxin 500 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2005-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/205/001", "product_name": "Irbesartan Clonmel 75 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/205/002", "product_name": "Irbesartan Clonmel 150 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/205/003", "product_name": "Irbesartan Clonmel 300 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA04" ], "active_substances": [ "Irbesartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/206/001", "product_name": "Candist 4 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/206/002", "product_name": "Candist 8 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/206/003", "product_name": "Candist 16 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/207/002", "product_name": "Candist Plus 16 mg/12.5 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-10-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/208/001", "product_name": "Esomeprazole Clonmel 20 mg gastro-resistant capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/208/002", "product_name": "Esomeprazole Clonmel 40 mg gastro-resistant capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/210/001", "product_name": "Olanzapine 2.5mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/210/002", "product_name": "Olanzapine 5mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/210/003", "product_name": "Olanzapine 7.5mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/210/004", "product_name": "Olanzapine 10mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/210/005", "product_name": "Olanzapine 15mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/210/006", "product_name": "Olanzapine 20mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/211/001", "product_name": "Valtan 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/212/001", "product_name": "Etalopro 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/212/002", "product_name": "Etalopro 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/212/003", "product_name": "Etalopro 15 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/212/004", "product_name": "Etalopro 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/215/001", "product_name": "Montelair 4 mg Chewable Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/215/002", "product_name": "Montelair 5 mg Chewable Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2010-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/215/003", "product_name": "Montelair 10 mg Film-coated 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"market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/228/001", "product_name": "Telmisartan Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/228/002", "product_name": "Telmisartan Clonmel 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/228/003", "product_name": "Telmisartan Clonmel 80 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/231/001", "product_name": "Toltertan SR 2 mg Prolonged-Release Capsules, Hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2012-11-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/231/002", "product_name": "Toltertan SR 4 mg Prolonged-Release Capsules, Hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2012-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/235/001", "product_name": "Denzapine ®25 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2008-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Not Currently Available", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/235/002", "product_name": "Denzapine ®100 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2008-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Not Currently Available", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/235/003", "product_name": "Denzapine ®50 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/235/004", "product_name": "Denzapine ®200 mg Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/235/005", "product_name": "Denzapine ®50 mg/ml Oral Suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/236/001", "product_name": "Trimega 1000 mg Capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2012-08-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "C10AX", "C10AX06" ], "active_substances": [ "Omega-3-acid ethyl esters 90" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/238/001", "product_name": "Linezolid Clonmel 600 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/240/001", "product_name": "Ibandronic Acid Clonmel 150 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/243/001", "product_name": "Clavamel Forte 500mg/125mg film-coated tablet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2014-03-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/244/001", "product_name": "Xymel Comp 37.5mg/325mg Film-Coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ13" ], "active_substances": [ "Tramadol hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/247/001", "product_name": "Caldesene Adult 10% w/w Medicated Powder", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2014-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous 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"PA0126/255/002", "product_name": "Memantine Clonmel 10mg Film-coated Tablet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-09-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX", "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/258/001", "product_name": "Amlodipine Clonmel 5 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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(Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/260/003", "product_name": "Olmesartan/Hydrochlorothiazide Clonmel 40 mg/12.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/260/004", "product_name": "Olmesartan/Hydrochlorothiazide Clonmel 40 mg/25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", 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}, { "licence_number": "PA0126/261/002", "product_name": "Rosuvastatin Clonmel 10mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/261/003", "product_name": "Rosuvastatin Clonmel 20mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/266/002", "product_name": "Aripiprazole Clonmel 10 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02", "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/266/003", "product_name": "Aripiprazole Clonmel 15 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/266/004", "product_name": "Aripiprazole Clonmel 30 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02", "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/267/001", "product_name": "Anti-Hist Allergy 10mg Film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2006-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/267/002", "product_name": "Anti-Hist Allergy 1 mg/ml oral solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-05-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetrizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/269/002", "product_name": "Duloxetine Clonmel 30 mg gastro resistant capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06A" ], "active_substances": [ "Duloxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/271/004", "product_name": "Atorvastatin Clonmel 80 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/272/001", "product_name": "Paralief Cold & Flu hard capsules Paracetamol 300 mg Caffeine 25 mg 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"Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/273/002", "product_name": "Olmesartan Medoxomil Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/273/003", "product_name": "Olmesartan Medoxomil Clonmel 40 mg film-coated tablet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/274/001", "product_name": "Amlodipine/Valsartan Clonmel 5 mg/80 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB01" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB01" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/275/001", "product_name": "Seropia XR 50 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/275/002", "product_name": "Seropia XR 150 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/275/003", "product_name": "Seropia XR 200 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/275/004", "product_name": "Seropia XR 300 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/275/005", "product_name": "Seropia XR 400 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/276/001", "product_name": "Rasagiline Clonmel 1 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Rasagiline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/279/001", "product_name": "Clopidogrel Clonmel 75mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC04" ], "active_substances": [ "Clopidogrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/280/001", "product_name": "Binosto Once Weekly 70 mg effervescent tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2012-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/281/001", "product_name": "Ezetimibe/Simvastatin Clonmel 10 mg/10 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-04-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/281/002", "product_name": "Ezetimibe/Simvastatin 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may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/281/004", "product_name": "Ezetimibe/Simvastatin Clonmel 10 mg/80 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-04-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/282/001", "product_name": "Amoxicillin 250 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", 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"licence_number": "PA0126/282/003", "product_name": "Amoxicillin 125 mg/5 ml powder for oral suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/282/004", "product_name": "Amoxicillin 250 mg/5 ml powder for oral suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/285/001", "product_name": "Venex XL 37.5 mg Prolonged-release Capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/285/002", "product_name": "Venex XL 75 mg 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/288/001", "product_name": "Solifenacin Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/288/002", "product_name": "Solifenacin Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/289/001", "product_name": "Emtricitabine/Tenofovir disoproxil Clonmel 200 mg/245 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Emtricitabine", "Tenofovir disoproxil succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/001", "product_name": "Pregabalin Clonmel 25 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/002", "product_name": "Pregabalin Clonmel 50 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/003", "product_name": "Pregabalin Clonmel 75 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/004", "product_name": "Pregabalin Clonmel 100 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/005", "product_name": "Pregabalin Clonmel 150 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/006", "product_name": "Pregabalin Clonmel 200 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/290/008", "product_name": "Pregabalin Clonmel 300 mg capsules, hard", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/291/001", "product_name": "Ridonex 10 mg orodispersible tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/293/001", "product_name": "Olmesartan/Amlodipine Clonmel 20 mg/5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/293/002", "product_name": "Olmesartan/Amlodipine Clonmel 40 mg/5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/293/003", "product_name": "Olmesartan/Amlodipine Clonmel 40 mg/10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/294/001", "product_name": "Easolief Duo 500mg/150mg Film-coated Tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/295/001", "product_name": "Febuxostat Clonmel 80 mg Film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-04-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/295/002", "product_name": "Febuxostat Clonmel 120 mg Film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-04-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/297/001", "product_name": "Bortezomib Clonmel 2.5 mg/ml Solution for Injection", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2018-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX", "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/299/002", "product_name": "Darunavir Clonmel 600 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"Unknown", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "R02AA", "R02AA05" ], "active_substances": [ "Lidocaine hydrochloride", "Chlorhexidine digluconate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/303/001", "product_name": "Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 5 mg/160 mg/12.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX01" ], "active_substances": [ "Amlodipine besilate", "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be 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"holder": "Clonmel Healthcare Ltd", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX01" ], "active_substances": [ "Amlodipine besilate", "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/303/004", "product_name": "Amlodipine/Valsartan/Hydrochlorothiazide Clonmel 10 mg/160 mg/25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX01" ], "active_substances": [ "Amlodipine besilate", "Valsartan", 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"PA0126/305/001", "product_name": "Loperamide Clonmel 2 mg orodispersible tablet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2019-09-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/306/001", "product_name": "Cinacalcet Clonmel 30 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2019-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05BX01" ], "active_substances": [ "Cinacalcet hydrochloride" ], "routes": [ "Oral use" ], 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"2019-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05BX01" ], "active_substances": [ "Cinacalcet hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/307/001", "product_name": "Posaconazole Clonmel 100 mg gastro-resistant tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "J02AC", "J02AC04" ], "active_substances": [ "Posaconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/309/001", "product_name": "Nicospray 1 mg/spray oromucosal spray, solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2019-11-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/310/001", "product_name": "Dasatinib Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA02" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/310/002", "product_name": "Dasatinib Clonmel 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA02" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/310/003", "product_name": "Dasatinib Clonmel 70 mg film-coated 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"Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/311/001", "product_name": "Tadalafil Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/311/002", "product_name": "Tadalafil Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated 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Directive No 2001/83/EC)" }, { "licence_number": "PA0126/312/002", "product_name": "Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/5 mg/12.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/312/003", "product_name": "Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/10 mg/12.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/312/004", "product_name": "Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/5 mg/25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/312/005", "product_name": "Olmesartan medoxomil/Amlodipine/Hydrochlorothiazide Clonmel 40 mg/10 mg/25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/313/001", "product_name": "Crystapen 600 mg Powder for Solution for Injection or Infusion", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2001-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE", "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/314/001", "product_name": "Galfer 305 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1976-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B03AA", "B03AA02" ], "active_substances": [ "Ferrous fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/314/002", "product_name": "Galfer 140 mg/5ml Oral Suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "B03AA", "B03AA02" ], "active_substances": [ "Ferrous fumarate Ph.Eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/315/001", "product_name": "Nizoral Dandruff 20mg/g Shampoo", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1999-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D01AC", "D01AC08" ], "active_substances": [ "Ketoconazole" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/315/002", "product_name": "Nizoral 20mg/g shampoo", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1990-04-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D01AC", "D01AC08" ], "active_substances": [ "Ketoconazole" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/315/003", "product_name": "Nizoral 20 mg/g Cream", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1987-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC08" ], "active_substances": [ "Ketoconazole" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/317/001", "product_name": "Galfer FA 305 mg/0.35 mg Hard Capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1976-06-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B03AD", "B03AD02" ], "active_substances": [ "Ferrous fumarate", "Folic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/318/001", "product_name": "Crampex TabletsCholecalciferol 0.02 mgCalcium Gluconate 200 mgNicotinic Acid 20 mg", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1993-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Cholecalciferol", "Calcium gluconate", "Nicotinic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/319/001", "product_name": "Fingolimod Clonmel 0.5 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "Fingolimod" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/001", "product_name": "Lenalidomide Clonmel 2.5 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/002", "product_name": "Lenalidomide Clonmel 5 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/003", "product_name": "Lenalidomide Clonmel 7.5 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/004", "product_name": "Lenalidomide Clonmel 10 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/005", "product_name": "Lenalidomide Clonmel 15 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/006", "product_name": "Lenalidomide Clonmel 20 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/320/007", "product_name": "Lenalidomide Clonmel 25 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/321/001", "product_name": "Oilatum Cream", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2003-03-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AC" ], "active_substances": [ "Liquid paraffin light", "White soft paraffin" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/322/001", "product_name": "Oilatum Emollient 63.4% w/w Bath Additive", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1984-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Bath additive", "atc_codes": [ "D02AC" ], "active_substances": [ "Liquid paraffin light" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/323/001", "product_name": "Oilatum Junior Flare-Up Bath Additive Light liquid paraffin 52.5% w/w Benzalkonium chloride 6.0% w/w Triclosan", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1989-05-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Bath additive", "atc_codes": [ "D02AC" ], "active_substances": [ "Light liquid paraffin", "Benzalkonium chloride", "Triclosan" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/324/002", "product_name": "Savlon Antiseptic Cream Cetrimide 0.5% w/w Chlorhexidine Digluconate 0.1% w/w", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1991-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D08AJ", "D08AJ04" ], "active_substances": [ "Cetrimide", "Chlorhexidine gluconate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/325/001", "product_name": "Eurax 10% w/w Cream", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D04AX" ], "active_substances": [ "Crotamiton" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/326/001", "product_name": "Levetiracetam Clonmel 250 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/326/002", "product_name": "Levetiracetam Clonmel 500 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/326/003", "product_name": "Levetiracetam Clonmel 1000 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/327/001", "product_name": "Sitagliptin/Metformin Clonmel 50 mg/850 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Metformin Hydrochloride", "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/327/002", "product_name": "Sitagliptin/Metformin Clonmel 50 mg/1000 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/328/001", "product_name": "Apixaban Clonmel 2.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/328/002", "product_name": "Apixaban Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/330/001", "product_name": "Tefin 75 mg Suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2012-08-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/330/002", "product_name": "Tefin 150 mg Suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2012-08-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/331/001", "product_name": "Tipol 75 mg suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/331/002", "product_name": "Tipol 125 mg suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/331/003", "product_name": "Tipol 250 mg suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/331/004", "product_name": "Tipol 500 mg suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/331/005", "product_name": "Tipol Max 1000 mg suppositories", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/332/001", "product_name": "Co-Tipol 500 mg/30 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2013-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/334/001", "product_name": "Linagliptin Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH05" ], "active_substances": [ "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/335/001", "product_name": "Fesoterodine Clonmel 4 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/335/002", "product_name": "Fesoterodine Clonmel 8 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/336/001", "product_name": "Abiraterone Clonmel 500 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/340/001", "product_name": "Dabigatran etexilate Clonmel 75 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-11-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/340/002", "product_name": "Dabigatran etexilate Clonmel 110 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-11-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/340/003", "product_name": "Dabigatran etexilate Clonmel 150 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-11-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/341/001", "product_name": "Caspofungin Clonmel 50 mg powder for concentrate for solution for infusion", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX04" ], "active_substances": [ "Caspofungin acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/341/002", "product_name": "Caspofungin Clonmel 70 mg powder for concentrate for solution for infusion", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX04" ], "active_substances": [ "Caspofungin acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/342/001", "product_name": "Sametec Airmaster 50 microgram/ 100 microgram/ dose, inhalation powder, pre-dispensed", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/342/002", "product_name": "Sametec Airmaster 50 microgram/ 250 microgram/ dose, inhalation powder, pre-dispensed", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/342/003", "product_name": "Sametec Airmaster 50 microgram/ 500 microgram/ dose, inhalation powder, pre-dispensed", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/343/001", "product_name": "Easofen Rapid Relief Max Strength 400 mg soft capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/344/001", "product_name": "Famotidine Clonmel 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/344/002", "product_name": "Famotidine Clonmel 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/350/001", "product_name": "Pirfenidone Clonmel 267 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-07-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/350/002", "product_name": "Pirfenidone Clonmel 801 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-07-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/351/001", "product_name": "Solifenacin succinate/Tamsulosin hydrochloride Clonmel 6 mg/0.4 mg modified-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-07-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "G04CA53" ], "active_substances": [ "Solifenacin succinate", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/352/001", "product_name": "Sugammadex Clonmel 100 mg/ml solution for injection", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/354/001", "product_name": "Losartan/Hydrochlorothiazide Clonmel 50 mg/12.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/354/002", "product_name": "Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/355/001", "product_name": "Losartan Clonmel 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/355/002", "product_name": "Losartan Clonmel 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/356/001", "product_name": "Ranolazine Clonmel 375 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/356/002", "product_name": "Ranolazine Clonmel 500 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/356/003", "product_name": "Ranolazine Clonmel 750 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/357/001", "product_name": "Brolene 0.1% w/v Eye Drops Solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AX", "S01AX15" ], "active_substances": [ "Propamidine isetionate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/357/002", "product_name": "Brolene 0.15 % w/w Eye Ointment", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye ointment", "atc_codes": [ "S01AX", "S01AX14" ], "active_substances": [ "Dibrompropamidine isetionate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/358/001", "product_name": "Nasorinit 137 micrograms/50 micrograms per actuation nasal spray, suspension", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD58" ], "active_substances": [ "Azelastine hydrochloride", "Fluticasone propionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/360/001", "product_name": "Tiotropium Clonmel 18 microgram inhalation powder, hard capsule", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03BB04" ], "active_substances": [ "Tiotropium bromide monohydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/362/001", "product_name": "Azacitidine 25 mg/ml powder for suspension for injection", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/363/001", "product_name": "Piperacillin/Tazobactam Clonmel 4 g/0.5 g powder for solution for infusion", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2022-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR05" ], "active_substances": [ "Tazobactam", "Piperacillin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/366/001", "product_name": "Perindopril Arginine Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-03-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/366/002", "product_name": "Perindopril Arginine Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/366/003", "product_name": "Perindopril Arginine Clonmel 2.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-03-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/368/001", "product_name": "Levetiracetam Clonmel 100 mg/ml oral solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-05-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/369/001", "product_name": "Bosutinib Clonmel 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA04" ], "active_substances": [ "Bosutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/369/002", "product_name": "Bosutinib Clonmel 400 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA04" ], "active_substances": [ "Bosutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/369/003", "product_name": "Bosutinib Clonmel 500 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA04" ], "active_substances": [ "Bosutinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/370/001", "product_name": "Paliperidone Clonmel 50 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/370/002", "product_name": "Paliperidone Clonmel 75 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/370/003", "product_name": "Paliperidone Clonmel 100 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/370/004", "product_name": "Paliperidone Clonmel 150 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/372/001", "product_name": "Diclomel Max Strength 2% w/w gel", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-04-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac Diethylamine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/373/002", "product_name": "Viaredin 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/374/001", "product_name": "Apremilast Clonmel 30 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-10-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/374/002", "product_name": "Apremilast Clonmel 10 mg film-coated tablets Apremilast Clonmel 20 mg film-coated tablets Apremilast Clonmel 30 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-10-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/375/001", "product_name": "Teriflunomide Clonmel 14 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA31" ], "active_substances": [ "Teriflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/376/002", "product_name": "Viaredin 50 mg Chewable tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/377/001", "product_name": "Eltrombopag Clonmel 25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/377/002", "product_name": "Eltrombopag Clonmel 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/377/003", "product_name": "Eltrombopag Clonmel 75 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/378/001", "product_name": "Pomalidomide Clonmel 1 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/378/002", "product_name": "Pomalidomide Clonmel 2 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/378/003", "product_name": "Pomalidomide Clonmel 3 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/378/004", "product_name": "Pomalidomide Clonmel 4 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/380/001", "product_name": "Tadalafil Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/381/001", "product_name": "Opticrom 2 % w/v Eye Drops, solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1975-12-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX01" ], "active_substances": [ "Sodium cromoglicate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0126/381/002", "product_name": "Opticrom allergy 2% w/v eye drops, solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2011-05-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX01" ], "active_substances": [ "Sodium cromoglicate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/381/003", "product_name": "Opticrom Allergy Single Dose 2% w/v eye drops, solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2015-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX01" ], "active_substances": [ "Sodium cromoglicate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/383/001", "product_name": "Nintedanib Clonmel 100 mg soft capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/383/002", "product_name": "Nintedanib Clonmel 150 mg soft capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/384/001", "product_name": "Sacubitril/Valsartan Clonmel 24 mg/26 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/384/002", "product_name": "Sacubitril/Valsartan Clonmel 49 mg/51 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/384/003", "product_name": "Sacubitril/Valsartan Clonmel 97 mg/103 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/385/001", "product_name": "Vortioxetine Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/385/002", "product_name": "Vortioxetine Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral 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"authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/386/001", "product_name": "Dabigatran Etexilate 75 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/386/002", "product_name": "Dabigatran Etexilate 110 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/386/003", "product_name": "Dabigatran Etexilate 150 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/387/001", "product_name": "Macitentan Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-08-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/389/001", "product_name": "Enzalutamide Clonmel 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/389/002", "product_name": "Enzalutamide Clonmel 80 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/390/001", "product_name": "Dapagliflozin Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin propanediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/390/002", "product_name": "Dapagliflozin Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin propanediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/391/001", "product_name": "Dimethyl fumarate Clonmel Healthcare 120 mg gastro-resistant hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-06-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/391/002", "product_name": "Dimethyl fumarate Clonmel Healthcare 240 mg gastro-resistant hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-06-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/392/001", "product_name": "Famotidine Clonmel Healthcare 20 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/392/002", "product_name": "Famotidine Clonmel Healthcare 40 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/393/001", "product_name": "Nilotinib Clonmel 50 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EA03" ], "active_substances": [ "Nilotinib hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/393/002", "product_name": "Nilotinib Clonmel 150 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EA03" ], "active_substances": [ "Nilotinib hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/393/003", "product_name": "Nilotinib Clonmel 200 mg hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EA03" ], "active_substances": [ "Nilotinib hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/001", "product_name": "Selexipag Clonmel 200 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/002", "product_name": "Selexipag Clonmel 400 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/003", "product_name": "Selexipag Clonmel 600 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/004", "product_name": "Selexipag Clonmel 800 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/005", "product_name": "Selexipag Clonmel 1000 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/006", "product_name": "Selexipag Clonmel 1200 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/007", "product_name": "Selexipag Clonmel 1400 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/394/008", "product_name": "Selexipag Clonmel 1600 microgram film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/395/001", "product_name": "Tamnic 400 microgram hard modified-release capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-10-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/396/001", "product_name": "Mirabegron Clonmel 50 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD12" ], "active_substances": [ "Mirabegron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/397/001", "product_name": "Mirabegron Clonmel 25 mg prolonged-release tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-05-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD12" ], "active_substances": [ "Mirabegron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/398/001", "product_name": "Nintedanib Clonmel Healthcare 100 mg soft capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/398/002", "product_name": "Nintedanib Clonmel Healthcare 150 mg soft capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/399/001", "product_name": "Candesartan Clonmel 4 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/399/002", "product_name": "Candesartan Clonmel 8 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/399/003", "product_name": "Candesartan Clonmel 16 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/400/001", "product_name": "Bisoprolol Clonmel 1.25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/400/002", "product_name": "Bisoprolol Clonmel 2.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/400/003", "product_name": "Bisoprolol Clonmel 3.75 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/400/004", "product_name": "Bisoprolol Clonmel 5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/400/005", "product_name": "Bisoprolol Clonmel 7.5 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/400/006", "product_name": "Bisoprolol Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/402/001", "product_name": "Ibuprofen Boots 200 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/402/002", "product_name": "Ibuprofen Boots 400 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/403/001", "product_name": "Brivaracetam Clonmel 10 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/403/002", "product_name": "Brivaracetam Clonmel 25 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/403/003", "product_name": "Brivaracetam Clonmel 50 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/403/004", "product_name": "Brivaracetam Clonmel 75 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/403/005", "product_name": "Brivaracetam Clonmel 100 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX23" ], "active_substances": [ "Brivaracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/404/001", "product_name": "Esomeprazole Clonmel 20 mg gastro-resistant tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/405/001", "product_name": "Medisils Intensive 8.75 mg lozenges", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/407/001", "product_name": "Easolief DUO Hot Drink 500 mg/150 mg powder for oral solution in sachet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen lysinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/407/002", "product_name": "Easolief DUO Hot Drink Max Strength 1000 mg/300 mg powder for oral solution in sachet", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen lysinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/411/001", "product_name": "Enzalutamide Clonmel 160 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-10-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "QL02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/412/001", "product_name": "Allopurinol Clonmel 100 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/412/002", "product_name": "Allopurinol Clonmel 200 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/412/003", "product_name": "Allopurinol Clonmel 300 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/415/001", "product_name": "Ibuprofen Rx Clonmel 200 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/415/002", "product_name": "Ibuprofen Rx Clonmel 400 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/416/001", "product_name": "Diclomel 140 mg medicated plaster", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/417/001", "product_name": "Ibuprofen Clonmel 200 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/417/002", "product_name": "Ibuprofen Clonmel Max Strength 400 mg film-coated tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/418/001", "product_name": "Ipratropium bromide Clonmel 21 micrograms per metered dose, nasal spray solution", "holder": "Clonmel Healthcare Ltd", "authorised_date": "1997-03-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AX", "R01AX03" ], "active_substances": [ "Ipratropium bromide" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/421/001", "product_name": "Furosemide Clonmel 20 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-05-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/421/002", "product_name": "Furosemide Clonmel 40 mg tablets", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-05-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0126/423/001", "product_name": "Indacaterol/Glycopyrronium Clonmel 85 microgram/43 microgram inhalation powder, hard capsules", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2026-08-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AL04" ], "active_substances": [ "Indacaterol maleate", "Glycopyrronium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0179/002/031", "product_name": "Sodium Chloride Intravenous Infusion BP 0.9% w/v Solution for Infusion, Ecobag", "holder": "B. Braun Medical Limited", "authorised_date": "2007-03-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0179/004/008", "product_name": "Compound Sodium Lactate Intravenous Infusion BP, Ecobag (Hartmann’s Solution)", "holder": "B. Braun Medical Limited", "authorised_date": "2007-03-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Sodium lactate solution", "Calcium chloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0196/013/001", "product_name": "Lignospan Special (20 mg/12.5 microgram per ml) Solution for Injection 1.8 ml", "holder": "Septodont", "authorised_date": "1988-02-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Adrenaline (epinephrine)", "Lidocaine hydrochloride" ], "routes": [ "Infiltration", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0196/013/002", "product_name": "Lignospan Special (20 mg/12.5 microgram per ml) Solution for Injection 2.2 ml", "holder": "Septodont", "authorised_date": "1988-02-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Lidocaine hydrochloride", "Adrenaline (epinephrine)" ], "routes": [ "Infiltration", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0196/014/002", "product_name": "Xylonor, 50 mg/g + 1.5 mg/g, gingival gel", "holder": "Septodont", "authorised_date": "1999-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gingival gel", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Lidocaine", "Cetrimide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0196/015/001", "product_name": "Scandonest 3% w/v Solution for Injection", "holder": "Septodont", "authorised_date": "1999-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB03" ], "active_substances": [ "Mepivacaine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0196/017/002", "product_name": "Septanest 40 mg/ml + 10 micrograms/ml, solution for injection", "holder": "Septodont", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB58" ], "active_substances": [ "Articaine hydrochloride", "Adrenaline tartrate" ], "routes": [ "Dental use", "Infiltration", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/014/001", "product_name": "Lassar’s PasteZinc Oxide 24% w/w & Salicylic Acid 2% w/w", "holder": "Ovelle Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous paste", "atc_codes": [ "D02AF" ], "active_substances": [ "Zinc oxide", "Salicylic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/014/002", "product_name": "Lassar’s Cream.Zinc Oxide 23% w/w & Salicylic Acid 2% w/w", "holder": "Ovelle Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AF" ], "active_substances": [ "Zinc oxide", "Salicylic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/016/002", "product_name": "Calamine Lotion, cutaneous suspension", "holder": "Ovelle Limited", "authorised_date": "1992-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous suspension", "atc_codes": [ "D02AB" ], "active_substances": [ "Zinc oxide", "Calamine" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/019/001", "product_name": "Emulsifying Ointment", "holder": "Ovelle Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D02AX" ], "active_substances": [ "Liquid paraffin", "White soft paraffin", "Emulsifying wax" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/020/001", "product_name": "Silcock’s Base Cream White Soft Paraffin 20%w/w, Emulsifying Wax 15% w/w", "holder": "Ovelle Limited", "authorised_date": "1989-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AC" ], "active_substances": [ "Emulsifying wax", "White soft paraffin" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/021/001", "product_name": "Aqueous Cream Emulsifying Wax 9% w/w, White Soft Parafin 15% w/w, Liquid Paraffin 6% w/w", "holder": "Ovelle Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AX" ], "active_substances": [ "Emulsifying wax", "White soft paraffin", "Liquid paraffin" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/022/001", "product_name": "Menthol & Wintergreen Cream", "holder": "Ovelle Limited", "authorised_date": "1988-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "M02AC" ], "active_substances": [ "Turpentine oil", "Oleoresin capsicum", "Methyl salicylate", "Levomenthol" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/023/001", "product_name": "Benzyl Benzoate 25% w/v Application Cutaneous Emulsion", "holder": "Ovelle Limited", "authorised_date": "1988-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous emulsion", "atc_codes": [ "P03AX", "P03AX01" ], "active_substances": [ "Benzyl benzoate" ], "routes": [ "Cutaneous use", "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/024/001", "product_name": "Whitfield's Antifungal 3% w/w & 6% w/w Ointment", "holder": "Ovelle Limited", "authorised_date": "1991-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D01AE", "D01AE12" ], "active_substances": [ "Salicylic acid", "Benzoic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/025/001", "product_name": "Iodine Tincture (Alcoholic Iodine Solution BP), Cutaneous Solution Iodine 2.5% w/v Potassium Iodide 2.5% w/v", "holder": "Ovelle Limited", "authorised_date": "1992-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AG", "D08AG03" ], "active_substances": [ "Potassium iodide", "Iodine" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/026/001", "product_name": "Iodine Liniment Strong, Cutaneous Solution Iodine 10% w/v Potassium Iodide 6% w/v", "holder": "Ovelle Limited", "authorised_date": "1992-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AG", "D08AG03" ], "active_substances": [ "Potassium iodide", "Iodine" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/027/001", "product_name": "Zinc & Castor Oil Ointment Zinc Oxide 7.5%w/w Castor Oil 50%w/w", "holder": "Ovelle Limited", "authorised_date": "1992-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D02AB" ], "active_substances": [ "Zinc oxide", "Castor oil" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/028/001", "product_name": "Zinc 15% w/w Ointment", "holder": "Ovelle Limited", "authorised_date": "1994-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D02AB" ], "active_substances": [ "Zinc oxide" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0206/030/001", "product_name": "Hydrocortisone 1% w/w Cream", "holder": "Ovelle Limited", "authorised_date": "1998-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AA", "D07AA02" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/001/001", "product_name": "Medical Nitrous Oxide", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, liquefied", "atc_codes": [ "N01AX", "N01AX13" ], "active_substances": [ "Nitrous oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/002/001", "product_name": "Medical Liquid Oxygen", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, cryogenic", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/003/001", "product_name": "Medical Oxygen", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/004/001", "product_name": "Medical Oxygen/Carbon Dioxide mixtures", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1985-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "V03AN", "V03AN01", "V03AN02" ], "active_substances": [ "Oxygen", "Carbon dioxide" ], "routes": [ "Extracorporeal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/005/001", "product_name": "Entonox", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "N01AX", "N01AX13" ], "active_substances": [ "Oxygen", "Nitrous oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/006/001", "product_name": "Medical Carbon Dioxide", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, liquefied", "atc_codes": [ "V03AN", "V03AN02" ], "active_substances": [ "Carbon dioxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0208/009/001", "product_name": "Medical Air", "holder": "BOC Gases Ireland Ltd", "authorised_date": "1985-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/008/001", "product_name": "Trisequens film-coated tablets", "holder": "Novo Nordisk A/S", "authorised_date": "1977-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FB", "G03FB05" ], "active_substances": [ "Estradiol", "Estradiol", "Norethisterone acetate", "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/022/001", "product_name": "Kliogest 2 mg/1 mg film-coated tablets", "holder": "Novo Nordisk A/S", "authorised_date": "1987-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA01" ], "active_substances": [ "Estradiol", "Norethisterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/030/002", "product_name": "Vagifem 10 micrograms vaginal tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2010-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal tablet", "atc_codes": [ "G03CA", "G03CA04" ], "active_substances": [ "Estradiol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/031/002", "product_name": "GlucaGen HypoKit 1 mg powder and solvent for solution for injection", "holder": "Novo Nordisk A/S", "authorised_date": "1991-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H04AA", "H04AA01" ], "active_substances": [ "GLUCAGON" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/040/011", "product_name": "Norditropin FlexPro 5 mg/1.5 ml, solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2011-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/040/012", "product_name": "Norditropin FlexPro 10 mg/1.5 ml, solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2011-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/040/013", "product_name": "Norditropin FlexPro 15 mg/1.5 ml, solution for injection in pre-filled pen", "holder": "Novo Nordisk A/S", "authorised_date": "2011-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/050/001", "product_name": "Estrofem 2 mg film-coated tablets", "holder": "Novo Nordisk A/S", "authorised_date": "1996-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/052/001", "product_name": "Activelle 1 mg/0.5 mg film-coated tablets", "holder": "Novo Nordisk A/S", "authorised_date": "1998-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA01" ], "active_substances": [ "Estradiol", "Norethisterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0218/053/001", "product_name": "Novofem film-coated tablets", "holder": "Novo Nordisk A/S", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA01" ], "active_substances": [ "Estradiol", "Norethisterone acetate", "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/002/001", "product_name": "Junior Parapaed Paracetamol Oral Suspension 120 mg/5 ml", "holder": "Pinewood Laboratories Limited", "authorised_date": "1982-12-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0281/002/003", "product_name": "Six Plus Parapaed Paracetamol Oral Suspension 250 mg/5 ml", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1994-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0281/005/001", "product_name": "Codinex Codeine Phosphate 15mg/5ml Oral Solution", "holder": "Pinewood Laboratories Limited", "authorised_date": "1981-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05DA", "R05DA04" ], "active_substances": [ "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/026/007", "product_name": "Primacine 125 mg/5 ml Granules for Oral Suspension", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1998-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin ethylsuccinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/026/008", "product_name": "Primacine 250 mg/5 ml Granules for Oral Suspension", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1998-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin ethylsuccinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/026/009", "product_name": "Primacine 500 mg/5 ml Granules for Oral Suspension", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1998-11-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin ethylsuccinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/031/004", "product_name": "Flucillin – Flucloxacillin Capsules 250 mg", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1995-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/031/005", "product_name": "Flucillin – Flucloxacillin capsules 500 mg", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1995-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/061/001", "product_name": "Pinadone 1 mg/ml Oral Solution", "holder": "Pinewood Laboratories Limited", "authorised_date": "1995-11-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07BC", "N07BC02" ], "active_substances": [ "Methadone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0281/063/001", "product_name": "Calcium Acetate 500mg Tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1998-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A12AA", "A12AA12" ], "active_substances": [ "Calcium acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/070/001", "product_name": "Viscolex Syrup 250 mg/5 ml Oral Solution", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1986-10-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CB", "R05CB03" ], "active_substances": [ "Carbocysteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/071/002", "product_name": "Cortopin 1% w/w Cream", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1989-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AA", "D07AA02" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/074/001", "product_name": "Paratabs 500 mg Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "1982-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/075/001", "product_name": "Acidex Oral Suspension, Sodium Alginate 500mg, Sodium Bicarbonate 267mg, Calcium Carbonate 160mg/10ml", "holder": "Pinewood Laboratories Limited", "authorised_date": "1998-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "B05CB", "B05CB04" ], "active_substances": [ "Sodium alginate", "Sodium bicarbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/079/001", "product_name": "Laxose (Lactulose Solution BP) 3.35g/5ml Oral Solution", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1996-05-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD", "A06AD11" ], "active_substances": [ "Lactulose" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/088/004", "product_name": "Fenopine 100mg/5ml Oral Suspension", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2010-09-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/088/005", "product_name": "Fenopine 200 mg/5 ml Oral Suspension", "holder": "Pinewood Laboratories Limited", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen ph. eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/088/006", "product_name": "Fenopine for Children Six Plus Strawberry 200mg/5ml Oral Suspension", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/124/001", "product_name": "Chlorpromazine Elixir BP 25 mg/5 ml Oral Solution", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1983-06-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AA", "N05AA01" ], "active_substances": [ "CHLORPROMAZINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/125/001", "product_name": "Ketoconazole 20mg/g Shampoo", "holder": "Pinewood Laboratories Limited", "authorised_date": "2006-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D01AC", "D01AC08" ], "active_substances": [ "Ketoconazole" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/127/001", "product_name": "Ondran 4 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2005-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/127/002", "product_name": "Ondran 8 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2005-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/132/001", "product_name": "Minosil 100mg Modified-release Capsules", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2007-06-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "J01AA", "J01AA08" ], "active_substances": [ "Minocycline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/151/001", "product_name": "Lansoprazole Pinewood 15mg Gastro-resistant Capsules, Hard", "holder": "Pinewood Laboratories Limited", "authorised_date": "2013-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/151/002", "product_name": "Lansoprazole Pinewood 30mg Gastro-resistant Capsules, Hard", "holder": "Pinewood Laboratories Limited", "authorised_date": "2013-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/154/002", "product_name": "Losartan Potassium Pinewood 50 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2007-10-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/154/003", "product_name": "Losartan Potassium Pinewood 100 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2007-10-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/157/001", "product_name": "Rosuvastatin Pinewood 5 mg Film-coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/157/002", "product_name": "Rosuvastatin Pinewood 10 mg Film-coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/157/003", "product_name": "Rosuvastatin Pinewood 20 mg Film-coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/157/004", "product_name": "Rosuvastatin Pinewood 40 mg Film-coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/161/001", "product_name": "Doxycycline Pinewood 100 mg Capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2010-07-22", "product_type": "HM", 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"licence_number": "PA0281/220/001", "product_name": "Sitagliptin/Metformin hydrochloride Pinewood 50 mg/850 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin hydrochloride", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/220/002", "product_name": "Sitagliptin/Metformin hydrochloride Pinewood 50 mg/1000 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated 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application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/224/001", "product_name": "Ceftazidime 1g Powder for solution for injection or infusion", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2004-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/224/002", "product_name": "Ceftazidime 2g Powder for solution for injection or infusion", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2004-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", 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"legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/225/002", "product_name": "Ceftriaxone 2g Powder for Solution for Injection or Infusion", "holder": "Pinewood Laboratories Limited", "authorised_date": "2003-03-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/228/001", "product_name": "Flucloxacillin 250mg Powder for Solution for Injection or Infusion", "holder": "Pinewood Laboratories Limited", "authorised_date": "2008-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin sodium monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/228/002", "product_name": "Flucloxacillin 500mg Powder for Solution for Injection or Infusion", "holder": "Pinewood Laboratories Limited", "authorised_date": "2003-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin sodium monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/228/003", "product_name": "Flucloxacillin 1g Powder for Solution for Injection or Infusion", "holder": "Pinewood Laboratories Limited", "authorised_date": "2003-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin sodium monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/229/001", "product_name": 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"authorised_date": "1985-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B01AB", "B01AB01" ], "active_substances": [ "Heparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/230/001", "product_name": "Heparin Sodium 10 IU/ml flushing solution for maintenance of patency of intravenous devices", "holder": "Pinewood Laboratories Ltd", "authorised_date": "1985-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Irrigation solution", "atc_codes": [ "B01AB", "B01AB01" ], "active_substances": [ "Heparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product 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"product_name": "Oxycodone Hydrochloride 10 mg/ml Solution for Injection or Infusion", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2010-07-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/235/002", "product_name": "Oxycodone hydrochloride 50mg/ml solution for injection or infusion", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2013-08-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", 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"product_name": "Atorvastatin 20 mg Film-Coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2012-06-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/236/003", "product_name": "Atorvastatin 40 mg Film-Coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2012-06-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/236/004", "product_name": "Atorvastatin 80 mg Film-Coated Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2012-06-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/237/002", "product_name": "Dexamethasone phosphate 4mg/ml Solution for Injection or Infusion", "holder": "Pinewood Laboratories Limited", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/239/001", "product_name": "Oxytocin 10 IU/ml Concentrate for Solution for Infusion", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2014-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "H01BB", "H01BB02" ], "active_substances": [ "Oxytocin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may 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"product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB", "J01GB03" ], "active_substances": [ "Gentamicin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/244/001", "product_name": "Milrinone 1 mg/ml Solution for Injection/Infusion", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C01CE", "C01CE02" ], "active_substances": [ "Milrinone" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX", "J02AX04" ], "active_substances": [ "Caspofungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/248/001", "product_name": "Risperidone 1 mg/ml oral solution", "holder": "Pinewood Laboratories Limited", "authorised_date": "2008-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"Film-coated tablet", "atc_codes": [ "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/257/001", "product_name": "Zopiclone Pinewood 7.5 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2022-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/257/002", "product_name": "Zopiclone Pinewood 3.75 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/258/001", "product_name": "Ticagrelor Pinewood 90 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-08-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/262/004", "product_name": "Escitalopram Pinewood 20 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/263/001", "product_name": "Furosemide Pinewood 20 mg Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/263/002", "product_name": "Furosemide Pinewood 40 mg Tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be 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"market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/264/003", "product_name": "Bisoprolol fumarate Pinewood 3.75 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2024-02-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/264/004", "product_name": "Bisoprolol fumarate Pinewood 5 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2024-02-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/264/005", "product_name": "Bisoprolol fumarate Pinewood 7.5 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2024-02-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/264/006", "product_name": "Bisoprolol fumarate Pinewood 10 mg film-coated tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2024-02-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/265/001", "product_name": "Melnite 2 mg prolonged-release tablets", "holder": "Pinewood Laboratories Ltd", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/266/001", "product_name": "Rivaroxaban Pinewood 10 mg film coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/266/002", "product_name": "Rivaroxaban Pinewood 15 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/266/003", "product_name": "Rivaroxaban Pinewood 20 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/267/001", "product_name": "Bulexin 2 mg/0.5 mg sublingual tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC51" ], "active_substances": [ "Buprenorphine hydrochloride", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/267/002", "product_name": "Bulexin 4 mg/1 mg sublingual tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC51" ], "active_substances": [ "Buprenorphine hydrochloride", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/267/003", "product_name": "Bulexin 8 mg/2 mg sublingual tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC51" ], "active_substances": [ "Buprenorphine hydrochloride", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/268/001", "product_name": "Caprin 75 mg gastro-resistant tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "B01AC06" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/269/001", "product_name": "Lercanidipine Hydrochloride Pinewood 10 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2025-05-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/269/002", "product_name": "Lercanidipine Hydrochloride Pinewood 20 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2025-05-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/270/001", "product_name": "Duloxetine Pinewood 30 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/270/002", "product_name": "Duloxetine Pinewood 60 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/271/001", "product_name": "Clopidogrel Pinewood 75 mg film-coated tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC04" ], "active_substances": [ "Clopidogrel Hydrogen Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/272/001", "product_name": "Loseina 10 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/272/002", "product_name": "Loseina 20 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/272/003", "product_name": "Loseina 40 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/273/001", "product_name": "Esomeprazole Pinewood 20 mg gastro-resistant tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/273/002", "product_name": "Esomeprazole Pinewood 40 mg gastro-resistant tablets", "holder": "Pinewood Laboratories Limited", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/274/001", "product_name": "Aripiprazole Pinewood 1 mg/ml Oral Solution", "holder": "Pinewood Laboratories Limited", "authorised_date": "2025-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/276/001", "product_name": "Esomeprazole Pinewood 20 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0281/276/002", "product_name": "Esomeprazole Pinewood 40 mg hard gastro-resistant capsules", "holder": "Pinewood Laboratories Limited", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0298/010/001", "product_name": "Pinamox 125 mg/5 ml powder for oral suspension", "holder": "Athlone Laboratories Limited", "authorised_date": "1988-05-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0298/010/002", "product_name": "Pinamox 250 mg/5 ml powder for oral suspension", "holder": "Athlone Laboratories Limited", "authorised_date": "1988-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0298/010/003", "product_name": "Pinamox 250 mg hard capsules", "holder": "Athlone Laboratories Limited", "authorised_date": "1988-06-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0298/010/004", "product_name": "Pinamox 500 mg hard capsules", "holder": "Athlone Laboratories Limited", "authorised_date": "1988-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0298/016/001", "product_name": "Flucloxacillin 250 mg Capsules", "holder": "Athlone Laboratories Limited", "authorised_date": "2011-10-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0298/016/002", "product_name": "Flucloxacillin 500 mg capsules", "holder": "Athlone Laboratories Limited", "authorised_date": "2011-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0328/001/001", "product_name": "Instillagel 6 ml Urethral, vaginal, rectal and oropharyngeal gel", "holder": "Farco-Pharma GmbH", "authorised_date": "1981-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur.", "Methyl parahydroxybenzoate", "Propyl parahydroxybenzoate", "Lidocaine hydrochloride" ], "routes": [ "Urethral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0328/001/002", "product_name": "Instillagel® 11 ml Urethral, vaginal, rectal and oropharyngeal gel", "holder": "Farco-Pharma GmbH", "authorised_date": "1981-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur.", "Methyl parahydroxybenzoate", "Propyl parahydroxybenzoate", "Lidocaine hydrochloride" ], "routes": [ "Urethral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0329/011/001", "product_name": "NAVELBINE 20 mg soft capsule", "holder": "Pierre Fabre Medicament", "authorised_date": "2006-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01CA", "L01CA04" ], "active_substances": [ "Vinorelbine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0329/011/002", "product_name": "NAVELBINE 30 mg soft capsule", "holder": "Pierre Fabre Medicament", "authorised_date": "2006-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01CA", "L01CA04" ], "active_substances": [ "Vinorelbine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0345/001/001", "product_name": "Carbosylane 140mg/45mg Capsules", "holder": "Laboratoires Grimberg", "authorised_date": "1987-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule", "atc_codes": [], "active_substances": [ "Simeticone", "Charcoal, activated" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/009", "product_name": "Beclazone 50 micrograms CFC-Free Inhaler Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/010", "product_name": "Beclazone 100 micrograms CFC-Free Inhaler Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/011", "product_name": "Beclazone 200 micrograms CFC-Free Inhaler, Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/012", "product_name": "Beclazone 250 micrograms CFC-Free Inhaler Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/014", "product_name": "Beclazone 100 micrograms Easi-Breathe CFC-Free Inhaler Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/015", "product_name": "Beclazone 200 micrograms Easi-Breathe CFC-Free Inhaler, Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/021/016", "product_name": "Beclazone 250 micrograms Easi-Breathe CFC-Free Inhaler Pressurised Inhalation Solution", "holder": "Norton Waterford", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/032/001", "product_name": "Salamol CFC-Free Inhaler 100 micrograms pressurised inhalation, suspension", "holder": "Norton Waterford", "authorised_date": "2001-05-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/032/002", "product_name": "Salamol Easi-Breathe CFC-Free Inhaler 100 micrograms Pressurised Inhalation, Suspension", "holder": "Norton Waterford", "authorised_date": "2001-05-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AC02" ], "active_substances": [ "SALBUTAMOL SULFATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/046/001", "product_name": "Pravastatin Sodium 10 mg Tablets", "holder": "Norton Waterford", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/046/002", "product_name": "Pravastatin Sodium 20 mg Tablets", "holder": "Norton Waterford", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/046/003", "product_name": "Pravastatin Sodium 40 mg Tablets", "holder": "Norton Waterford", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/047/001", "product_name": "Fingolimod Teva 0.5 mg hard capsules", "holder": "Norton Waterford", "authorised_date": "2020-11-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "Fingolimod" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/048/001", "product_name": "Pirfenidone Teva 267 mg Film-coated Tablets", "holder": "Norton Waterford", "authorised_date": "2022-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/048/002", "product_name": "Pirfenidone Teva 801 mg Film-coated Tablets", "holder": "Norton Waterford", "authorised_date": "2022-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/049/001", "product_name": "Apixaban Teva 2.5 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2021-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/049/002", "product_name": "Apixaban Teva 5 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2021-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/050/001", "product_name": "Paliperidone Teva 25 mg prolonged-release suspension for injection", "holder": "Norton Waterford", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/050/002", "product_name": "Paliperidone Teva 50 mg prolonged-release suspension for injection", "holder": "Norton Waterford", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/050/003", "product_name": "Paliperidone Teva 75 mg prolonged-release suspension for injection", "holder": "Norton Waterford", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/050/004", "product_name": "Paliperidone Teva 100 mg prolonged-release suspension for injection", "holder": "Norton Waterford", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/050/005", "product_name": "Paliperidone Teva 150 mg prolonged-release suspension for injection", "holder": "Norton Waterford", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/050/006", "product_name": "Paliperidone Teva 150 mg and Paliperidone Teva 100 mg prolonged-release suspension for injection", "holder": "Norton Waterford", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate", "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/051/001", "product_name": "Sitagliptin/Metformin hydrochloride Teva 50 mg/850 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Hydrochloride Monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/051/002", "product_name": "Sitagliptin/Metformin hydrochloride Teva 50 mg/1000 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Hydrochloride Monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/054/001", "product_name": "Sudocrem Antiseptic Healing Cream", "holder": "Norton Waterford", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AB" ], "active_substances": [ "Benzyl alcohol", "Benzyl cinnamate", "Benzyl benzoate", "Wool fat", "Zinc oxide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/055/001", "product_name": "Dimethyl Fumarate 120 mg hard gastro-resistant capsules", "holder": "Norton Waterford", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/055/002", "product_name": "Dimethyl Fumarate 240 mg hard gastro-resistant capsules", "holder": "Norton Waterford", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/056/001", "product_name": "Macitentan Teva 10 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2025-05-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/057/001", "product_name": "Edoxaban Teva 15 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/057/002", "product_name": "Edoxaban Teva 30 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/057/003", "product_name": "Edoxaban Teva 60 mg film-coated tablets", "holder": "Norton Waterford", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/058/001", "product_name": "Dimethyl Fumarate Teva 120 mg gastro-resistant capsules, hard", "holder": "Norton Waterford", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/058/002", "product_name": "Dimethyl Fumarate Teva 240 mg gastro-resistant capsules, hard", "holder": "Norton Waterford", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/059/001", "product_name": "Mirabegron Teva 50 mg prolonged-release tablets", "holder": "Norton Waterford", "authorised_date": "2024-08-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD12" ], "active_substances": [ "Mirabegron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/060/001", "product_name": "Nintedanib Norton 100 mg soft capsules", "holder": "Norton Waterford", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0436/060/002", "product_name": "Nintedanib Norton 150 mg soft capsules", "holder": "Norton Waterford", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0484/021/001", "product_name": "Magnesium Sulfate 38.5% w/w Cutaneous Paste", "holder": "Foran Healthcare Limited,", "authorised_date": "1995-04-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous paste", "atc_codes": [ "D11AX", "D11AX05" ], "active_substances": [ "Magnesium sulfate dried" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0512/001/001", "product_name": "Fastum 2.5% w/w Gel", "holder": "A. Menarini Industrie Farmaceutische Riunite S.r.l.", "authorised_date": "1992-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA10" ], "active_substances": [ "Ketoprofen" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/021/001", "product_name": "Targocid 200mg Powder and Solvent for Solution for Injection/infusion or oral solution", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1990-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "J01XA", "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/021/002", "product_name": "Targocid 400mg Powder and Solvent for Solution for Injection/infusion or oral solution", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1990-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "J01XA", "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/023/001", "product_name": "Sabril 500 mg film-coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1989-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AG", "N03AG04" ], "active_substances": [ "Vigabatrin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/023/002", "product_name": "Sabril 500 mg Granules for Oral Solution", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1992-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "N03AG", "N03AG04" ], "active_substances": [ "Vigabatrin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/066/001", "product_name": "Rifadin 150mg Capsules", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1977-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J04AB", "J04AB02" ], "active_substances": [ "Rifampicin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/066/002", "product_name": "Rifadin 300mg Capsules", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1977-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J04AB", "J04AB02" ], "active_substances": [ "Rifampicin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/066/003", "product_name": "Rifadin Intravenous 600mg Powder and Solvent for Concentrate for Solution for Infusion", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1983-10-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for concentrate for solution for infusion", "atc_codes": [ "J04AB", "J04AB02" ], "active_substances": [ "Rifampicin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/066/004", "product_name": "Rifadin 100 mg/5 ml Oral Suspension", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1977-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J04AB", "J04AB02" ], "active_substances": [ "Rifampicin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/067/001", "product_name": "Rifater 50 mg/300 mg/120 mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1987-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J04AM", "J04AM05" ], "active_substances": [ "Isoniazid", "Pyrazinamide", "Rifampicin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/068/001", "product_name": "Rifinah 150/100 mg Film- Coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J04AM", "J04AM02" ], "active_substances": [ "Rifampicin", "Isoniazid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/068/002", "product_name": "Rifinah 300/150 mg Film Coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J04AM", "J04AM02" ], "active_substances": [ "Rifampicin", "Isoniazid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/082/001", "product_name": "Triapin 2.5mg/2.5mg prolonged release tablet", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C09BB", "C09BB05" ], "active_substances": [ "Felodipine", "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/082/002", "product_name": "Triapin 5mg/5mg prolonged release tablet", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C09BB", "C09BB05" ], "active_substances": [ "Felodipine", "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/084/005", "product_name": "TRITACE 1.25 mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2003-11-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/084/006", "product_name": "Tritace 2.5 mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2003-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/084/007", "product_name": "Tritace 5 mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2003-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/084/008", "product_name": "Tritace 10 mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2003-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/096/001", "product_name": "Cerubidin 20 mg Powder for Concentrate for Solution for Infusion", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01DB", "L01DB02" ], "active_substances": [ "Daunorubicin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/097/001", "product_name": "Clexane 10,000 IU (100mg)/1ml Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1989-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/097/002", "product_name": "Clexane Forte 15,000 IU (150mg)/1ml Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2001-06-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/097/004", "product_name": "Clexane 2,000 IU (20mg)/0.2 mL Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/097/005", "product_name": "Clexane 4,000 IU (40mg)/0.4 mL Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/097/006", "product_name": "Clexane 6,000 IU (60mg)/0.6 mL Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/097/007", "product_name": "Clexane 8,000 IU (80mg)/0.8 mL Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" }, { "licence_number": "PA0540/097/008", "product_name": "Clexane Forte 12,000 IU (120mg)/0.8 mL Solution for Injection in pre-filled syringes", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/101/002", "product_name": "Frumil 40mg/5mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1991-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03EB", "C03EB01" ], "active_substances": [ "Furosemide", "AMILORIDE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/139/001", "product_name": "Adenocor 3 mg/ml solution for injection", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1994-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01EB", "C01EB10" ], "active_substances": [ "Adenosine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/141/001", "product_name": "Calcium Resonium 99.934% Powder for oral or rectal suspension", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral/rectal suspension", "atc_codes": [ "V03AE", "V03AE01" ], "active_substances": [ "Calcium polystyrene sulphonate" ], "routes": [ "Oral use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/142/001", "product_name": "Cordarone X 100mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1984-07-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BD", "C01BD01" ], "active_substances": [ "Amiodarone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/142/002", "product_name": "Cordarone X 200mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1984-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BD", "C01BD01" ], "active_substances": [ "Amiodarone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/142/003", "product_name": "Cordarone X Intravenous, 150mg/3ml, Concentrate for solution for infusion or slow injection", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1984-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01BD", "C01BD01" ], "active_substances": [ "Amiodarone hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/001", "product_name": "Epilim 100 mg Crushable Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1984-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/002", "product_name": "Epilim Enteric 200 mg gastro-resistant coated tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1983-08-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/003", "product_name": "Epilim Enteric 500mg Gastro-resistant Coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1983-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/005", "product_name": "Epilim Chronosphere 100mg prolonged-release granules", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2007-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate", "Valproic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/006", "product_name": "Epilim Chronosphere 250mg prolonged-release granules", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2007-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate", "Valproic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/007", "product_name": "Epilim Chronosphere 500mg prolonged-release granules", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2007-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate", "Valproic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/010", "product_name": "Epilim Chrono 200mg Prolonged Release Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1992-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate", "Valproic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/011", "product_name": "Epilim Chrono 300mg Prolonged Release Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1992-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate", "Valproic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/012", "product_name": "Epilim Chrono 500mg Prolonged Release Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1992-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate", "Valproic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/013", "product_name": "Epilim Intravenous 400mg powder and solvent for solution for injection or infusion", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1998-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/014", "product_name": "Epilim Liquid 200 mg/5ml Oral Solution", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1984-03-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/150/015", "product_name": "Epilim Syrup 200mg/5ml Oral Solution", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1983-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AG", "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/155/001", "product_name": "Plaquenil 200mg Film-coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "P01BA", "P01BA02" ], "active_substances": [ "Hydroxychloroquine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/158/001", "product_name": "Solian 50mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AL", "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/158/002", "product_name": "Solian 100mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AL", "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/158/003", "product_name": "Solian 200mg Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AL", "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/158/004", "product_name": "Solian 400mg Film-coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AL", "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/160/001", "product_name": "Stilnoct 5 mg Film Coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1993-02-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/160/002", "product_name": "Stilnoct 10 mg Film-coated Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "1993-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/162/003", "product_name": "Xatral 10mg Prolonged Release Tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2000-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA01" ], "active_substances": [ "Alfuzosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/193/001", "product_name": "Suvezen 10 mg/10 mg film-coated tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2019-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA06" ], "active_substances": [ "Rosuvastatin", "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/193/002", "product_name": "Suvezen 20 mg/10 mg film-coated tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2019-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA06" ], "active_substances": [ "Rosuvastatin", "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0540/193/003", "product_name": "Suvezen 40 mg/10 mg film-coated tablets", "holder": "Sanofi-Aventis Ireland Limited T/A SANOFI", "authorised_date": "2019-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA06" ], "active_substances": [ "Rosuvastatin", "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/014/001", "product_name": "Suxamethonium Chloride 50 mg/ml solution for injection/infusion", "holder": "Ethypharm", "authorised_date": "2019-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M03AB01" ], "active_substances": [ "Suxamethonium chloride" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product 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injection in a pre-filled syringe", "holder": "Ethypharm", "authorised_date": "2016-06-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V03AB", "V03AB15" ], "active_substances": [ "Naloxone hydrochloride dihydrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/023/001", "product_name": "Morphine Sulfate 10mg/ml Solution for injection", "holder": "Ethypharm", "authorised_date": "2006-06-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/023/002", "product_name": "Morphine Sulfate 30mg/ml, Solution for injection", "holder": "Ethypharm", "authorised_date": "2006-06-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/024/001", "product_name": "Espranor 2 mg Oral 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"N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/027/001", "product_name": "Ephedrine Hydrochloride 30mg in 1ml Solution for Injection", "holder": "Ethypharm", "authorised_date": "2004-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/028/001", "product_name": "Glycerol 1g Suppositories", "holder": "Ethypharm", "authorised_date": "1993-02-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A06AX", "A06AX01" ], "active_substances": [ "Glycerol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/028/003", "product_name": "Glycerol 4g Suppositories", "holder": "Ethypharm", "authorised_date": "1991-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A06AX", "A06AX01" ], "active_substances": [ "Glycerol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/029/001", "product_name": "Glycopyrronium bromide 200 micrograms/ml Solution for injection", "holder": "Ethypharm", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A03AB", "A03AB02" ], "active_substances": [ "Glycopyrronium bromide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/030/001", "product_name": "Hydromorphone Hydrochloride 20 mg/ml Solution for Injection/Concentrate for Solution for Infusion", "holder": "Ethypharm", "authorised_date": "2005-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/030/002", "product_name": "Hydromorphone Hydrochloride 50 mg/ml Solution for Injection/Concentrate for Solution for Infusion", "holder": "Ethypharm", "authorised_date": "2005-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/031/002", "product_name": "Hyoscine Hydrobromide Martindale Pharma 600 micrograms/ml Solution for Injection", "holder": "Ethypharm", "authorised_date": "2005-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AD" ], "active_substances": [ "Hyoscine hydrobromide" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0549/032/001", "product_name": "Methadone Mixture DTF (Sugar Free) 1 mg in 1 ml Oral Solution", "holder": "Ethypharm", "authorised_date": "1996-01-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07BC", "N07BC02" ], "active_substances": [ "Methadone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/002/004", "product_name": "Coversyl Arginine 2.5 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2005-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/002/005", "product_name": "Coversyl Arginine 5 mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2005-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/002/006", "product_name": "Coversyl Arginine 10 mg film coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2005-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/005/001", "product_name": "Natrilix SR 1.5 mg, prolonged-release film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "1996-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C03BA", "C03BA11" ], "active_substances": [ "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/008/003", "product_name": "Coversyl Arginine Plus 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to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/013/002", "product_name": "DIAMICRON MR 60 mg modified-release tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2009-12-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "A10BB", "A10BB09" ], "active_substances": [ "Gliclazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/016/002", "product_name": "Coversyl Arginine Plus 5mg/1.25mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2007-05-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BA", "C09BA04" ], "active_substances": [ "Perindopril arginine", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/018/001", "product_name": "Acerycal 5mg/5mg tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2008-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/018/002", "product_name": "Acerycal 5mg/10mg tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2008-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/018/003", "product_name": "Acerycal 10mg/5mg tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2008-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/018/004", "product_name": "Acerycal 10mg/10mg tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2008-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/022/002", "product_name": "Coversyl Arginine Plus 10mg/2.5mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2009-08-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BA", "C09BA04" ], "active_substances": [ "Perindopril arginine", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/024/002", "product_name": "Coverdine 5mg/1.25mg/5mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2014-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/024/003", "product_name": "Coverdine 5mg/1.25mg/10mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2014-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/024/004", "product_name": "Coverdine 10mg/2.5mg/5mg film-coated tablets", "holder": "Les Laboratoires 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"Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/027/001", "product_name": "Viacoram 3.5mg/2.5mg Tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB", "C09BB04" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/027/002", "product_name": "Viacoram 7mg/5mg Tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB", "C09BB04" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/028/001", "product_name": "Lipertance 10mg/5mg/5mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2015-10-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BX", "C10BX11" ], "active_substances": [ "Atorvastatin calcium", "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply 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"market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BX", "C10BX11" ], "active_substances": [ "Atorvastatin calcium", "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/028/004", "product_name": "Lipertance 20mg/10mg/10mg film-coated tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2015-10-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BX", "C10BX11" ], "active_substances": [ "Atorvastatin calcium", "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which 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"2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX02" ], "active_substances": [ "BISOPROLOL FUMARATE", "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/029/002", "product_name": "Cosimprel 5mg/10mg Film-Coated Tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX02" ], "active_substances": [ "BISOPROLOL FUMARATE", "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/029/003", "product_name": "Cosimprel 10mg/5mg Film-Coated Tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX02" ], "active_substances": [ "BISOPROLOL FUMARATE", "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/029/004", "product_name": "Cosimprel 10mg/10mg Film-Coated Tablets", "holder": "Les Laboratoires Servier", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX02" ], "active_substances": [ "BISOPROLOL FUMARATE", "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0568/033/001", "product_name": "Vastarel 20 mg Film-coated Tablets", "holder": "Les Laboratoires Servier", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB15" ], "active_substances": [ "Trimetazidine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/002/001", "product_name": "Budenofalk 3 mg gastro-resistant capsules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A07EA", "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/002/002", "product_name": "Budenofalk 2mg/dose rectal foam", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2009-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal foam", "atc_codes": [ "A07EA", "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/002/003", "product_name": "Budenofalk® 9mg gastro-resistant granules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2011-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant granules", "atc_codes": [ "A07EA", "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/003/001", "product_name": "Salofalk 500 mg prolonged-release granules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2003-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/003/002", "product_name": "Salofalk 1000mg prolonged-release granules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2003-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/003/006", "product_name": "Salofalk 3g prolonged-release granules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2011-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/003/007", "product_name": "Salofalk 1.5g prolonged-release granules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2013-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/004/001", "product_name": "Salofalk 4g/60ml Enema", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "1989-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal suspension", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/004/002", "product_name": "Salofalk 250 mg Suppositories", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "1989-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/004/004", "product_name": "Salofalk 1g Suppositories", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2010-06-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/004/005", "product_name": "Salofalk 1g/Actuation Rectal Foam", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2009-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal foam", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/005/001", "product_name": "Ursofalk 250 mg Hard Capsules", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "1984-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/005/002", "product_name": "Ursofalk 250 mg/5 ml Suspension", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2011-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/005/003", "product_name": "Ursofalk 500mg film-coated tablets", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2011-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0573/008/001", "product_name": "Budenofalk 4 mg suppositories", "holder": "Dr. Falk Pharma GmbH", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0577/057/001", "product_name": "Areloger 7.5 mg tablets", "holder": "McDermott Laboratories Ltd., T/A Gerard Laboratories", "authorised_date": "2004-09-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M01AC", "M01AC06" ], "active_substances": [ "Meloxicam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0577/057/002", "product_name": "Areloger 15 mg tablets", "holder": "McDermott Laboratories Ltd., T/A Gerard Laboratories", "authorised_date": "2004-09-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M01AC", "M01AC06" ], "active_substances": [ "Meloxicam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0577/193/001", "product_name": "Abacavir/Lamivudine Mylan 600 mg/300 mg film-coated tablets", "holder": "McDermott Laboratories Ltd., T/A Gerard Laboratories", "authorised_date": "2016-10-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR02" ], "active_substances": [ "Abacavir", "Lamivudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/003/001", "product_name": "Becloneb 400 micrograms/1 ml nebuliser suspension", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-03-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/003/002", "product_name": "Becloneb 800 micrograms/2 ml nebuliser suspension", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-03-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/004/001", "product_name": "Beclospin 400 micrograms/1 ml nebuliser suspension", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-03-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate anhydrous" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/004/002", "product_name": "Beclospin 800 micrograms/2 ml 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[ "Endotracheopulmonary use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/005/002", "product_name": "CUROSURF 240 mg/vial Endotracheopulmonary instillation, suspension", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "1994-09-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Endotracheopulmonary instillation, suspension", "atc_codes": [ "R07AA", "R07AA02" ], "active_substances": [ "Porcine lung surfactant" ], "routes": [ "Endotracheopulmonary use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/006/001", "product_name": "Clenil Modulite 50 micrograms per metered dose Pressurised Inhalation Solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/006/002", "product_name": "Clenil Modulite 100 micrograms per metered dose Pressurised Inhalation Solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/006/003", "product_name": "Clenil Modulite 200 micrograms per metered dose Pressurised Inhalation Solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/006/004", "product_name": "Clenil Modulite 250 micrograms per metered dose Pressurised Inhalation Solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/007/001", "product_name": "Bramitob 300mg/4ml Nebuliser Solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "J01GB", "J01GB01" ], "active_substances": [ "Tobramycin" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/008/001", "product_name": "Fostair 100 microgram/6 microgram per actuation pressurised inhalation solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2017-09-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AK08" ], "active_substances": [ "Beclometasone dipropionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/008/002", "product_name": "Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2018-01-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK", "R03AK08" ], "active_substances": [ "Beclometasone dipropionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/008/003", "product_name": "Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AK", "R03AK08" ], "active_substances": [ "Beclometasone dipropionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0584/008/004", "product_name": "Fostair Nexthaler 200 micrograms/6 micrograms per metered dose inhalation powder", "holder": "Chiesi Farmaceutici S.p.A.", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK", "R03AK08" ], "active_substances": [ "Formoterol fumarate dihydrate", "Beclometasone dipropionate anhydrous" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0592/005/004", "product_name": "Hepatect CP 50 IU/ml solution for infusion", "holder": "Biotest Pharma GmbH", "authorised_date": "2008-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BB", "J06BB04" ], "active_substances": [ "Human plasma protein", "Hbs antibodies" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0592/007/001", "product_name": "Intratect 50 g/L, solution for infusion", "holder": "Biotest Pharma GmbH", "authorised_date": "2006-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Human plasma protein >96% immunoglobulins" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0592/007/002", "product_name": "Intratect 100 g/L, solution for infusion", "holder": "Biotest Pharma GmbH", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Human plasma protein" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0592/008/001", "product_name": "Megalotect 100 U/mL solution for infusion", "holder": "Biotest Pharma GmbH", "authorised_date": "2022-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BB09" ], "active_substances": [ "Human Cytomegalovirus Immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0592/009/001", "product_name": "Yimmugo", "holder": "Biotest Pharma GmbH", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA02" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/042/004", "product_name": "APO-go POD 5 mg/ml solution for infusion in cartridge", "holder": "Stada Arzneimittel AG", "authorised_date": "2020-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion in cartridge", "atc_codes": [ "N04BC07" ], "active_substances": [ "Apomorphine hydrochloride hemihydrate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/043/001", "product_name": "APO-go® PEN 10 mg/ml Solution for Injection** Abbreviated to APO-go in the text", "holder": "Stada Arzneimittel AG", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N04BC", "N04BC07" ], "active_substances": [ "Apomorphine hydrochloride" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/043/002", "product_name": "APO-go AMPOULES 10 mg/ml Solution for Injection or Infusion *Abbreviated to APO-go in the text", "holder": "Stada Arzneimittel AG", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N04BC", "N04BC07" ], "active_substances": [ "Apomorphine hydrochloride" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/043/003", "product_name": "APO-go® PFS 5mg/ml Solution for Infusion in Pre-filled Syringe", "holder": "Stada Arzneimittel AG", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion in pre-filled syringe", "atc_codes": [ "N04BC", "N04BC07" ], "active_substances": [ "Apomorphine hydrochloride" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/047/001", "product_name": "Sildenafil STADA 25 mg Chewable tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/047/002", "product_name": "Sildenafil STADA 50 mg Chewable tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/047/003", "product_name": "Sildenafil STADA 100mg Chewable tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/048/001", "product_name": "Sildenafil STADA Arzneimittel AG 25 mg Chewable tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/048/002", "product_name": "Sildenafil STADA Arzneimittel AG 50 mg chewable tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/048/003", "product_name": "Sildenafil STADA Arzneimittel AG 100 mg Chewable tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/051/001", "product_name": "Lenvatinib STADA 4 mg hard capsules", "holder": "Stada Arzneimittel AG", "authorised_date": "2026-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX08" ], "active_substances": [ "Lenvatinib mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/051/002", "product_name": "Lenvatinib STADA 10 mg hard capsules", "holder": "Stada Arzneimittel AG", "authorised_date": "2026-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX08" ], "active_substances": [ "Lenvatinib mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/053/001", "product_name": "Tofacitinib STADA 5 mg film-coated tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2026-07-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AF01" ], "active_substances": [ "Tofacitinib citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0593/053/002", "product_name": "Tofacitinib STADA 10 mg film-coated tablets", "holder": "Stada Arzneimittel AG", "authorised_date": "2026-07-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AF01" ], "active_substances": [ "Tofacitinib citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0599/005/001", "product_name": "Nortriptyline 10 mg Film-coated Tablets", "holder": "Pharmafile Limited", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA10" ], "active_substances": [ "Nortriptyline" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0599/005/002", "product_name": "Nortriptyline 25 mg Film-coated Tablets", "holder": "Pharmafile Limited", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA", "N06AA10" ], "active_substances": [ "Nortriptyline" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0611/003/001", "product_name": "Thymoglobuline 25 mg powder for solution for infusion", "holder": "Sanofi B.V.", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L04AA", "L04AA04" ], "active_substances": [ "Rabbit anti-human thymocyte immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0611/004/002", "product_name": "Fludara 10 mg film-coated tablets", "holder": "Sanofi B.V.", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01BB", "L01BB05" ], "active_substances": [ "Fludarabine phosphate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/003/002", "product_name": "Dacarbazine medac 200 mg, powder for solution for injection/infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01AX", "L01AX04" ], "active_substances": [ "Dacarbazine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/003/003", "product_name": "Dacarbazine medac 500 mg, powder for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AX", "L01AX04" ], "active_substances": [ "Dacarbazine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/003/004", "product_name": "Dacarbazine medac 1000 mg, powder for solution for infusion", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AX", "L01AX04" ], "active_substances": [ "Dacarbazine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/004/001", "product_name": "BCG medac, powder and solvent for intravesical suspension", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2002-04-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for intravesical suspension", "atc_codes": [ "L03AX", "L03AX03" ], "active_substances": [ "Bacillus Calmette Guérin (BCG)" ], "routes": [ "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/014/002", "product_name": "Metoject 7.5 mg solution for injection in pre-filled pen", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/014/003", "product_name": "Metoject 10 mg solution for injection in pre-filled pen", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/014/004", "product_name": "Metoject 15 mg solution for injection in pre-filled pen", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/014/005", "product_name": "Metoject 20 mg solution for injection in pre-filled pen", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/014/006", "product_name": "Metoject 25 mg solution for injection in pre-filled pen", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/016/002", "product_name": "Mitomycin medac 40 mg powder and solvent for intravesical solution", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2016-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for intravesical solution", "atc_codes": [ "L01DC", "L01DC03" ], "active_substances": [ "Mitomycin" ], "routes": [ "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0623/018/001", "product_name": "Bortezomib medac 3.5 mg powder for solution for injection", "holder": "medac Gesellschaft für klinische Spezialpräparate mbH", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX", "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0677/003/001", "product_name": "PULMOCIS 2 mg kit for radiopharmaceutical preparation", "holder": "CIS bio International", "authorised_date": "2001-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Human albumin macro aggregated" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0677/005/001", "product_name": "RENOCIS 1 mg kit for radiopharmaceutical preparation", "holder": "CIS bio International", "authorised_date": "1999-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09CA", "V09CA02" ], "active_substances": [ "Succimer" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0677/018/001", "product_name": "STAMICIS 1mg kit for radiopharmaceutical preparation", "holder": "CIS bio International", "authorised_date": "2008-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09GA", "V09GA01" ], "active_substances": [ "Tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/002/001", "product_name": "Corsodyl 1% w/w Dental Gel", "holder": "Haleon Ireland Limited", "authorised_date": "1975-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dental gel", "atc_codes": [ "A01AB", "A01AB03" ], "active_substances": [ "Chlorhexidine digluconate" ], "routes": [ "Dental use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/002/004", "product_name": "Corsodyl 0.2% w/v Aniseed Mouthwash", "holder": "Haleon Ireland Limited", "authorised_date": "1995-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Mouthwash", "atc_codes": [ "A01AB", "A01AB03" ], "active_substances": [ "Chlorhexidine digluconate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/002/005", "product_name": "Corsodyl Freshmint 0.2% w/v Mouthwash", "holder": "Haleon Ireland Limited", "authorised_date": "2012-02-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Mouthwash", "atc_codes": [ "A01AB", "A01AB03" ], "active_substances": [ "Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur." ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/011/001", "product_name": "Panadol Cold & Flu Hot Lemon Powder for Oral SolutionParacetamol 600mgAscorbic acid 40mg", "holder": "Haleon Ireland Limited", "authorised_date": "1987-10-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/011/002", "product_name": "Panadol Cold & Flu Hot Blackcurrant Powder for Oral SolutionParacetamol 600mgAscorbic acid 40mg", "holder": "Haleon Ireland Limited", "authorised_date": "1987-10-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/011/003", "product_name": "Panadol Cold & Flu Hot Lemon with Honey Powder for Oral SolutionParacetamol 600mgAscorbic acid 40mg", "holder": "Haleon Ireland Limited", "authorised_date": "1990-05-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/011/004", "product_name": "Panadol Max Strength Cold & Flu Hot Berry plus Vitamin C Powder for Oral Solution Paracetamol 1000 mg Ascorbic Acid 70 mg", "holder": "Haleon Ireland Limited", "authorised_date": "2009-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/014/001", "product_name": "Night Nurse Cold Remedy oral solution Paracetamol 1000 mg/20 ml Promethazine Hydrochloride 20 mg/20 ml Dextromethorphan Hydrobromide 15 mg/20 ml", "holder": "Haleon Ireland Limited", "authorised_date": "1990-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Promethazine hydrochloride", "Dextromethorphan hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/021/001", "product_name": "Night Nurse Capsules Paracetamol 500 mg Promethazine Hydrochloride 10 mg Dextromethorphan Hydrobromide 7.5 mg", "holder": "Haleon Ireland Limited", "authorised_date": "1990-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE51" ], "active_substances": [ "Dextromethorphan hydrobromide", "Promethazine hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/026/003", "product_name": "Panadeine Extra Strength Tablets Paracetamol 500 mg Codeine Phosphate hemihydrate 12.8 mg", "holder": "Haleon Ireland Limited", "authorised_date": "2012-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/027/001", "product_name": "Panadol Extra Film-coated tablets Paracetamol 500mg Caffeine 65mg", "holder": "Haleon Ireland Limited", "authorised_date": "1994-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/028/002", "product_name": "Panadol Soluble Max 1000mg Paracetamol Effervescent granules", "holder": "Haleon Ireland Limited", "authorised_date": "1992-08-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent granules", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/035/001", "product_name": "Panadol Max Strength Fever and Congestion Hot Lemon Powder for Oral SolutionParacetamol 1000mgPhenylephrine hydrochloride 10mgAscorbic Acid 40mg", "holder": "Haleon Ireland Limited", "authorised_date": "1999-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Phenylephrine hydrochloride", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/037/001", "product_name": "Panadol with Caffeine 500mg/ 65mg Film Coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "1997-06-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/003", "product_name": "Panadol Baby 120 mg/5 ml, Oral Suspension", "holder": "Haleon Ireland Limited", "authorised_date": "1992-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/005", "product_name": "Panadol Original 500 mg film-coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/008", "product_name": "Panadol Night", "holder": "Haleon Ireland Limited", "authorised_date": "1998-09-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Diphenhydramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/009", "product_name": "Panagram Max 1g Film coated tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2003-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/010", "product_name": "Panadol Extra 500mg/65mg Soluble Effervescent Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2001-11-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/012", "product_name": "Panadol Actifast Tablets 500mg", "holder": "Haleon Ireland Limited", "authorised_date": "2001-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/013", "product_name": "Panadol Max Strength Cold and Flu Hot Lemon Powder for oral solution Paracetamol 1000mg", "holder": "Haleon Ireland Limited", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/014", "product_name": "Panadol ActiFast 500mg Soluble Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2007-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/039/017", "product_name": "Panadol Actifast Lemon 500 mg Soluble Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2022-10-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/043/001", "product_name": "Andrews Liver Salts Effervescent Powder", "holder": "Haleon Ireland Limited", "authorised_date": "1992-02-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent powder", "atc_codes": [ "A06AD", "A06AD04", "A09AB", "A09AB04" ], "active_substances": [ "Sodium hydrogen carbonate", "Magnesium sulphate dihydrate", "Citric acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/044/001", "product_name": "Panadol Sinus Relief Film Coated TabletsParacetamol 500mgCaffeine 25mgPhenylephrine Hydrochloride 5mg", "holder": "Haleon Ireland Limited", "authorised_date": "1992-08-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine", "Phenylephrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/061/002", "product_name": "Actiprofen 200 mg tablets", "holder": "Haleon Ireland Limited", "authorised_date": "1992-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/080/001", "product_name": "Piriton Allergy 4mg Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "1985-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AB", "R06AB04" ], "active_substances": [ "Chlorpheniramine maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/090/002", "product_name": "Zovirax Cold Sore 5% w/w Cream", "holder": "Haleon Ireland Limited", "authorised_date": "1993-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB03" ], "active_substances": [ "Aciclovir" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/094/001", "product_name": "Panadol Fever and Congestion Film-coated Tablets Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg", "holder": "Haleon Ireland Limited", "authorised_date": "2003-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/095/001", "product_name": "Flixonase Allergy Relief 50 micrograms per dose Nasal Spray", "holder": "Haleon Ireland Limited", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD08" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Intranasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/102/001", "product_name": "Panadol Woman Film-Coated TabletsParacetamol 500 mg Caffeine 65 mg", "holder": "Haleon Ireland Limited", "authorised_date": "2009-11-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/105/001", "product_name": "Panadol Cold and Flu Relief 500mg/65mg Film-Coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2007-05-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/105/002", "product_name": "Panadol Cold and Flu Relief Orange Effervescent TabletsParacetamol 500 mgCaffeine 65 mg", "holder": "Haleon Ireland Limited", "authorised_date": "2015-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/106/001", "product_name": "Panadol Head Cold Powder for Oral SolutionParacetamol 600 mg Ascorbic Acid 40 mg", "holder": "Haleon Ireland Limited", "authorised_date": "2006-10-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/107/001", "product_name": "Panadol 500 mg Film Coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2006-08-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/118/001", "product_name": "Fluticasone propionate 50 micrograms/actuation, nasal spray, suspension", "holder": "Haleon Ireland Limited", "authorised_date": "2015-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD08" ], "active_substances": [ "Fluticasone propionate (micronised)" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/120/001", "product_name": "Otrivine Adult 0.1% w/v Nasal Drops, Solution", "holder": "Haleon Ireland Limited", "authorised_date": "1984-05-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal drops, solution", "atc_codes": [ "R01AA", "R01AA07" ], "active_substances": [ "Xylometazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/120/002", "product_name": "Otrivine Congestion Relief 0.1% w/v Nasal Spray, Solution", "holder": "Haleon Ireland Limited", "authorised_date": "1984-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AA", "R01AA07" ], "active_substances": [ "Xylometazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/120/003", "product_name": "Otrivine Sinusitis Relief 0.1% w/v Nasal Spray, Solution", "holder": "Haleon Ireland Limited", "authorised_date": "1991-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AA", "R01AA07" ], "active_substances": [ "Xylometazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/120/004", "product_name": "Otrivine Adult Menthol 0.1% w/v Nasal Spray, Solution", "holder": "Haleon Ireland Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AA", "R01AA07" ], "active_substances": [ "Xylometazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/120/005", "product_name": "Otrivine Congestion Relief Menthol 0.1% w/v Nasal Spray", "holder": "Haleon Ireland Limited", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AA", "R01AA07" ], "active_substances": [ "Xylometazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/122/001", "product_name": "Excedrin 250 mg/ 250 mg/ 65 mg film coated tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2010-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Acetylsalicylic acid", "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/131/001", "product_name": "Otrivine Extra Dual Relief 0.5mg/ml + 0.6mg/ml nasal spray, solution", "holder": "Haleon Ireland Limited", "authorised_date": "2012-12-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AB", "R01AB06" ], "active_substances": [ "Xylometazoline hydrochloride", "Ipratropium bromide" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/139/001", "product_name": "Savlon Antiseptic Liquid", "holder": "Haleon Ireland Limited", "authorised_date": "1991-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for cutaneous solution", "atc_codes": [ "D08AJ", "D08AJ04" ], "active_substances": [ "Chlorhexidine gluconate", "Cetrimide" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/140/001", "product_name": "Voltarol 1% w/w Gel", "holder": "Haleon Ireland Limited", "authorised_date": "1989-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac diethylammonium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/140/002", "product_name": "Voltarol Emulgel 1% w/w Gel", "holder": "Haleon Ireland Limited", "authorised_date": "2003-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac diaethylammonium" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/140/003", "product_name": "Voltarol Emulgel Extra Strength 2% w/w gel", "holder": "Haleon Ireland Limited", "authorised_date": "2014-02-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/140/004", "product_name": "Voltarol Muscle & Joint Pain Relief 140 mg medicated plaster", "holder": "Haleon Ireland Limited", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/143/001", "product_name": "Zovirax Duo 50 mg/g and 10 mg/g Cream", "holder": "Haleon Ireland Limited", "authorised_date": "2017-04-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB53" ], "active_substances": [ "ACICLOVIR PH. EUR.", "HYDROCORTISONE PH. EUR." ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/146/001", "product_name": "Advil Liquid 200mg Soft capsules", "holder": "Haleon Ireland Limited", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/147/001", "product_name": "Advil Cold & Flu Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg", "holder": "Haleon Ireland Limited", "authorised_date": "1994-09-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE", "M01AE51" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/147/002", "product_name": "Advil Cold & Flu Relief Soft Capsules Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg", "holder": "Haleon Ireland Limited", "authorised_date": "2016-03-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE", "M01AE51" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/148/001", "product_name": "Anadin Analgesic Film-coated Tablets Aspirin 325mg Caffeine 15mg", "holder": "Haleon Ireland Limited", "authorised_date": "1983-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BA", "N02BA51" ], "active_substances": [ "Aspirin", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/148/002", "product_name": "Anadin Maximum Strength Hard Capsules Aspirin 500mg, caffeine 32mg", "holder": "Haleon Ireland Limited", "authorised_date": "1984-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BA", "N02BA51" ], "active_substances": [ "Caffeine", "Aspirin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/150/001", "product_name": "Paracetamol 500 mg Film Coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "1989-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/151/001", "product_name": "Paraeze Hard Capsules Paracetamol 500mg Caffeine 32mg", "holder": "Haleon Ireland Limited", "authorised_date": "1982-12-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Caffeine", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/152/001", "product_name": "Paraextra Hard CapsulesParacetamol 500mgCaffeine 32mg", "holder": "Haleon Ireland Limited", "authorised_date": "2005-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/153/001", "product_name": "Robitussin Chesty Cough 100 mg/5 ml Oral Solution", "holder": "Haleon Ireland Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CA", "R05CA03" ], "active_substances": [ "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/154/001", "product_name": "Robitussin Plus Oral Solution Guaifenesin 100 mg/5ml Pseudoephedrine HCl 30 mg/5ml", "holder": "Haleon Ireland Limited", "authorised_date": "1985-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R01BA", "R01BA52" ], "active_substances": [ "Guaiphenesin", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/155/001", "product_name": "Robitussin Dry Cough 7.5mg/5ml Oral Solution", "holder": "Haleon Ireland Limited", "authorised_date": "1985-12-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05DA09" ], "active_substances": [ "Dextromethorphan hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/156/001", "product_name": "Caltrate 600 mg/400 IU, Film-coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2009-04-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium", "Cholecalciferol concentrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/160/001", "product_name": "Paracetamol/Ibuprofen Haleon 500 mg/200 mg film-coated tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE51" ], "active_substances": [ "Ibuprofen", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/161/001", "product_name": "Cetirizine Haleon Pharma 1 mg/ml oral solution", "holder": "Haleon Ireland Limited", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/162/001", "product_name": "Cetirizine dihydrochloride Haleon 1 mg/ml oral solution", "holder": "Haleon Ireland Limited", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/162/002", "product_name": "Cetirizine Haleon 10mg Film Coated Tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0678/163/001", "product_name": "Flixrelief 120 mg film-coated tablets", "holder": "Haleon Ireland Limited", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/002/001", "product_name": "Xenetix 250mg I/ml Solution for Injection", "holder": "Guerbet", "authorised_date": "1996-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB11" ], "active_substances": [ "Iobitridol" ], "routes": [ "Intraarterial use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/002/002", "product_name": "Xenetix 300mg I/ml Solution for Injection", "holder": "Guerbet", "authorised_date": "1996-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB11" ], "active_substances": [ "Iobitridol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/002/003", "product_name": "Xenetix 350mg I/ml Solution for Injection", "holder": "Guerbet", "authorised_date": "1996-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB11" ], "active_substances": [ "Iobitridol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/002/004", "product_name": "Xenetix 300mg I/ml Solution for injection, polypropylene bag", "holder": "Guerbet", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB11" ], "active_substances": [ "Iobitridol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/002/005", "product_name": "Xenetix 350mg I/ml Solution for injection, polypropylene bag", "holder": "Guerbet", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB11" ], "active_substances": [ "Iobitridol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/003/002", "product_name": "Dotarem 279.32 mg/ml solution for injection", "holder": "Guerbet", "authorised_date": "1996-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA02" ], "active_substances": [ "Gadoteric acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/003/005", "product_name": "Dotarem 279.32 mg/ml solution for injection in pre-filled syringe", "holder": "Guerbet", "authorised_date": "1996-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V08CA", "V08CA02" ], "active_substances": [ "Gadoteric acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/004/001", "product_name": "Lipiodol Ultra Fluid 480 mg I/mL Solution for injection", "holder": "Guerbet", "authorised_date": "1996-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AD" ], "active_substances": [ "organically combined iodine." ], "routes": [ "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/007/003", "product_name": "Optiray 300 mg I/ml solution for injection or infusion", "holder": "Guerbet", "authorised_date": "1993-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V08AB", "V08AB07" ], "active_substances": [ "Ioversol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/007/004", "product_name": "Optiray 300 mg I/ml PFS solution for injection", "holder": "Guerbet", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB07" ], "active_substances": [ "Ioversol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/007/005", "product_name": "Optiray 320 mg I/ml solution for injection or infusion", "holder": "Guerbet", "authorised_date": "1993-04-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V08AB", "V08AB07" ], "active_substances": [ "Ioversol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/007/006", "product_name": "Optiray 350 mg I/ml solution for injection or infusion", "holder": "Guerbet", "authorised_date": "1993-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V08AB", "V08AB07" ], "active_substances": [ "Ioversol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0686/007/007", "product_name": "Optiray 350 mg I/ml PFS solution for injection", "holder": "Guerbet", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB07" ], "active_substances": [ "Ioversol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/014/001", "product_name": "Bisoprolol Fumarate 1.25mg Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/014/002", "product_name": "Bisoprolol Fumarate 2.5 mg Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/014/003", "product_name": "Bisoprolol Fumarate 3.75 mg Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/014/004", "product_name": "Bisoprolol Fumarate 5 mg Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/014/005", "product_name": "Bisoprolol Fumarate 10 mg Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/017/001", "product_name": "Fexofenadine hydrochloride 120 mg Film-coated tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/017/002", "product_name": "Fexofenadine hydrochloride 180 mg Film-coated Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/027/001", "product_name": "Frovatriptan 2.5mg Film-coated Tablets", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2013-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC07" ], "active_substances": [ "Frovatriptan succinate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/041/001", "product_name": "Escitalopram 20mg/ml Oral drops, solution", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2012-03-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/048/001", "product_name": "Eletriptan 20mg Film-coated tablet", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC06" ], "active_substances": [ "ELETRIPTAN" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/048/002", "product_name": "Eletriptan 40mg Film-coated tablet", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC06" ], "active_substances": [ "ELETRIPTAN" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0688/064/001", "product_name": "Pregabalin 20 mg/ml oral solution", "holder": "Chanelle Medical Unlimited Company", "authorised_date": "2020-07-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/001/001", "product_name": "Octreoscan 111 MBq/mL, kit for radiopharmaceutical preparation", "holder": "Curium Netherlands B.V.", "authorised_date": "1995-06-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09AX01" ], "active_substances": [ "Indium (111 in) chloride solution", "Pentetreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/003/001", "product_name": "Gallium (Ga67) Citrate injection", "holder": "Curium Netherlands B.V.", "authorised_date": "2000-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09HX", "V09HX01" ], "active_substances": [ "Gallium (67 ga) citrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/004/001", "product_name": "TechneScan HDP 3mg, kit for radiopharmaceutical preparation", "holder": "Curium Netherlands B.V.", "authorised_date": "1993-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09BA", "V09BA01" ], "active_substances": [ "Oxidronate disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/005/001", "product_name": "MIBG (123I) 74 MBq/mL solution for injection", "holder": "Curium Netherlands B.V.", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09IX", "V09IX01" ], "active_substances": [ "Iobenguane" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/006/002", "product_name": "Sodium Iodide (I131) Capsule T 37-7400 MBq hard capsule", "holder": "Curium Netherlands B.V.", "authorised_date": "2001-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "V10XA", "V10XA01" ], "active_substances": [ "Sodium iodide (131I)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/007/001", "product_name": "KryptoScan, [81m Kr] Radionuclide generator", "holder": "Curium Netherlands B.V.", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Radionuclide generator", "atc_codes": [ "V09EX01" ], "active_substances": [ "Krypton (81m kr)" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/008/001", "product_name": "Indium (In111) Chloride 370MBq/ml radiopharmaceutical precursor", "holder": "Curium Netherlands B.V.", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Radiopharmaceutical precursor, solution", "atc_codes": [ "V09AX01" ], "active_substances": [ "Indium (111 in)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/009/001", "product_name": "Indium (111In) DTPA 37MBq/ml Solution for Injection", "holder": "Curium Netherlands B.V.", "authorised_date": "2004-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09AX01" ], "active_substances": [ "Indium (111 in)", "PENTETIC ACID" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/010/001", "product_name": "Technescan PYP 20 mg kit for radiopharmaceutical preparation", "holder": "Curium Netherlands B.V.", "authorised_date": "2001-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09GA", "V09GA06" ], "active_substances": [ "Sodium pyrophosphate decahydrate", "Stannous chloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/011/001", "product_name": "Technescan DMSA 1.2 mg kit for radiopharmaceutical preparation", "holder": "Curium Netherlands B.V.", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09CA", "V09CA02" ], "active_substances": [ "Succimer" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/015/001", "product_name": "TechneScan DTPA 20.8 mg kit for radiopharmaceutical preparation", "holder": "Curium Netherlands B.V.", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09CA01", "V09EA01" ], "active_substances": [ "PENTETIC ACID" ], "routes": [ "Inhalation use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/016/001", "product_name": "Thallous (Tl201) chloride injection 37 MBq/ml solution for injection", "holder": "Curium Netherlands B.V.", "authorised_date": "1981-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09GX", "V09GX01" ], "active_substances": [ "Thallous chloride (201 tl)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/017/001", "product_name": "Ultra-TechneKow FM 2.15-43.00 GBq radionuclide generator", "holder": "Curium Netherlands B.V.", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Radionuclide generator", "atc_codes": [ "V09FX", "V09FX01" ], "active_substances": [ "Sodium molybdate (99mo)" ], "routes": [ "Intravenous use", "Ocular use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/018/001", "product_name": "TechneScan MAG3, powder for solution for injection", "holder": "Curium Netherlands B.V.", "authorised_date": "1992-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "V09CA", "V09CA03" ], "active_substances": [ "Betiatide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0690/020/001", "product_name": "Technescan MIBI 1mg kit for radiopharmaceutical preparation", "holder": "Curium Netherlands B.V.", "authorised_date": "2008-11-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09GA01" ], "active_substances": [ "Tetrakis (2-methylopropyl-isocyanide) copper (i) tetrafluoroborate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0697/002/001", "product_name": "Dipeptiven, concentrate for solution for infusion", "holder": "Fresenius AG", "authorised_date": "1996-05-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XB", "B05XB02" ], "active_substances": [ "L-alanyl-l glutamine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/003/001", "product_name": "Atecor 25mg Tablets", "holder": "Rowex Limited,", "authorised_date": "1989-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB03" ], "active_substances": [ "Atenolol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/003/002", "product_name": "Atecor 50mg Tablets", "holder": "Rowex Limited,", "authorised_date": "1989-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB03" ], "active_substances": [ "Atenolol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/003/003", "product_name": "Atecor 100mg Tablets", "holder": "Rowex Limited,", "authorised_date": "1991-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB03" ], "active_substances": [ "Atenolol" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/008/001", "product_name": "Metocor 50 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "1995-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB02" ], "active_substances": [ "METOPROLOL TARTRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/008/002", "product_name": "Metocor 100 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "1995-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB02" ], "active_substances": [ "METOPROLOL TARTRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/002", "product_name": "Diclac 1% w/w Gel", "holder": "Rowex Limited,", "authorised_date": "1999-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/003", "product_name": "Diclac 75 mg Prolonged-release Tablet", "holder": "Rowex Limited,", "authorised_date": "1999-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/005", "product_name": "Diclac Relief 1% w/w Gel", "holder": "Rowex Limited,", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/006", "product_name": "Diclac Retard 100 mg Prolonged-release Tablets", "holder": "Rowex Limited,", "authorised_date": "1992-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/008", "product_name": "Diclac 50 mg Gastro-resistant Tablets", "holder": "Rowex Limited,", "authorised_date": "1992-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/009", "product_name": "Diclac 100mg Suppositories", "holder": "Rowex Limited,", "authorised_date": "1992-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/009/010", "product_name": "Diclac 25 mg/ml Solution for Injection 3 ml Ampoule", "holder": "Rowex Limited,", "authorised_date": "1992-08-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/016/004", "product_name": "Verap 120mg Prolonged Release Tablets", "holder": "Rowex Limited,", "authorised_date": "2001-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08DA", "C08DA01" ], "active_substances": [ "Verapamil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/016/005", "product_name": "Verap 240mg prolonged release tablets", "holder": "Rowex Limited,", "authorised_date": "2001-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08DA", "C08DA01" ], "active_substances": [ "Verapamil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/017/001", "product_name": "Acic 5% Cream", "holder": "Rowex Ltd", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB03" ], "active_substances": [ "Aciclovir" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/017/006", "product_name": "Acic Cold Sore 5% w/w Cream", "holder": "Rowex Ltd", "authorised_date": "2012-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB03" ], "active_substances": [ "Aciclovir" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/020/001", "product_name": "Atecor CT 50 mg/12.5 mg Film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "1999-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07CB", "C07CB03" ], "active_substances": [ "Chlortalidone", "Atenolol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/020/002", "product_name": "Atecor CT 100 mg/25 mg Film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "1999-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07CB", "C07CB03" ], "active_substances": [ "Chlortalidone", "Atenolol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/022/001", "product_name": "Tamox 10 mg Film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "1992-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BA", "L02BA01" ], "active_substances": [ "Tamoxifen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/022/002", "product_name": "Tamox 20 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "1992-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BA", "L02BA01" ], "active_substances": [ "Tamoxifen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/028/001", "product_name": "ENAP 5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "1999-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/028/002", "product_name": "ENAP 10 mg tablets", "holder": "Rowex Limited,", "authorised_date": "1999-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/028/003", "product_name": "ENAP 20 mg tablets", "holder": "Rowex Limited,", "authorised_date": "1999-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/029/001", "product_name": "Tradol 50mg Hard Capsules", "holder": "Rowex Limited,", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/029/003", "product_name": "Tradol 50mg/ml Solution for Injection or Infusion", "holder": "Rowex Limited,", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/029/005", "product_name": "Tradol SR 100 mg Prolonged release tablets", "holder": "Rowex Limited,", "authorised_date": "2005-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/029/006", "product_name": "Tradol SR 150 mg Prolonged release tablets", "holder": "Rowex Limited,", "authorised_date": "2005-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/029/007", "product_name": "Tradol SR 200 mg Prolonged release tablets", "holder": "Rowex Limited,", "authorised_date": "2005-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/039/001", "product_name": "Zolnod 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/046/001", "product_name": "Domerid 10mg tablets", "holder": "Rowex Limited,", "authorised_date": "2003-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/046/002", "product_name": "Domerid Relief 10mg tablets", "holder": "Rowex Limited,", "authorised_date": "2003-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/047/002", "product_name": "Lispril 5 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/047/003", "product_name": "Lispril 10 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril (as dihydrate)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/047/004", "product_name": "Lispril 20 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril (as dihydrate)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/050/001", "product_name": "Sivatin 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2002-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/050/002", "product_name": "Sivatin 20 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2002-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/050/003", "product_name": "Sivatin 40 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2002-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/051/001", "product_name": "Lispril-Hydrochlorothiazide 10 mg/12.5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2004-01-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA", "C09BA03" ], "active_substances": [ "Lisinopril Dihydrate", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/051/002", "product_name": "Lispril-Hydrochlorothiazide 20 mg/12.5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2004-01-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA", "C09BA03" ], "active_substances": [ "Lisinopril Dihydrate", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/052/001", "product_name": "Parox 20mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2002-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB05" ], "active_substances": [ "Paroxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/052/003", "product_name": "Parox 10mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2007-01-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB05" ], "active_substances": [ "Paroxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/052/004", "product_name": "Parox 30 mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2007-01-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB05" ], "active_substances": [ "Paroxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/057/001", "product_name": "Flucol 50 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/057/003", "product_name": "Flucol 150 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/057/004", "product_name": "Flucol 200 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/058/001", "product_name": "Pravitin 10 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/058/002", "product_name": "Pravitin 20 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/058/004", "product_name": "Pravitin 40 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/061/001", "product_name": "Clorom 250 mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/061/002", "product_name": "Clorom 500 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2004-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/062/001", "product_name": "Mirap 15 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2004-08-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/062/002", "product_name": "Mirap 30 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2004-08-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/062/003", "product_name": "Mirap 45 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2004-08-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/063/001", "product_name": "Ramilo 1.25 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/063/002", "product_name": "Ramilo 2.5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/063/003", "product_name": "Ramilo 5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/063/004", "product_name": "Ramilo 10 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/064/001", "product_name": "Citrol 10 mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/064/002", "product_name": "CITROL 20 mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/064/003", "product_name": "Citrol 30 mg Film-Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/065/001", "product_name": "Serlan 50 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2005-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/065/002", "product_name": "Serlan 100 mg Film-Coated Tablet", "holder": "Rowex Limited,", "authorised_date": "2005-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/067/001", "product_name": "Lanzol 15 mg hard gastro-resistant capsules", "holder": "Rowex Ltd", "authorised_date": "2005-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/067/002", "product_name": "Lanzol 30 mg hard gastro-resistant capsules", "holder": "Rowex Ltd", "authorised_date": "2005-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/075/001", "product_name": "Cetrine 10 mg Film-coated Tablets", "holder": "Rowex Ltd", "authorised_date": "2004-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/075/002", "product_name": "Cetrine Allergy 10mg Film-coated Tablets", "holder": "Rowex Ltd", "authorised_date": "2004-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/075/003", "product_name": "Cetrine Allergy 1 mg/ml oral solution", "holder": "Rowex Ltd", "authorised_date": "2019-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/079/001", "product_name": "TAMSU 400 micrograms 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"supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/081/002", "product_name": "SUMATRAN 100 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2006-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/085/002", "product_name": "Larig 25 mg Dispersible Tablets", "holder": "Rowex Limited,", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/085/003", "product_name": "Larig 50 mg Dispersible Tablets", "holder": "Rowex Limited,", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/085/004", "product_name": "Larig 100 mg Dispersible Tablets", "holder": "Rowex Limited,", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/085/005", "product_name": "Larig 200 mg Dispersible Tablets", "holder": "Rowex Limited,", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/088/001", "product_name": "Lorat 10mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2005-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/094/001", "product_name": "Mirap DisTab 15 mg orodispersible tablets", "holder": "Rowex Limited,", "authorised_date": "2007-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/094/002", "product_name": "Mirap DisTab 30 mg orodispersible tablets", "holder": "Rowex Limited,", "authorised_date": "2007-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/094/003", "product_name": "Mirap DisTab 45 mg orodispersible tablets", "holder": "Rowex Limited,", "authorised_date": "2007-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/100/001", "product_name": "Biluta 50 mg film-coated tablets", "holder": "Rowex Ltd", "authorised_date": "2007-04-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/101/002", "product_name": "Ceftal 250mg coated tablets", "holder": "Rowex Limited,", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime Axetil Crystalline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/101/003", "product_name": "Ceftal 500 mg Coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime Axetil Crystalline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/103/001", "product_name": "Doxane XL 4 mg prolonged-release tablets", "holder": "Rowex Ltd", "authorised_date": "2007-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/106/001", "product_name": "Rispone 1 mg/ml oral solution", "holder": "Rowex Limited,", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/106/002", "product_name": "Rispone 0.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2007-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/106/006", "product_name": "Rispone 1 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/106/007", "product_name": "Rispone 2 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/106/008", "product_name": "Rispone 3 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/110/001", "product_name": "Fluzac 20mg Capsules", "holder": "Rowex Limited,", "authorised_date": "2006-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB", "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/113/002", "product_name": "Piperin 4 g/0.5 g Powder for Solution for Infusion", "holder": "Rowex Limited,", "authorised_date": "2008-10-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/118/001", "product_name": "Pendrex 2mg tablets", "holder": "Rowex Ltd", "authorised_date": "2008-02-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tert-butylamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/118/002", "product_name": "Pendrex 4mg tablets", "holder": "Rowex Ltd", "authorised_date": "2008-02-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tert-butylamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/118/004", "product_name": "Pendrex 8 mg tablets", "holder": "Rowex Ltd", "authorised_date": "2008-02-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tert-butylamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/120/001", "product_name": "Nebol 5 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2008-01-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB12" ], "active_substances": [ "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/122/001", "product_name": "Cifox 250 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2006-09-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/122/002", "product_name": "Cifox 500 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2006-09-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/122/003", "product_name": "Cifox 750 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2006-09-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/124/001", "product_name": "Rolyprexa 2.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-05-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/124/002", "product_name": "Rolyprexa 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-05-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/124/003", "product_name": "Rolyprexa 7.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-05-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/138/001", "product_name": "Amlode 5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/140/002", "product_name": "Alprazolam 0.5 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2008-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/141/001", "product_name": "Dozept 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-10-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", 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"Pantup Relief 20 mg Gastro-resistant tablets", "holder": "Rowex Limited,", "authorised_date": "2011-03-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/143/001", "product_name": "Dancex SR 5 mg Prolonged-Release Tablets", "holder": "Rowex Limited,", "authorised_date": "2008-08-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/143/004", "product_name": "Dancex SR 40 mg Prolonged-Release Tablets", "holder": "Rowex Limited,", "authorised_date": "2012-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 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transdermal patch", "holder": "Rowex Limited,", "authorised_date": "2007-04-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/146/004", "product_name": "Fental Matrix 100 micrograms/hour transdermal patch", "holder": "Rowex Limited,", "authorised_date": "2007-04-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/154/001", "product_name": "Alopur 100 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/154/002", "product_name": "Alopur 300 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], 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"authorised_date": "2009-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/156/004", "product_name": "Quetex 200 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2009-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/156/005", "product_name": "Quetex 300 mg film-coated tablets", "holder": "Rowex Ltd", "authorised_date": "2009-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/158/001", "product_name": "Emazole 20 mg gastro-resistant tablets", "holder": "Rowex Limited,", "authorised_date": "2009-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/158/002", "product_name": "Emazole 40 mg gastro-resistant tablets", "holder": "Rowex Limited,", "authorised_date": "2009-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole magnesium dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/159/001", "product_name": "Bisop 1.25 mg film-coated tablets", "holder": "Rowex 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only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/159/003", "product_name": "Bisop 3.75 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/159/004", "product_name": "Bisop 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/159/005", "product_name": "Bisop 7.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/159/006", "product_name": "Bisop 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2008-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/161/002", "product_name": "Vedixal 37.5mg Tablets", "holder": "Rowex Ltd", "authorised_date": "2006-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"Tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/170/002", "product_name": "Sidena 50 mg Tablets", "holder": "Rowex Limited,", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/170/003", "product_name": "Sidena 100 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/171/001", "product_name": "Pendrex Plus 4mg/1.25mg tablets", "holder": "Rowex Limited,", "authorised_date": "2010-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA", "C09BA04" ], "active_substances": [ "Indapamide", "Perindopril tert-butylamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", 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"authorised_date": "2010-06-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/176/004", "product_name": "Rosuva 40 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2010-06-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": 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"2010-09-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/182/001", "product_name": "Co-Vatan 80 mg/12.5 mg Film-coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", 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"C09CA", "C09CA03" ], "active_substances": [ "Valsartan", "Hydrocholothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/183/001", "product_name": "Vatan 40 mg Film-coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2010-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/183/002", "product_name": "Vatan 80 mg Film-coated 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"M05BA07" ], "active_substances": [ "Risedronate sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/190/001", "product_name": "Letzo 2.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2010-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/194/001", "product_name": "Esciprex 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2011-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/194/002", "product_name": "Esciprex 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2011-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/196/001", "product_name": "Mometasone 50 microgram/dose, Nasal spray, Suspension", "holder": "Rowex Ltd", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD09" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/202/001", "product_name": "Deslor 5 mg 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through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/208/001", "product_name": "Freedonel 0.02 mg/3 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Ethinylestradiol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/217/001", "product_name": "Calciup D3 Forte 1000mg/880 IU Chewable Tablets", "holder": "Rowex Limited,", "authorised_date": "2012-02-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/217/002", "product_name": "Calciup D3 500 mg/440 IU chewable tablet", "holder": "Rowex Ltd", "authorised_date": "2014-08-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium carbonate", "Cholecalciferol concentrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/218/001", "product_name": "Freedo 0.03mg/3mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/224/001", "product_name": "Macrolief 13.8g sachet, powder for oral solution", "holder": "Rowex Limited,", "authorised_date": "2013-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/230/001", "product_name": "Linezolid 600 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2014-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/232/001", "product_name": "Etoricoxib 30 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2015-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/232/002", "product_name": "Etoricoxib 60 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2015-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/232/003", "product_name": "Etoricoxib 90 mg film-coated tablets", "holder": "Rowex Ltd", "authorised_date": "2015-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/232/004", "product_name": "Etoricoxib 120 mg film-coated tablets", "holder": "Rowex Ltd", "authorised_date": "2015-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/235/001", "product_name": "Eplerenone Rowex 25 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2011-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/235/002", "product_name": "Eplerenone Rowex 50 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2011-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/236/001", "product_name": "Reletrans 5 micrograms/hour Transdermal Patches", "holder": "Rowex Limited,", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/236/002", "product_name": "Reletrans 10 micrograms/hour Transdermal Patches", "holder": "Rowex Limited,", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/236/003", "product_name": "Reletrans 15 micrograms/hour Transdermal Patches", "holder": "Rowex Limited,", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/236/004", "product_name": "Reletrans 20 micrograms/hour Transdermal Patches", "holder": "Rowex Limited,", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/237/001", "product_name": "AirFluSal Forspiro 50 microgram/250 microgram/dose, inhalation powder, predispensed", "holder": "Rowex Limited,", "authorised_date": "2014-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/237/002", "product_name": "AirFluSal Forspiro 50 microgram/500 microgram/dose, inhalation powder, predispensed", "holder": "Rowex Limited,", "authorised_date": "2014-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/243/001", "product_name": "Desogestrel Rowex 75 microgram Film-coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2015-10-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AC", "G03AC09" ], "active_substances": [ "Desogestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/245/001", "product_name": "Fulvestrant Rowex 250 mg/5 ml solution for injection in pre-filled syringe", "holder": "Rowex Limited,", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L02BA", "L02BA03" ], "active_substances": [ "Fulvestrant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/248/001", "product_name": "Imatinib Rowex 100 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2015-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE01" ], "active_substances": [ "Imatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/248/002", "product_name": "Imatinib Rowex 400 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2015-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE01" ], "active_substances": [ "Imatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/250/001", "product_name": "Dancex SR Plus 5 mg/2.5 mg Prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/250/002", "product_name": "Dancex SR Plus 10 mg/5 mg Prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/250/003", "product_name": "Dancex SR Plus 20 mg/10 mg Prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/250/004", "product_name": "Dancex SR Plus 40 mg/20 mg Prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/254/001", "product_name": "Calcipotriol/Betamethasone Rowex 50 microgram/g + 0.5 mg/g Ointment", "holder": "Rowex Limited,", "authorised_date": "2016-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D05AX", "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/255/001", "product_name": "Olmesartan Rowex 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/255/002", "product_name": "Olmesartan Rowex 20 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/255/003", "product_name": "Olmesartan Rowex 40 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/258/001", "product_name": "Quetex XR 50 mg prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/258/002", "product_name": "Quetex XR 200 mg prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/258/003", "product_name": "Quetex XR 300 mg prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/258/004", "product_name": "Quetex XR 400 mg prolonged-release tablets", "holder": "Rowex Limited,", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/264/001", "product_name": "Rasagiline Rowex 1 mg tablets", "holder": "Rowex Limited,", "authorised_date": "2015-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Rasagiline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/265/001", "product_name": "Ivabradine Rowex 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2016-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/265/002", "product_name": "Ivabradine Rowex 7.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2016-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/266/001", "product_name": "Silcarfil 20 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2016-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/267/001", "product_name": "Levonorgestrel Rowex 1.5mg Tablet", "holder": "Rowex Limited,", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AD", "G03AD01" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/269/004", "product_name": "Darunavir Rowex 800 mg Film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AE", "J05AE10" ], "active_substances": [ "Darunavir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/270/001", "product_name": "AirFluSal MDI 25 microgram/125 microgram/dose pressurised inhalation, suspension", "holder": "Rowex Limited,", "authorised_date": "2017-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/270/002", "product_name": "AirFluSal MDI 25 microgram/250 microgram/dose pressurised inhalation, suspension", "holder": "Rowex Limited,", "authorised_date": "2017-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/272/001", "product_name": "Sumatran Relief 50mg tablets", "holder": "Rowex Limited,", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/273/001", "product_name": "Febuxostat Rowex 80 mg Film-coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/273/002", "product_name": "Febuxostat Rowex 120 mg Film-coated Tablets", "holder": "Rowex Limited,", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M04AA", "M04AA03" ], "active_substances": [ "Febuxostat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/274/001", "product_name": "Entecavir Rowex 0.5 mg Film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF", "J05AF10" ], "active_substances": [ "ENTECAVIR MONOHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/275/001", "product_name": "Rivaroxaban Rowex 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/275/002", "product_name": "Rivaroxaban Rowex 15 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/275/003", "product_name": "Rivaroxaban Rowex 20 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF", "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/278/001", "product_name": "Anidulafungin 100 mg Powder for concentrate for solution for infusion", "holder": "Rowex Limited,", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX06" ], "active_substances": [ "Anidulafungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/279/001", "product_name": "Rhinex Relief 50 micrograms/actuation Nasal spray, suspension", "holder": "Rowex Limited,", "authorised_date": "2018-07-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD09" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/280/001", "product_name": "Solifenacin succinate Rowex 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/280/002", "product_name": "Solifenacin succinate Rowex 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/284/001", "product_name": "AirBuFo Forspiro 160 microgram/4.5 microgram/dose inhalation powder, pre-dispensed", "holder": "Rowex Limited,", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/284/002", "product_name": "AirBuFo Forspiro 320 microgram/9 microgram/dose inhalation powder, pre-dispensed", "holder": "Rowex Limited,", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/286/001", "product_name": "Oxycodone hydrochloride Rowex 5 mg Hard capsules", "holder": "Rowex Ltd", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/286/002", "product_name": "Oxycodone hydrochloride Rowex 10 mg Hard capsules", "holder": "Rowex Ltd", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/286/003", "product_name": "Oxycodone hydrochloride Rowex 20 mg Hard capsules", "holder": "Rowex Ltd", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/287/004", "product_name": "Atazanavir Rowex 300 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2019-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J05AE08" ], "active_substances": [ "Atazanavir sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/288/001", "product_name": "Bortezomib Rowex 3.5 mg Powder for solution for injection", "holder": "Rowex Limited,", "authorised_date": "2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XG01" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/289/001", "product_name": "Sunitinib Rowex 12.5 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE04" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/289/002", "product_name": "Sunitinib Rowex 25 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE04" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/289/003", "product_name": "Sunitinib Rowex 50 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XE", "L01XE04" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/292/001", "product_name": "Ulipristal Acetate Rowex 30 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AD", "G03AD02" ], "active_substances": [ "Ulipristal acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/297/001", "product_name": "Azacitidine Rowex 25 mg/ml Powder for suspension for injection", "holder": "Rowex Limited,", "authorised_date": "2020-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/299/001", "product_name": "Ticagrelor Rowex 90 mg Film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2021-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/001", "product_name": "Lenalidomide Rowex 2.5 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/002", "product_name": "Lenalidomide Rowex 5 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/003", "product_name": "Lenalidomide Rowex 7.5 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/004", "product_name": "Lenalidomide Rowex 10 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/005", "product_name": "Lenalidomide Rowex 15 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/006", "product_name": "Lenalidomide Rowex 20 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/302/007", "product_name": "Lenalidomide Rowex 25 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/303/001", "product_name": "Apixaban Rowex 2.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2021-09-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/303/002", "product_name": "Apixaban Rowex 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2021-09-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/304/002", "product_name": "Abiraterone 500 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2021-06-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/310/002", "product_name": "Benzylpenicillin sodium 3000 mg Powder for Solution for Injection/Infusion", "holder": "Rowex Ltd", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/312/002", "product_name": "Isotretinoin 10 mg soft capsules", "holder": "Rowex Limited,", "authorised_date": "2020-06-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/312/003", "product_name": "Isotretinoin 20 mg soft capsules", "holder": "Rowex Limited,", "authorised_date": "2020-06-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/315/001", "product_name": "Ferric carboxymaltose 50 mg iron/ml dispersion for injection/infusion", "holder": "Rowex Limited,", "authorised_date": "2022-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersion for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "Ferric carboxymaltose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/317/001", "product_name": "Solifenacin succinate/Tamsulosin hydrochloride Rowex 6 mg/0.4 mg modified-release tablets", "holder": "Rowex Limited,", "authorised_date": "2023-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "G04CA53" ], "active_substances": [ "Solifenacin succinate", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/319/001", "product_name": "Alendronic acid/Colecalciferol Rowex 70 mg/2 800 IU tablets", "holder": "Rowex Limited,", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BB03" ], "active_substances": [ "Alendronate sodium trihydrate", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/319/002", "product_name": "Alendronic acid/Colecalciferol Rowex 70 mg/5 600 IU tablets", "holder": "Rowex Limited,", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BB03" ], "active_substances": [ "Alendronate sodium trihydrate", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/322/001", "product_name": "Dimethyl fumarate Rowex 240 mg gastro-resistant hard capsules", "holder": "Rowex Limited,", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/323/001", "product_name": "Bosutinib Rowex 100 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA04" ], "active_substances": [ "Bosutinib dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/323/002", "product_name": "Bosutinib Rowex 400 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA04" ], "active_substances": [ "Bosutinib dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/323/003", "product_name": "Bosutinib Rowex 500 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA04" ], "active_substances": [ "Bosutinib dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/324/001", "product_name": "Azelastine hydrochloride /Fluticasone propionate Rowex 137 micrograms/50 micrograms per actuation, nasal spray suspension", "holder": "Rowex Limited,", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD58" ], "active_substances": [ "Azelastine hydrochloride", "Fluticasone propionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/325/001", "product_name": "Naproxen/Esomeprazole Rowex Ltd 500 mg/20 mg modified-release tablets", "holder": "Rowex Limited,", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AE52" ], "active_substances": [ "Naproxen", "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/326/001", "product_name": "Naproxen/Esomeprazole Rowex 500 mg/20 mg modified-release tablets", "holder": "Rowex Limited,", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AE52" ], "active_substances": [ "Naproxen", "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/327/001", "product_name": "Zofran 4mg/2ml Solution for Injection or Infusion", "holder": "Rowex Limited,", "authorised_date": "1990-06-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron hydrochloride dihydrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/327/002", "product_name": "Zofran 4 mg/5 ml syrup", "holder": "Rowex Ltd", "authorised_date": "1998-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/327/003", "product_name": "Zofran 4 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "1990-06-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/327/004", "product_name": "Zofran 8 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "1990-06-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/327/005", "product_name": "Zofran Zydis 4 mg oral lyophilisate", "holder": "Rowex Limited,", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/327/006", "product_name": "Zofran Zydis 8 mg oral lyophilisate", "holder": "Rowex Limited,", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/328/001", "product_name": "Dimethyl fumarate Rowex 120 mg hard gastro-resistant capsules", "holder": "Rowex Limited,", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/328/002", "product_name": "Dimethyl fumarate Rowex 240 mg hard gastro-resistant capsules", "holder": "Rowex Limited,", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/330/001", "product_name": "Apremilast Rowex 30 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/330/002", "product_name": "Apremilast Rowex 10 mg film-coated tablets Apremilast Rowex 20 mg film-coated tablets Apremilast Rowex 30 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/331/001", "product_name": "Diclac Relief Max 2% w/w gel", "holder": "Rowex Limited,", "authorised_date": "2025-05-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac Diethylamine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/332/001", "product_name": "Enzalutamide Rowex 40 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2023-11-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/332/002", "product_name": "Enzalutamide Rowex 80 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2023-11-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/333/001", "product_name": "Linagliptin Rowex 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2024-11-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH05" ], "active_substances": [ "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/334/001", "product_name": "Enzalutamide Rowex 40 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/334/002", "product_name": "Enzalutamide Rowex 80 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/335/001", "product_name": "Linagliptin/Metformin hydrochloride 2.5 mg/ 850 mg", "holder": "Rowex Limited,", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD11" ], "active_substances": [ "Linagliptin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/335/002", "product_name": "Linagliptin/Metformin hydrochloride 2.5 mg/1000 mg", "holder": "Rowex Limited,", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD11" ], "active_substances": [ "Linagliptin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/336/001", "product_name": "Zonisamide Rowex 25 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2024-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/336/002", "product_name": "Zonisamide Rowex 50 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2024-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/336/003", "product_name": "Zonisamide Rowex 100 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2024-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/337/001", "product_name": "Edoxaban Rowex 15 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/337/002", "product_name": "Edoxaban Rowex 30 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated 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Rowex 2 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/338/003", "product_name": "Pomalidomide Rowex 3 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/340/001", "product_name": "Macitentan Rowex 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/341/001", "product_name": "Pazopanib Rowex 200 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX03" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/341/002", "product_name": "Pazopanib Rowex 400 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX03" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/342/001", "product_name": "Dapagliflozin Rowex 5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/342/002", "product_name": "Dapagliflozin Rowex 10 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/343/001", "product_name": "Brinzolamide Rowex 10 mg/ml eye drops, suspension", "holder": "Rowex Limited,", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01EC04" ], "active_substances": [ "Brinzolamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/344/001", "product_name": "Imatinib Rowex 100 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA01" ], "active_substances": [ "Imatinib mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/344/002", "product_name": "Imatinib Rowex 400 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EA01" ], "active_substances": [ "Imatinib mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/345/001", "product_name": "Eltrombopag Rowex 12.5 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/345/002", "product_name": "Eltrombopag Rowex 25 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/345/003", "product_name": "Eltrombopag Rowex 50 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/345/004", "product_name": "Eltrombopag Rowex 75 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/346/001", "product_name": "Fingolimod Rowex 0.5 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "FINGOLIMOD HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/352/001", "product_name": "Lisdexamfetamine dimesylate Rowex 20 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/352/002", "product_name": "Lisdexamfetamine dimesylate Rowex 30 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/352/003", "product_name": "Lisdexamfetamine dimesylate Rowex 40 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/352/004", "product_name": "Lisdexamfetamine dimesylate Rowex 50 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/352/005", "product_name": "Lisdexamfetamine dimesylate Rowex 60 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/352/006", "product_name": "Lisdexamfetamine dimesylate Rowex 70 mg hard capsules", "holder": "Rowex Limited,", "authorised_date": "2026-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/001", "product_name": "Levothyroxine sodium Rowex 25 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/002", "product_name": "Levothyroxine sodium Rowex 50 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/003", "product_name": "Levothyroxine sodium Rowex 75 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/004", "product_name": "Levothyroxine sodium Rowex 100 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/005", "product_name": "Levothyroxine sodium Rowex 125 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/006", "product_name": "Levothyroxine sodium Rowex 150 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/354/007", "product_name": "Levothyroxine sodium Rowex 200 microgram tablets", "holder": "Rowex Limited,", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/355/001", "product_name": "Emazole Control 20 mg gastro-resistant tablets", "holder": "Rowex Limited,", "authorised_date": "2019-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole magnesium dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/358/001", "product_name": "Naropin 7.5 mg/ml solution for injection", "holder": "Rowex Limited,", "authorised_date": "1996-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB09" ], "active_substances": [ "Ropivacaine Hydrochloride" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/360/001", "product_name": "Pirfenidone Rowex 267 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/360/002", "product_name": "Pirfenidone Rowex 801 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/363/001", "product_name": "Sitagliptin Rowex 25 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/363/002", "product_name": "Sitagliptin Rowex 50 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0711/363/003", "product_name": "Sitagliptin Rowex 100 mg film-coated tablets", "holder": "Rowex Limited,", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/001", "product_name": "Omnipaque 140 mg I/ml Solution for Injection (Glass)", "holder": "GE Healthcare AS", "authorised_date": "1999-07-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/002", "product_name": "Omnipaque 180 mg I/ml Solution for Injection (Glass)", "holder": "GE Healthcare AS", "authorised_date": "1990-03-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/004", "product_name": "Omnipaque 240 mg I/ml Solution for Injection (Glass)", "holder": "GE Healthcare AS", "authorised_date": "1990-03-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/008", "product_name": "Omnipaque 300 mg I/ml Solution for Injection (Glass)", "holder": "GE Healthcare AS", "authorised_date": "1990-03-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/013", "product_name": "Omnipaque 350 mg I/ml Solution for Injection (Glass)", "holder": "GE Healthcare AS", "authorised_date": "1990-03-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/018", "product_name": "Omnipaque 300 mg I/ml Solution for Injection (Polypropylene)", "holder": "GE Healthcare AS", "authorised_date": "1993-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/020", "product_name": "Omnipaque 350 mg I/ml Solution for Injection (Polypropylene)", "holder": "GE Healthcare AS", "authorised_date": "1993-11-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/006/023", "product_name": "Omnipaque 240 mg I/ml Solution for Injection (Polypropylene)", "holder": "GE Healthcare AS", "authorised_date": "2000-03-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB02" ], "active_substances": [ "Iohexol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/009/003", "product_name": "VISIPAQUE 270 mg I/ml Solution for Injection, glass container", "holder": "GE Healthcare AS", "authorised_date": "1995-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB09" ], "active_substances": [ "Iodixanol" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/009/007", "product_name": "VISIPAQUE 320 mg I/ml Solution for Injection, glass container", "holder": "GE Healthcare AS", "authorised_date": "1995-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB09" ], "active_substances": [ "Iodixanol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/009/012", "product_name": "VISIPAQUE 270 mg I/ml Solution for Injection, polypropylene container", "holder": "GE Healthcare AS", "authorised_date": "1995-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB09" ], "active_substances": [ "Iodixanol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/009/013", "product_name": "Visipaque 320 mg I/ml Solution for Injection, polypropylene container", "holder": "GE Healthcare AS", "authorised_date": "1995-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB09" ], "active_substances": [ "Iodixanol" ], "routes": [ "Intraarterial use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/011/001", "product_name": "Clariscan 279.32 mg/ml solution for injection", "holder": "GE Healthcare AS", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA02" ], "active_substances": [ "Gadoteric acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/011/002", "product_name": "Clariscan 279.32 mg/ml solution for injection in pre-filled syringe", "holder": "GE Healthcare AS", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V08CA", "V08CA02" ], "active_substances": [ "Gadoteric acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0735/012/001", "product_name": "MYOVIEW 230 micrograms kit for radiopharmaceutical preparation", "holder": "GE Healthcare AS", "authorised_date": "2001-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09GA", "V09GA02" ], "active_substances": [ "Tetrofosmin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/002/001", "product_name": "Metronidazole 5 mg/ml solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2001-06-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01XD", "J01XD01" ], "active_substances": [ "Metronidazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/003/001", "product_name": "Sodium Chloride 0.9% w/v Intravenous Infusion BP Solution for Infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1998-02-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/003/002", "product_name": "Sodium Chloride Intravenous Infusion BP 0.9% w/v Solution for Infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/003/003", "product_name": "0.9 % w/v Sodium Chloride Injection BP", "holder": "B. Braun Melsungen AG", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V07AB" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/005/001", "product_name": "Nutriflex basal solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine Monoglutamate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Magnesium acetate tetrahydrate", "Sodium acetate trihydrate", "Potassium dihydrogen phosphate", "Potassium hydroxide", "Sodium hydroxide", "Glucose monohydrate", "Calcium chloride dihydrate", "Sodium chloride", "Histidine hydrochloride monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/006/001", "product_name": "Nutriflex peri solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine Monoglutamate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Magnesium acetate tetrahydrate", "Sodium acetate trihydrate", "Potassium dihydrogen phosphate", "Potassium hydroxide", "Sodium hydroxide", "Glucose monohydrate", "Calcium chloride dihydrate", "Sodium chloride", "Histidine hydrochloride monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/007/001", "product_name": "Nutriflex plus solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine Monoglutamate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Magnesium acetate tetrahydrate", "Sodium acetate trihydrate", "Sodium dihydrogen phosphate dihydrate", "Potassium hydroxide", "Sodium hydroxide", "Glucose monohydrate", "Calcium chloride dihydrate", "Histidine hydrochloride monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/008/001", "product_name": "Nutriflex special solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "V06DE" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine Monoglutamate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Magnesium acetate tetrahydrate", "Sodium acetate trihydrate", "Potassium dihydrogen phosphate", "Potassium hydroxide", "Sodium hydroxide", "Glucose monohydrate", "Calcium chloride dihydrate", "Histidine hydrochloride monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/011/001", "product_name": "Gelofusine 40mg/ml Solution for Infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-03-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA06" ], "active_substances": [ "Succinylated gelatine (= modified fluid gelatine)", "Sodium chloride", "Sodium hydroxide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/018/001", "product_name": "Propofol-Lipuro 1% (10 mg/ml) emulsion for injection or infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-05-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/018/002", "product_name": "Propofol-Lipuro 1% (10 mg/ml) emulsion for injection or infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2000-05-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/018/003", "product_name": "Propofol-Lipuro 2% (20 mg/ml) emulsion for injection or infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2004-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/029/001", "product_name": "Rocuronium 10 mg/ml solution for injection/infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2008-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/030/001", "product_name": "Fluconazole 2 mg/ml solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2008-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/033/002", "product_name": "Omeflex peri emulsion for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2017-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine hydrochloride monohydrate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Sodium hydroxide", "Sodium chloride", "Sodium acetate trihydrate", "Potassium acetate", "Magnesium acetate tetrahydrate", "Calcium chloride dihydrate", "Glucose monohydrate", "Sodium dihydrogen phosphate dihydrate", "Zinc acetate dihydrate", "Triglycerides, medium chain", "Soya bean oil, refined", "Omega-3-acid triglycerides" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/034/001", "product_name": "Gelaspan Solution for Infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2011-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA06" ], "active_substances": [ "Succinylated gelatine (= modified fluid gelatine)", "Sodium chloride", "Sodium acetate trihydrate", "Potassium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/035/001", "product_name": "Paracetamol 10mg/ml solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2012-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/038/001", "product_name": "Omeflex special without electrolytes emulsion for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine monohydrate", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Glucose monohydrate", "Triglycerides, medium chain", "SOYA BEAN OIL, REFINED PH. EUR.", "Omega-3-acid triglycerides" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/039/001", "product_name": "Omeflex plus emulsion for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine hydrochloride monohydrate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Potassium acetate", "Magnesium acetate tetrahydrate", "Calcium chloride dihydrate", "Sodium chloride", "Sodium dihydrogen phosphate dihydrate", "Triglycerides, medium chain", "Sodium hydroxide", "Sodium acetate trihydrate", "Glucose monohydrate", "Zinc acetate dihydrate", "Soya bean oil, refined", "Omega-3-acid triglycerides" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/040/001", "product_name": "Omeflex special emulsion for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine hydrochloride monohydrate", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Proline", "Serine", "Sodium hydroxide", "Sodium chloride", "Sodium acetate trihydrate", "Potassium acetate", "Magnesium acetate tetrahydrate", "Calcium chloride dihydrate", "Glucose monohydrate", "Sodium dihydrogen phosphate dihydrate", "Zinc acetate dihydrate", "Triglycerides, medium chain", "Soya bean oil, refined", "Omega-3-acid triglycerides" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/041/001", "product_name": "Ibuprofen B. Braun 400 mg solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/041/002", "product_name": "Ibuprofen B. Braun 600 mg solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/041/003", "product_name": "Ibuprofen B. Braun 200 mg solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2020-05-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/042/001", "product_name": "Dexmedetomidine B. Braun 100 micrograms/ml concentrate for solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "2020-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N05CM18" ], "active_substances": [ "Dexmedetomidine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/044/001", "product_name": "1% w/v Lidocaine Hydrochloride Injection BP", "holder": "B. Braun Melsungen AG", "authorised_date": "1992-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Intradermal use", "Intramuscular use", "Intravenous use", "Perineural use", "Submucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0736/044/002", "product_name": "2% w/v Lidocaine Hydrochloride Injection BP", "holder": "B. Braun Melsungen AG", "authorised_date": "1992-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Intradermal use", "Intramuscular use", "Intravenous use", "Perineural use", "Submucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0736/045/001", "product_name": "Glucose Intravenous Infusion BP 5% w/v solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05", "B05BA", "B05BA03", "V07AB" ], "active_substances": [ "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/045/002", "product_name": "Glucose Intravenous Infusion BP 10% w/v, solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1992-08-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Anhydrous glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/045/003", "product_name": "Glucose 50% w/v sterile concentrate, concentrate solution for infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1992-08-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Anhydrous glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/046/001", "product_name": "Compound Sodium Lactate Intravenous Infusion BP, Solution for Infusion (Hartmann’s Solution)", "holder": "B. Braun Melsungen AG", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Sodium lactate solution", "Calcium chloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/047/001", "product_name": "Potassium Phosphate 1mmol/ml + 0.6mmol/ml Concentrate for Solution for Infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1993-02-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA06" ], "active_substances": [ "Dipotassium phosphate", "Potassium dihydrogen phosphate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/048/001", "product_name": "8.4% w/v Sodium Bicarbonate Intravenous Infusion BP", "holder": "B. Braun Melsungen AG", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA02" ], "active_substances": [ "Sodium bicarbonate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/049/001", "product_name": "Water for Injections Ph. Eur", "holder": "B. Braun Melsungen AG", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for parenteral use", "atc_codes": [ "V07AB" ], "active_substances": [ "Water for injections" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0736/050/001", "product_name": "Potassium Chloride 15% w/v Concentrate for Solution for Infusion", "holder": "B. Braun Melsungen AG", "authorised_date": "1991-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA01" ], "active_substances": [ "Potassium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0740/003/003", "product_name": "Simvastatin 20 mg film-coated tablets", "holder": "Genthon B.V.", "authorised_date": "2001-10-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0740/003/004", "product_name": "Simvastatin 40 mg film-coated tablets", "holder": "Genthon B.V.", "authorised_date": "2001-10-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0740/007/001", "product_name": "Bisoprololhemifumaraat Genthon 5 mg film-coated tablets", "holder": "Genthon B.V.", "authorised_date": "2002-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0740/007/002", "product_name": "Bisoprololhemifumaraat Genthon 10 mg, film-coated tablets", "holder": "Genthon B.V.", "authorised_date": "2002-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0740/014/001", "product_name": "Sevelamer carbonate Genthon 800 mg, film-coated tablets", "holder": "Genthon B.V.", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE", "V03AE02" ], "active_substances": [ "Sevelamer carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/001/001", "product_name": "Leucovorin-Teva 10mg/ml Concentrate for Solution for Infusion", "holder": "Teva Pharma B.V.", "authorised_date": "2001-05-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "V03AF", "V03AF03" ], "active_substances": [ "Folinic acid" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/002/001", "product_name": "Etoposide-Teva 20 mg/ml Concentrate for Solution for Infusion", "holder": "Teva Pharma B.V.", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CB", "L01CB01" ], "active_substances": [ "Etoposide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/004/001", "product_name": "Carboplatin-Teva 10 mg/ml Concentrate for Solution for Infusion", "holder": "Teva Pharma B.V.", "authorised_date": "2001-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XA", "L01XA02" ], "active_substances": [ "Carboplatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/009/001", "product_name": "Ondansetron 4 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/009/002", "product_name": "Ondansetron 8 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2005-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/011/001", "product_name": "Co-Amoxiclav TEVA 500 mg/100 mg Powder for Solution for Injection/Infusion", "holder": "Teva Pharma B.V.", "authorised_date": "2006-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/011/002", "product_name": "Co-Amoxiclav TEVA 1000 mg/200 mg Powder for Solution for Injection/Infusion", "holder": "Teva Pharma B.V.", "authorised_date": "2006-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/016/001", "product_name": "Tevanate Once Weekly 70mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2006-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronate sodium monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/019/001", "product_name": "Citalopram Teva 10 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-01-19", "product_type": 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/026/001", "product_name": "Losartan/Hydrochlorothiazide Teva 50mg/12.5mg Film-Coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"PA0749/032/001", "product_name": "Bicalutamide Teva 50 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/036/001", "product_name": "Valaciclovir Teva 500 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-05-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB11" ], "active_substances": [ "Valaciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/039/002", "product_name": "Azithromycin Teva 250 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA10" ], "active_substances": [ "Azithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/047/001", "product_name": "Valsartan/Hydrochlorothiazide Teva 80 mg/12.5 mg Film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-07-04", 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"dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/048/002", "product_name": "Montelukast Teva 5 mg Chewable Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/048/003", "product_name": "Montelukast Teva 10 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-06-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/048/004", "product_name": "Montelukast Teva 4 mg GranulesFor children from 6 months to 5 years of age", "holder": "Teva Pharma B.V.", "authorised_date": "2011-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/049/007", "product_name": "Rispeva 1 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/049/008", "product_name": "Rispeva 2 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/049/009", "product_name": "Rispeva 3 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete mixed application" }, { "licence_number": "PA0749/049/010", "product_name": "Rispeva 4 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete mixed application" }, { "licence_number": "PA0749/052/002", "product_name": "Simvastatin Teva 10 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/054/001", "product_name": "Zanaflex 2 mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX02" ], "active_substances": [ "Tizanidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/054/002", "product_name": "Zanaflex 4 mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX02" ], "active_substances": [ "Tizanidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/060/001", "product_name": "Tevaquel 25 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/060/005", "product_name": "Tevaquel 300 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/060/006", "product_name": "Tevaquel XL 50 mg prolonged-release tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/060/007", "product_name": "Tevaquel XL 200 mg Prolonged-release tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/060/008", "product_name": "Tevaquel XL 300 mg Prolonged-release tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/060/009", "product_name": "Tevaquel XL 400 mg Prolonged-release tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/064/001", "product_name": "Risonate Once Weekly 35 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA07" ], "active_substances": [ "Risedronate sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/065/001", "product_name": "Naraverg 2.5 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC02" ], "active_substances": [ "Naratriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/067/001", "product_name": "Amlodipine Teva 5 mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-08-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/067/002", "product_name": "Amlodipine Teva 10 mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-08-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/076/001", "product_name": "Diaglyc 30 mg modified-release tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-08-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "A10BB", "A10BB09" ], "active_substances": [ "Gliclazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/078/001", "product_name": "Nebivolol Teva 5 mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB12" ], "active_substances": [ "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/083/001", "product_name": "Doxorubicin Teva 2 mg/ml Concentrate for Solution for Infusion", "holder": "Teva Pharma B.V.", "authorised_date": "2009-11-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01DB", "L01DB01" ], "active_substances": [ "DOXORUBICIN HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/084/001", "product_name": "Valsartan Teva 40 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/084/002", "product_name": "Valsartan Teva 80 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/084/003", "product_name": "Valsartan Teva 160 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated 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Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-06-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/090/004", "product_name": "Losartan Teva 100 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2008-06-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/095/001", "product_name": "Zolpidem Tartrate Teva 5 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/095/002", "product_name": "Zolpidem Tartrate Teva 10 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF02" ], "active_substances": [ "Zolpidem tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/099/001", "product_name": "Allopurinol Teva 100 mg tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/099/003", "product_name": "Allopurinol Teva 300 mg tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/110/001", "product_name": "Atorvastatin Teva 10 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/110/002", "product_name": "Atorvastatin Teva 20 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/110/003", "product_name": "Atorvastatin Teva 40 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/110/004", "product_name": "Atorvastatin Teva 80 mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/111/001", "product_name": "Escitalopram Teva 5 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/111/002", "product_name": "Escitalopram Teva 10 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/111/003", "product_name": "Escitalopram Teva 15 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/111/004", "product_name": "Escitalopram Teva 20 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/117/001", "product_name": "Tymbrineb 300 mg/5 ml Nebuliser Solution", "holder": "Teva Pharma B.V.", "authorised_date": "2012-11-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "J01GB", "J01GB01" ], "active_substances": [ "Tobramycin" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/143/001", "product_name": "Levothyroxine Teva 25 micrograms Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/143/002", "product_name": "Levothyroxine Teva 50 micrograms Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/143/003", "product_name": "Levothyroxine Teva 100 micrograms Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/144/001", "product_name": "Pantoprazole Teva Pharma 20 mg gastro-resistant tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/144/002", "product_name": "Pantoprazole Teva Pharma 40 mg gastro-resistant tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2010-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/148/001", "product_name": "Clarithromycin Teva 250 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-05-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/148/002", "product_name": "Clarithromycin Teva 500 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2012-05-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/160/001", "product_name": "Omeprazole Teva 10 mg gastro-resistant capsules, hard", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/160/002", "product_name": "Omeprazole Teva 20 mg gastro-resistant capsules, hard", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/160/003", "product_name": "Omeprazole Teva 40 mg Gastro-resistant Capsules, hard", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/164/001", "product_name": "Neurostil 100 mg capsules, hard", "holder": "Teva Pharma B.V.", "authorised_date": "2008-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/164/002", "product_name": "Neurostil 300 mg capsules, hard", "holder": "Teva Pharma B.V.", "authorised_date": "2008-09-26", "product_type": "HM", "market_status": "Not 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"PA0749/167/001", "product_name": "Dutasteride Teva 0.5 mg soft capsules", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G04CB", "G04CB02" ], "active_substances": [ "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/168/002", "product_name": "Perindopril Tosilate Teva 5mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tosilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/168/003", "product_name": "Perindopril Tosilate Teva 10mg Film-coated Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tosilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/170/001", "product_name": "Perindopril tosilate/indapamide Teva 2.5 mg/0.625 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BA", "C09BA04" ], "active_substances": [ "Perindopril tosilate", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/170/002", "product_name": "Perindopril tosilate/indapamide Teva 5 mg/1.25 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BA", "C09BA04" ], "active_substances": [ "Perindopril tosilate", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/177/001", "product_name": "Ramipril Teva Pharma 1.25mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/177/002", "product_name": "Ramipril Teva Pharma 2.5mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/177/003", "product_name": "Ramipril Teva Pharma 5mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/177/004", "product_name": "Ramipril Teva Pharma 10mg Tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/181/001", "product_name": "Voriconazole Teva 200 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2013-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J02AC", "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/185/001", "product_name": "Metformin Teva 500 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/185/002", "product_name": "Metformin Teva 850 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], 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be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/194/001", "product_name": "Donepezil Teva 5 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/194/002", "product_name": "Donepezil Teva 10 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/196/001", "product_name": "Alendronate/Colecalciferol Teva 70 mg/2800 IU tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2014-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BB", "M05BB03" ], "active_substances": [ "Alendronic acid", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/196/002", "product_name": "Alendronate/Colecalciferol Teva 70 mg/5600 IU tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2014-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BB", "M05BB03" ], "active_substances": [ "Alendronic acid", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/199/001", "product_name": "Gabitril 5 mg, film-coated tablet", "holder": "Teva Pharma B.V.", "authorised_date": "1997-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AG", "N03AG06" ], "active_substances": [ "Tiagabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/199/002", "product_name": "Gabitril 10 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "1997-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AG", "N03AG06" ], "active_substances": [ "Tiagabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/199/003", "product_name": "Gabitril 15 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "1997-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AG", "N03AG06" ], "active_substances": [ "Tiagabine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/204/001", "product_name": "Linezolid Teva 600 mg film-coated tablets", "holder": "Teva Pharma B.V.", "authorised_date": "2014-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/207/002", "product_name": "Budesonide Teva Pharma 0.5 mg/2 ml Nebuliser Suspension", "holder": "Teva Pharma B.V.", "authorised_date": "2014-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/207/003", "product_name": "Budesonide Teva Pharma 1 mg/2 ml Nebuliser Suspension", "holder": "Teva Pharma B.V.", "authorised_date": "2014-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/209/001", "product_name": "Nintedanib Teva Pharma 100 mg soft capsules", "holder": "Teva Pharma B.V.", "authorised_date": "2026-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0749/209/002", "product_name": "Nintedanib Teva Pharma 150 mg soft capsules", "holder": "Teva Pharma B.V.", "authorised_date": "2026-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0773/003/001", "product_name": "Lactulose Fresenius 670mg/ml oral solution", "holder": "Fresenius Kabi Austria GmbH", "authorised_date": "2010-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD", "A06AD11" ], "active_substances": [ "Lactulose" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0773/004/001", "product_name": "Lactulose 10 g/15 ml Oral Solution Sachets", "holder": "Fresenius Kabi Austria GmbH", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD", "A06AD11" ], "active_substances": [ "Lactulose" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0773/005/001", "product_name": "Laevolac Plum 10 g/15 ml oral solution", "holder": "Fresenius Kabi Austria GmbH", "authorised_date": "2014-07-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD", "A06AD11" ], "active_substances": [ "Lactulose" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/002/001", "product_name": "SPIRIVA 18 microgram, inhalation powder, hard capsule", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2002-06-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03BB", "R03BB04" ], "active_substances": [ "Tiotropium bromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/002/002", "product_name": "Spiriva Respimat 2.5 microgram inhalation solution", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation solution", "atc_codes": [ "R03BB", "R03BB04" ], "active_substances": [ "Tiotropium bromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/006/001", "product_name": "Striverdi Respimat 2.5 microgram inhalation solution", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2013-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation solution", "atc_codes": [ "R03AC19" ], "active_substances": [ "Olodaterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/009/001", "product_name": "Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2015-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation solution", "atc_codes": [ "R03BB", "R03BB54" ], "active_substances": [ "Tiotropium", "Olodaterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/011/001", "product_name": "Actilyse 10 mg powder and solvent for solution for injection and infusion", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "1994-09-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B01AD", "B01AD02" ], "active_substances": [ "Alteplase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/011/002", "product_name": "Actilyse 20 mg powder and solvent for solution for injection and infusion", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "1989-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B01AD", "B01AD02" ], "active_substances": [ "Alteplase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/011/003", "product_name": "Actilyse 50 mg powder and solvent for solution for injection and infusion", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "1989-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B01AD", "B01AD02" ], "active_substances": [ "Alteplase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/011/004", "product_name": "Actilyse Cathflo 2 mg powder for solution for injection and infusion", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B01AD02" ], "active_substances": [ "Alteplase" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/012/002", "product_name": "Atrovent 250 UDVs 250 micrograms/ 1ml Nebuliser Solution", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "1996-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03BB", "R03BB01" ], "active_substances": [ "Ipratropium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0775/012/003", "product_name": "Atrovent 500 UDVs, 500 micrograms/ 2ml Nebuliser Solution", "holder": "Boehringer Ingelheim International GmbH", "authorised_date": "1985-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03BB", "R03BB01" ], "active_substances": [ "Ipratropium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/001/001", "product_name": "Cipramil 10 mg film-coated tablets", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1995-09-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/001/002", "product_name": "Cipramil 20 mg film-coated tablets", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1995-09-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/001/004", "product_name": "Cipramil 40 mg/ml Oral drops, solution", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1999-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/002/001", "product_name": "Clopixol 200 mg/ml Solution for Injection", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1977-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AF", "N05AF05" ], "active_substances": [ "ZUCLOPENTHIXOL DECANOATE" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/002/002", "product_name": "Clopixol Conc. 500 mg/ml Solution for Injection", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1983-10-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AF", "N05AF05" ], "active_substances": [ "ZUCLOPENTHIXOL DECANOATE" ], "routes": [ "Submucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/002/003", "product_name": "Clopixol 10mg Film-coated Tablets", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1982-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AF", "N05AF05" ], "active_substances": [ "Zuclopenthixol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/003/001", "product_name": "Depixol 20mg/ml Solution for Injection", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1976-06-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AF", "N05AF01" ], "active_substances": [ "FLUPENTIXOL DECANOATE" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0776/003/002", "product_name": "Depixol Conc. 100mg/ml Solution for Injection", "holder": "Lundbeck ( Ireland ) Limited", "authorised_date": "1988-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AF", "N05AF01" ], "active_substances": [ "FLUPENTIXOL DECANOATE" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0788/001/002", "product_name": "ProHance, 279.3 mg/ml, Solution for Injection, 10 ml vial", "holder": "Bracco International B.V.", "authorised_date": "1993-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA04" ], "active_substances": [ "Gadoteridol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0788/001/003", "product_name": "ProHance, 279.3 mg/ml, Solution for Injection, 15 ml vial", "holder": "Bracco International B.V.", "authorised_date": "1993-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA04" ], "active_substances": [ "Gadoteridol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0788/001/004", "product_name": "ProHance, 279.3 mg/ml, solution for injection, 20 ml vial", "holder": "Bracco International B.V.", "authorised_date": "1993-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA04" ], "active_substances": [ "Gadoteridol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/006/002", "product_name": "Rhophylac 300 micrograms/2 ml, solution for injection in pre-filled syringe", "holder": "CSL Behring GmbH", "authorised_date": "2003-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J06BB", "J06BB01" ], "active_substances": [ "Human anti-D immunoglobulin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/007/001", "product_name": "Riastap 1 g Powder for Solution for Injection/Infusion", "holder": "CSL Behring GmbH", "authorised_date": "2010-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "B02BB", "B02BB01" ], "active_substances": [ "Human fibrinogen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/008/001", "product_name": "Alburex 5, 50 g/l, solution for infusion", "holder": "CSL Behring GmbH", "authorised_date": "2014-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Human albumin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/008/002", "product_name": "Alburex 20, 200 g/l, solution for infusion", "holder": "CSL Behring GmbH", "authorised_date": "2014-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Human albumin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/009/002", "product_name": "Tetagam P, prefilled syringeSolution for injection for intramuscular use", "holder": "CSL Behring GmbH", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion in pre-filled syringe", "atc_codes": [ "J06BB", "J06BB02" ], "active_substances": [ "Human plasma protein" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/010/001", "product_name": "Beriplex P/N 250 IU, powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2016-05-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD01" ], "active_substances": [ "Factor ii activity", "Factor vii activity", "Factor x activity", "Factor ix activity", "Protein c activity", "Protein s antigen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/010/002", "product_name": "Beriplex P/N 500 IU, powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2016-05-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD01" ], "active_substances": [ "Factor ii activity", "Factor vii activity", "Factor x activity", "Factor ix activity", "Protein c activity", "Protein s antigen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/010/003", "product_name": "Beriplex P/N 1000 IU, powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2016-05-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD01" ], "active_substances": [ "Factor ii activity", "Factor vii activity", "Factor x activity", "Factor ix activity", "Protein c activity", "Protein s antigen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/012/001", "product_name": "Human Albumin CSL Behring, 200 g/l, solution for infusion", "holder": "CSL Behring GmbH", "authorised_date": "2020-07-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA01" ], "active_substances": [ "Human albumin solution" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/013/001", "product_name": "Berinert 500 IU Powder and solvent for solution for injection/infusion.", "holder": "CSL Behring GmbH", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B06AC01" ], "active_substances": [ "C1 Esterase Inhibitor (Human)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/013/002", "product_name": "Berinert 1500 IU Powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B06AC01" ], "active_substances": [ "C1 Esterase Inhibitor (Human)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/013/003", "product_name": "Berinert 2000 IU Powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B06AC01" ], "active_substances": [ "C1 Esterase Inhibitor (Human)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0800/013/004", "product_name": "Berinert 3000 IU Powder and solvent for solution for injection", "holder": "CSL Behring GmbH", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B06AC01" ], "active_substances": [ "C1 Esterase Inhibitor (Human)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0803/004/001", "product_name": "Detrunorm 15 mg Film-coated Tablets", "holder": "Apogepha Arzneimittel GmbH", "authorised_date": "2008-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD06" ], "active_substances": [ "Propiverine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0803/005/001", "product_name": "Propinorm XL 30 mg Modified-Release Capsules", "holder": "APOGEPHA Arzneimittel GmbH", "authorised_date": "2007-09-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04BD", "G04BD06" ], "active_substances": [ "Propiverine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0803/006/001", "product_name": "Detrunorm XL 30 mg Modified-Release Capsules", "holder": "APOGEPHA Arzneimittel GmbH", "authorised_date": "2007-09-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04BD", "G04BD06" ], "active_substances": [ "Propiverine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0803/006/002", "product_name": "Detrunorm XL 45 mg Modified-Release Capsules", "holder": "APOGEPHA Arzneimittel GmbH", "authorised_date": "2011-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04BD", "G04BD06" ], "active_substances": [ "Propiverine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0805/002/001", "product_name": "Lexapro 5 mg film-coated tablets", "holder": "H. Lundbeck A/S", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0805/002/002", "product_name": "Lexapro 10 mg film-coated tablets", "holder": "H. Lundbeck A/S", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0805/002/003", "product_name": "Lexapro 15 mg film-coated tablets", "holder": "H. Lundbeck A/S", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0805/002/004", "product_name": "Lexapro 20 mg film-coated tablets", "holder": "H. Lundbeck A/S", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/001/001", "product_name": "Zanidip 10 mg film-coated tablets", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "2001-05-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0812/001/002", "product_name": "Zanidip 20mg film-coated tablets", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "2005-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA0812/002/001", "product_name": "Lomexin 2% w/w Cream", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC12" ], "active_substances": [ "Fenticonazole nitrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/002/005", "product_name": "Lomexin 2% w/v Cutaneous Spray, Solution", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous spray, solution", "atc_codes": [ "D01AC", "D01AC12" ], "active_substances": [ "Fenticonazole nitrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/004/001", "product_name": "Gynoxin 200 mg Vaginal Capsules", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "1992-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal capsule, soft", "atc_codes": [ "G01AF", "G01AF12" ], "active_substances": [ "Fenticonazole nitrate" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/004/002", "product_name": "Gynoxin 600 mg Vaginal Capsules", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "1992-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal capsule, soft", "atc_codes": [ "G01AF", "G01AF12" ], "active_substances": [ "Fenticonazole nitrate" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/005/001", "product_name": "ELIGARD 7.5 mg powder and solvent for solution for injection", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02AE", "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/005/002", "product_name": "ELIGARD 22.5 mg powder and solvent for solution for injection", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "2005-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02AE", "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0812/005/003", "product_name": "ELIGARD 45 mg powder and solvent for solution for injection", "holder": "Recordati Industria Chimica e Farmaceutica SpA", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02AE", "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0814/002/001", "product_name": "Itami 140 mg medicated plaster", "holder": "Fidia Farmaceutici S.p.A.", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0814/003/001", "product_name": "Flagyl-S 200mg/5ml Oral Suspension", "holder": "Fidia Farmaceutici S.p.A.", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "P01AB01" ], "active_substances": [ "Metronidazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0814/003/002", "product_name": "Flagyl 400mg Tablets", "holder": "Fidia Farmaceutici S.p.A.", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "P01AB01" ], "active_substances": [ "Metronidazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0814/004/001", "product_name": "Clomid 50 mg Tablets", "holder": "Fidia Farmaceutici S.p.A.", "authorised_date": "1982-12-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03GB", "G03GB02" ], "active_substances": [ "Clomiphene citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0815/004/001", "product_name": "Lamotrigine Desitin 10 mg/ml Oral Suspension", "holder": "Desitin Arzneimittel GmbH", "authorised_date": "2025-03-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0815/005/001", "product_name": "Ospolot 20 mg/ml Oral Suspension", "holder": "Desitin Arzneimittel GmbH", "authorised_date": "2024-10-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AX03" ], "active_substances": [ "Sultiame" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0815/006/001", "product_name": "Lamotrigine Desitin 5mg/ ml Oral Suspension", "holder": "Desitin Arzneimittel GmbH", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0815/007/001", "product_name": "Zonisamide Desitin 20 mg/ml oral suspension", "holder": "Desitin Arzneimittel GmbH", "authorised_date": "2024-10-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AX15" ], "active_substances": [ "Zonisamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/002/001", "product_name": "ARICEPT 5 mg film coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/002/002", "product_name": "ARICEPT 10 mg film coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/013/001", "product_name": "Ketalar 10mg/ml Solution for Injection/Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01AX", "N01AX03" ], "active_substances": [ "Ketamine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/013/002", "product_name": "Ketalar 50 mg/ml Solution for Injection/Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01AX", "N01AX03" ], "active_substances": [ "Ketamine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/014/002", "product_name": "Lopid 600 mg film-coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1989-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AB", "C10AB04" ], "active_substances": [ "Gemfibrozil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/019/001", "product_name": "Pro-Epanutin 75 mg/ml concentrate for solution for infusion/solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N03AB", "N03AB05" ], "active_substances": [ "Fosphenytoin sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/090/001", "product_name": "Ativan 1 mg Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA06" ], "active_substances": [ "Lorazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/093/001", "product_name": "Minulet 75 micrograms/30 micrograms coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1988-03-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AA10" ], "active_substances": [ "Gestodene", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/094/001", "product_name": "Ovranette 150 micrograms/30 micrograms coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1984-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AA", "G03AA07" ], "active_substances": [ "Ethinyloestradiol", "Levonorgestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/095/002", "product_name": "Premarin 0.625 mg Prolonged-release tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G03CA", "G03CA57" ], "active_substances": [ "Conjugated estrogens" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/095/003", "product_name": "Premarin 1.25 mg Prolonged-release tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1988-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G03CA", "G03CA57" ], "active_substances": [ "Conjugated estrogens" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/101/002", "product_name": "Zoton FasTab 15 mg Oro-Dispersible Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/101/003", "product_name": "Zoton FasTab 30 mg oro-dispersible tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/109/001", "product_name": "Mycobutin 150mg Hard Capsules", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J04AB", "J04AB04" ], "active_substances": [ "Rifabutin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/110/001", "product_name": "Aldactone 25 mg Film-coated Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/110/002", "product_name": "Aldactone 50 mg Film-coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1984-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/110/003", "product_name": "Aldactone 100 mg Film-coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1975-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/111/001", "product_name": "Aromasin 25 mg coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1999-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "L02BG", "L02BG06" ], "active_substances": [ "Exemestane" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/112/001", "product_name": "Arthrotec 50 modified-release tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1993-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AB", "M01AB55" ], "active_substances": [ "Diclofenac sodium", "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/112/002", "product_name": "Arthrotec 75 modified-release tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AB", "M01AB55" ], "active_substances": [ "Diclofenac sodium", "Lactose monohydrate", "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/114/001", "product_name": "Cabaser 1 mg Tablet", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1999-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC", "N04BC06" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/115/002", "product_name": "Caverject 10 micrograms Powder and Solvent for Solution for Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G04BE", "G04BE01" ], "active_substances": [ "Alprostadil" ], "routes": [ "Intracavernous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/115/003", "product_name": "Caverject 20 micrograms Powder and Solvent for Solution for Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1995-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G04BE", "G04BE01" ], "active_substances": [ "Alprostadil" ], "routes": [ "Intracavernous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/117/001", "product_name": "Cyklokapron 100 mg/mL solution for injection/infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B02AA", "B02AA02" ], "active_substances": [ "Tranexamic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/118/001", "product_name": "Cytotec 200 microgram tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1989-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A02BB", "A02BB01" ], "active_substances": [ "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/119/001", "product_name": "Dalacin 100 mg Vaginal Ovule", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G01AA", "G01AA10" ], "active_substances": [ "Clindamycin" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/119/002", "product_name": "Dalacin 2% vaginal cream", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1993-10-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G01AA", "G01AA10" ], "active_substances": [ "Clindamycin" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/120/001", "product_name": "Dalacin C 150 mg Hard Capsules", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1977-05-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FF", "J01FF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/120/002", "product_name": "Dalacin C Phosphate 150 mg/ml Concentrate for Solution for injection/infusion, 2ml", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1976-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for injection/infusion", "atc_codes": [ "J01FF", "J01FF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/120/003", "product_name": "Dalacin C Phosphate 150 mg/ml Concentrate for Solution for injection/infusion, 4ml", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1976-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for injection/infusion", "atc_codes": [ "J01FF", "J01FF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/121/001", "product_name": "Dalacin T Topical Lotion 10 mg/ml Cutaneous Emulsion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1991-01-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous emulsion", "atc_codes": [ "D10AF", "D10AF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/122/001", "product_name": "Depo-Medrone 40 mg/ml Suspension for Injection 1 ml vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone acetate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/122/002", "product_name": "Depo-Medrone 40 mg/ml Suspension for Injection 2 ml vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone acetate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/122/003", "product_name": "Depo-Medrone 40 mg/ml Suspension for Injection 3 ml vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1991-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone acetate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/123/002", "product_name": "Depo-Medrone 40mg/ml with Lidocaine 10mg/ml Suspension for Injection, 2ml vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1981-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone acetate", "Lidocaine hydrochloride" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/124/001", "product_name": "Depo-Provera 150 mg/ml Suspension for Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1996-01-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "G03AC", "G03AC06" ], "active_substances": [ "Medroxyprogesterone acetate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/126/001", "product_name": "Dostinex 500 microgram tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02CB", "G02CB03" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/127/001", "product_name": "Edronax® 4 mg tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06AX", "N06AX18" ], "active_substances": [ "Reboxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/001", "product_name": "GENOTROPIN 5.3 mg powder and solvent for solution for injection, with preservative", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1991-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/002", "product_name": "GENOTROPIN 12 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1992-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/003", "product_name": "GENOTROPIN MINIQUICK 0.2 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/004", "product_name": "GENOTROPIN MINIQUICK 0.4 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/005", "product_name": "GENOTROPIN MINIQUICK 0.6 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/006", "product_name": "GENOTROPIN MINIQUICK 0.8 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/007", "product_name": "GENOTROPIN MINIQUICK 1.0 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/008", "product_name": "GENOTROPIN MINIQUICK 1.2 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/009", "product_name": "GENOTROPIN MINIQUICK 1.4 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/010", "product_name": "GENOTROPIN MINIQUICK 1.6 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/011", "product_name": "GENOTROPIN MINIQUICK 1.8 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/128/012", "product_name": "GENOTROPIN MINIQUICK 2.0 mg powder and solvent for solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/129/001", "product_name": "Halcion 250 microgram Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1977-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05CD", "N05CD05" ], "active_substances": [ "Triazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/129/002", "product_name": "Halcion 125 micrograms Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1984-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05CD", "N05CD05" ], "active_substances": [ "Triazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/130/001", "product_name": "Loniten 5 mg tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1980-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02DC", "C02DC01" ], "active_substances": [ "Minoxidil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/131/001", "product_name": "Noriday 350 micrograms Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AC", "G03AC01" ], "active_substances": [ "Norethisterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/133/003", "product_name": "Prostin E2 1mg/ml Concentrate for solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "G02AD", "G02AD02" ], "active_substances": [ "Dinoprostone" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/134/003", "product_name": "Provera 10 mg tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1989-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03DA", "G03DA02" ], "active_substances": [ "Medroxyprogesterone acetate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/136/001", "product_name": "Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 40 mg/vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/136/002", "product_name": "Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 125 mg/vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/136/003", "product_name": "Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 500 mg/vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/136/004", "product_name": "Solu-Medrone powder and solvent for solution for injection or concentrate for solution for infusion 1000 mg/vial", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "H02AB", "H02AB04" ], "active_substances": [ "Methylprednisolone" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/137/001", "product_name": "Solu-Cortef 100 mg Powder for Solution for Injection or Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone sodium phosphate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/138/001", "product_name": "Synarel 200 micrograms/dose Nasal Spray Solution", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1997-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "H01CA", "H01CA02" ], "active_substances": [ "Nafarelin" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/142/005", "product_name": "Zavedos 1 mg/ml solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2019-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01DB", "L01DB06" ], "active_substances": [ "Idarubicin hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/143/001", "product_name": "Zyvox 100 mg/5 ml granules for oral suspension", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/143/002", "product_name": "Zyvox 2 mg/ml solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/143/004", "product_name": "Zyvox 600 mg film-coated tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/144/001", "product_name": "MINESSE 60 micrograms/15 micrograms film-coated tablet", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA10" ], "active_substances": [ "Gestodene", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/178/001", "product_name": "Prostin E2 1 mg Vaginal Gel", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1987-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal gel", "atc_codes": [ "G02AD", "G02AD02" ], "active_substances": [ "Dinoprostone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/178/002", "product_name": "Prostin E2 2 mg Vaginal Gel", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1987-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal gel", "atc_codes": [ "G02AD", "G02AD02" ], "active_substances": [ "Dinoprostone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/183/001", "product_name": "NeisVac-C 0.5 ml Suspension for injection in pre-filled syringe. Meningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AH" ], "active_substances": [ "Neisseria meningitidis c", "Tetanus toxoid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/184/001", "product_name": "TicoVac 0.5 ml Suspension for injection in a pre-filled syringeTick-Borne Encephalitis Vaccine (whole Virus, inactivated)", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2004-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BA", "J07BA01" ], "active_substances": [ "Tbe virus antigen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/184/002", "product_name": "TicoVac Junior 0.25 ml Suspension for injection in a pre-filled syringeTick-Borne Encephalitis Vaccine (whole Virus, inactivated)", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2004-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BA", "J07BA01" ], "active_substances": [ "TICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED) NEUDOERFL" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/190/002", "product_name": "Meronem I.V. 1g powder for solution for injection or infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1995-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/191/001", "product_name": "Zithromax 250 mg hard capsules", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1992-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FA", "J01FA10" ], "active_substances": [ "Azithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/191/002", "product_name": "Zithromax powder for oral suspension 200 mg/5 ml", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1992-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01FA", "J01FA10" ], "active_substances": [ "Azithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/193/001", "product_name": "Vibramycin Capsules 100 mg", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1977-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA", "J01AA02" ], "active_substances": [ "Doxycycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/195/001", "product_name": "Hypovase 0.5mg Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02CA", "C02CA01" ], "active_substances": [ "Prazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/196/001", "product_name": "Salazopyrin® EN Tabs 500 mg Gastro-resistant tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC", "A07EC01" ], "active_substances": [ "Sulfasalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/196/002", "product_name": "Salazopyrin® 500 mg Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A07EC", "A07EC01" ], "active_substances": [ "Sulfasalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/197/001", "product_name": "Trosyl 283 mg/ml Nail Solution", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1985-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D01AC", "D01AC07" ], "active_substances": [ "Tioconazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/198/001", "product_name": "Folinic Acid (as Calcium Folinate) 15mg Tablets", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1986-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "V03AF", "V03AF03" ], "active_substances": [ "Calcium folinate hydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/199/001", "product_name": "Cisplatin 1 mg/ml Concentrate for Solution for Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1986-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XA", "L01XA01" ], "active_substances": [ "Cisplatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/200/001", "product_name": "Cytarabine 20 mg/ml solution for injection or infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1989-11-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01BC", "L01BC01" ], "active_substances": [ "Cytarabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/200/002", "product_name": "Cytarabine 100 mg/ml solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1990-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BC", "L01BC01" ], "active_substances": [ "Cytarabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/201/001", "product_name": "Dexamethasone Phosphate 4 mg/ml Solution for Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1986-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/202/001", "product_name": "Dopamine Hydrochloride 40 mg/ml Sterile Concentrate", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1986-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA", "C01CA04" ], "active_substances": [ "DOPAMINE HYDROCHLORIDE" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/204/001", "product_name": "Glyceryl Trinitrate 5 mg/ml Sterile Concentrate", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1987-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/206/001", "product_name": "Methotrexate 5 mg/2 ml Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1984-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/206/002", "product_name": "Methotrexate Pfizer 50mg/2ml Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1984-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/206/006", "product_name": "Methotrexate 1 g/10 ml Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1988-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/206/007", "product_name": "Methotrexate 5 g/50 ml injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1999-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/207/001", "product_name": "Tobramycin 40 mg/ml Solution for Injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1993-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J01GB", "J01GB01" ], "active_substances": [ "Tobramycin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/208/001", "product_name": "Vinblastine Sulfate 1mg/ml Solution for Injection or Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1990-10-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01CA", "L01CA01" ], "active_substances": [ "VINBLASTINE SULFATE" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/211/001", "product_name": "Diflucan 50 mg hard capsules", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1988-08-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/211/002", "product_name": "Diflucan 150 mg hard capsules", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1988-08-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/211/003", "product_name": "Diflucan 200 mg hard capsules", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1989-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/211/004", "product_name": "Diflucan 2 mg/ml solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1989-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/211/006", "product_name": "Diflucan 10 mg/ml powder for oral suspension", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1991-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/211/007", "product_name": "Diflucan 40 mg/ml powder for oral suspension", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1991-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/212/001", "product_name": "CAMPTO 20 mg/mL concentrate for solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2008-02-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX19" ], "active_substances": [ "Irinotecan hydrochloride trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/215/001", "product_name": "Aciclovir 25mg/ml concentrate for solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/218/001", "product_name": "Octreotide 50 micrograms/1 ml solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2007-06-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide acetate" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/218/002", "product_name": "Octreotide 100 micrograms/1 ml solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2007-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide acetate" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/218/004", "product_name": "Octreotide 500 micrograms/1 ml solution for injection", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2007-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide acetate" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/219/001", "product_name": "Noradrenaline (Norepinephrine) 1:1000 Concentrate For Solution For Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1995-04-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA", "C01CA03" ], "active_substances": [ "Noradrenaline acid tartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/223/001", "product_name": "Fluorouracil 25 mg/ml Solution for Injection or Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1986-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01BC", "L01BC02" ], "active_substances": [ "Fluorouracil sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/228/001", "product_name": "NIPENT 10 mg powder for solution for injection, powder for solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1993-04-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01XX", "L01XX08" ], "active_substances": [ "Pentostatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/232/001", "product_name": "Vincristine Sulfate 1mg/ml Solution for Injection or Infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "1987-05-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01CA", "L01CA02" ], "active_substances": [ "Vincristine sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0822/238/001", "product_name": "Atgam 50 mg/ml concentrate for solution for infusion", "holder": "Pfizer Healthcare Ireland Unlimited Company", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA03" ], "active_substances": [ "Anti-T Lymphocyte Immunoglobulin for Human Use, Horse" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0840/004/001", "product_name": "Anastrozole Synthon 1 mg film-coated tablets", "holder": "Synthon BV", "authorised_date": "2007-09-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0840/009/001", "product_name": "Letrozole Synthon 2.5 mg film-coated tablets", "holder": "Synthon BV", "authorised_date": "2008-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0840/013/001", "product_name": "Tamsulosin Hydrochloride 400 micrograms Modified-release Capsules, hard", "holder": "Synthon BV", "authorised_date": "2006-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0846/001/001", "product_name": "Letybo 50 units powder for solution for injection", "holder": "Croma-Pharma GmbH", "authorised_date": "2022-03-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Clostridium Botulinum Neurotoxin Type A (900 KD)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0846/003/001", "product_name": "Pliaglis 70mg/g + 70mg/g cream", "holder": "Croma-Pharma GmbH", "authorised_date": "2012-07-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Lidocaine", "Tetracaine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0849/001/001", "product_name": "Fanhdi 250 IU powder and solvent for solution for injection", "holder": "Instituto Grifols S.A.", "authorised_date": "2000-07-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Human coagulation factor viii" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0849/001/002", "product_name": "Fanhdi 500 IU powder and solvent for solution for injection", "holder": "Instituto Grifols S.A.", "authorised_date": "2000-07-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Human coagulation factor viii" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0849/001/003", "product_name": "Fanhdi 1000 IU powder and solvent for solution for injection", "holder": "Instituto Grifols S.A.", "authorised_date": "2000-07-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Human coagulation factor viii" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0849/006/001", "product_name": "Albutein, 50 gram(s)/litre, solution for infusion", "holder": "Instituto Grifols S.A.", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA01" ], "active_substances": [ "Human albumin solution" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0849/006/002", "product_name": "Albutein, 200 gram(s)/litre, solution for infusion", "holder": "Instituto Grifols S.A.", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA01" ], "active_substances": [ "Human albumin solution" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0857/001/001", "product_name": "Glycopyrronium Bromide 200 micrograms/ml Solution for Injection", "holder": "MercuryPharm Ltd", "authorised_date": "1981-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A03AB", "A03AB02" ], "active_substances": [ "Glycopyrronium bromide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0857/002/001", "product_name": "Glycopyrronium Bromide and Neostigmine Metilsulfate 0.5mg/2.5mg per ml Solution for Injection", "holder": "MercuryPharm Ltd", "authorised_date": "1986-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N07AA", "N07AA51" ], "active_substances": [ "Glycopyrronium bromide", "Neostigmine Metilsulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0857/003/001", "product_name": "Doxapram Hydrochloride 2mg/ml Solution for Infusion", "holder": "MercuryPharm Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "R07AB", "R07AB01" ], "active_substances": [ "Doxapram hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0857/003/002", "product_name": "Doxapram Hydrochloride 20mg/ml Solution for Injection", "holder": "MercuryPharm Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "R07AB", "R07AB01" ], "active_substances": [ "Doxapram hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0864/001/001", "product_name": "Galtasa 500 mg gastro-resistant tablets", "holder": "Faes Farma S.A.", "authorised_date": "2020-10-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0864/001/002", "product_name": "Galtasa 500 mg suppositories", "holder": "Faes Farma S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0864/001/003", "product_name": "Galtasa 1000 mg gastro-resistant tablets", "holder": "Faes Farma S.A.", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0864/001/004", "product_name": "Galtasa 1500 mg gastro-resistant tablets", "holder": "Faes Farma S.A.", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0864/003/001", "product_name": "Calcifediol Faes 72 microgram soft capsules", "holder": "Faes Farma S.A.", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC06" ], "active_substances": [ "Calcifediol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/002/002", "product_name": "Keral 25 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "1998-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE17" ], "active_substances": [ "Dexketoprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/002/003", "product_name": "Keral 50 mg/2ml solution for injection/infusion", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2004-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M01AE", "M01AE17" ], "active_substances": [ "Dexketoprofen trometamol" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/002/005", "product_name": "Keral 25mg granules for oral solution", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-09-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "M01AE", "M01AE17" ], "active_substances": [ "Dexketoprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/002/006", "product_name": "Keral 25 mg oral solution in sachet", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2017-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution in sachet", "atc_codes": [ "M01AE", "M01AE17" ], "active_substances": [ "Dexketoprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/003/001", "product_name": "ZOFENIL 7.5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "1999-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA15" ], "active_substances": [ "Zofenopril calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/003/003", "product_name": "ZOFENIL 30 mg film-coated tablet", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "1999-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09AA", "C09AA15" ], "active_substances": [ "Zofenopril calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/005/001", "product_name": "Nebilet 5 mg tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "1996-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB12" ], "active_substances": [ "Nebivolol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/011/001", "product_name": "Omesar 10 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2003-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/011/002", "product_name": "Omesar 20 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2003-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/011/003", "product_name": "Omesar 40 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2003-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/012/001", "product_name": "Zofenil Plus 30 mg/12.5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2005-05-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BA", "C09BA15" ], "active_substances": [ "Zofenopril calcium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/014/001", "product_name": "Omesar Plus 20 mg/12.5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2006-03-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/014/002", "product_name": "Omesar Plus 20 mg/25 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2006-03-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/014/003", "product_name": "Omesar Plus 40 mg/12.5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2010-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/014/004", "product_name": "Omesar Plus 40 mg/25 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2010-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/015/001", "product_name": "Nebilet Plus 5 mg/12.5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2009-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07BB", "C07BB12" ], "active_substances": [ "Nebivolol", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/015/002", "product_name": "Nebilet Plus 5 mg/25 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2009-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07BB", "C07BB12" ], "active_substances": [ "Nebivolol", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/017/001", "product_name": "Konverge 20 mg/5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/017/002", "product_name": "Konverge 40 mg/5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/017/003", "product_name": "Konverge 40 mg/10 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/018/001", "product_name": "Drynol 20 mg Tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX29" ], "active_substances": [ "Bilastine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/018/002", "product_name": "Drynol 10 mg orodispersible tablet", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "R06AX", "R06AX29" ], "active_substances": [ "Bilastine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/018/003", "product_name": "Drynol 2.5 mg/ml oral solution", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AX", "R06AX29" ], "active_substances": [ "Bilastine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/018/004", "product_name": "Drynol 20 mg orodispersible tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2023-03-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "R06AX29" ], "active_substances": [ "Bilastine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/018/005", "product_name": "Drynol 6 mg/mL eye drops, solution", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2022-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX13" ], "active_substances": [ "Bilastine" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/019/001", "product_name": "Konverge Plus 20 mg/5 mg/12.5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/019/002", "product_name": "Konverge Plus 40mg/5mg/12.5mg film coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/019/003", "product_name": "Konverge Plus 40mg/10mg/12.5mg film coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/019/004", "product_name": "Konverge Plus 40mg/5mg/25mg film coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/019/005", "product_name": "Konverge Plus 40mg/10mg/25mg film coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX", "C09DX03" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/020/001", "product_name": "Skudexa 75 mg/25 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2016-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ14" ], "active_substances": [ "Dexketoprofen", "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/020/003", "product_name": "Skudexa 75 mg/25 mg granules for oral solution in sachet", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2018-04-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution in sachet", "atc_codes": [ "N02AJ", "N02AJ14" ], "active_substances": [ "Tramadol hydrochloride", "Dexketoprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/021/001", "product_name": "Nebkliq 5 mg/5 mg film-coated tablet", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "QC07FB12" ], "active_substances": [ "Nebivolol hydrochloride", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/021/002", "product_name": "Nebkliq 5 mg/10 mg film-coated tablet", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "QC07FB12" ], "active_substances": [ "Nebivolol hydrochloride", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/022/001", "product_name": "Twilev 2.5 mg/5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX" ], "active_substances": [ "Ramipril", "Nebivolol hydrochloride" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/022/002", "product_name": "Twilev 5 mg/5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX" ], "active_substances": [ "Ramipril", "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0865/022/003", "product_name": "Twilev 10 mg/5 mg film-coated tablets", "holder": "Menarini International Operations Luxembourg S.A.", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX" ], "active_substances": [ "Ramipril", "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0868/003/001", "product_name": "EPINITRIL 5 mg/24 h transdermal patch", "holder": "Rottapharm Ltd", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0868/003/002", "product_name": "EPINITRIL 10 mg/24 h transdermal patch", "holder": "Rottapharm Ltd", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0868/003/003", "product_name": "EPINITRIL 15 mg/24 h transdermal patch", "holder": "Rottapharm Ltd", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0868/006/001", "product_name": "DERMATRANS 5 mg/24 h transdermal patch", "holder": "Rottapharm Ltd", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0868/006/002", "product_name": "DERMATRANS 10 mg/24 h transdermal patch", "holder": "Rottapharm Ltd", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0868/006/003", "product_name": "DERMATRANS 15 mg/24 h transdermal patch", "holder": "Rottapharm Ltd", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/003/001", "product_name": "Decapeptyl SR, 3 mg powder and solvent for suspension for injection", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "1989-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "L02AE", "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/003/002", "product_name": "Decapeptyl 3-month, 11.25 mgPowder and solvent for suspension for injection", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "1998-10-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "L02AE", "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/003/003", "product_name": "Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "2011-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "L02AE", "L02AE04" ], "active_substances": [ "Triptorelin pamoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/004/002", "product_name": "Somatuline Autogel 60 mg, solution for injection in a prefilled syringe", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "2002-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB", "H01CB03" ], "active_substances": [ "Lanreotide acetate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/004/003", "product_name": "Somatuline Autogel 90mg, solution for injection in a pre-filled syringe", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "2002-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB", "H01CB03" ], "active_substances": [ "Lanreotide acetate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/004/004", "product_name": "Somatuline Autogel 120mg, solution for injection in a pre-filled syringe", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "2002-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB", "H01CB03" ], "active_substances": [ "Lanreotide acetate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0869/008/001", "product_name": "Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension for injection", "holder": "Ipsen Pharmaceuticals Limited", "authorised_date": "2015-08-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "L02AE", "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/008/001", "product_name": "Solifenacin TAD 5 mg film-coated tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2017-11-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/008/002", "product_name": "Solifenacin TAD 10 mg film-coated tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2017-11-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/009/001", "product_name": "Everolimus TAD 2.5 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/009/002", "product_name": "Everolimus TAD 5 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/009/003", "product_name": "Everolimus TAD 10 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01XE", "L01XE10" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/010/001", "product_name": "Perindopril Arginine TAD 5 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/010/002", "product_name": "Perindopril Arginine TAD 10 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA04" ], "active_substances": [ "Perindopril arginine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/011/001", "product_name": "Perindopril arginine/Indapamide TAD 5 mg/1.25 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2022-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA04" ], "active_substances": [ "Perindopril arginine", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/011/002", "product_name": "Perindopril arginine/Indapamide TAD 10 mg/2.5 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2022-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA04" ], "active_substances": [ "Perindopril arginine", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/012/001", "product_name": "Perindopril arginine/amlodipine TAD 5 mg/5 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/012/002", "product_name": "Perindopril arginine/amlodipine TAD 5 mg/10 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/012/003", "product_name": "Perindopril arginine/amlodipine TAD 10 mg/5 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0876/012/004", "product_name": "Perindopril arginine/amlodipine TAD 10 mg/10 mg tablets", "holder": "TAD Pharma GmbH", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0879/003/001", "product_name": "Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container", "holder": "Santen OY", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Tafluprost", "Timolol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0879/004/001", "product_name": "TRUSOPT 20 mg/ml eye drops, solution", "holder": "Santen OY", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EC03" ], "active_substances": [ "Dorzolamide hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0879/004/002", "product_name": "TRUSOPT Preservative-Free 20 mg/ml eye drops, solution in single-dose container", "holder": "Santen OY", "authorised_date": "2006-06-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01EC", "S01EC03" ], "active_substances": [ "Dorzolamide hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0879/005/001", "product_name": "COSOPT 20mg/ml + 5mg/ml eye drops, solution", "holder": "Santen OY", "authorised_date": "1998-08-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Dorzolamide hydrochloride", "Timolol Maleate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0879/006/001", "product_name": "Saflutan 15 micrograms/ml, eye drops, solution in single-dose container", "holder": "Santen OY", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01EE", "S01EE05" ], "active_substances": [ "Tafluprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0879/009/001", "product_name": "Ducressa 1 mg/ml + 5 mg/ml, eye drops, solution", "holder": "Santen OY", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01CA01" ], "active_substances": [ "Levofloxacin", "Dexamethasone" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0885/001/001", "product_name": "Veletri 0.5 Milligram Powder for Solution for Infusion", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "B01AC", "B01AC09" ], "active_substances": [ "EPOPROSTENOL SODIUM" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0885/001/002", "product_name": "Veletri 1.5 Milligram Powder for Solution for Infusion", "holder": "Janssen-Cilag International NV", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "B01AC", "B01AC09" ], "active_substances": [ "EPOPROSTENOL SODIUM" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/003/001", "product_name": "Xyzal 5 mg film-coated tablets", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "2001-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/003/002", "product_name": "Xyzal 5 mg/ml oral drops, solution", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "2005-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "R06AE", "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/003/003", "product_name": "Xyzal 0.5 mg/ml oral solution", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "2006-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE", "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/008/001", "product_name": "Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablet", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "2006-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "R01BA", "R01BA52" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE", "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/008/002", "product_name": "Zirtek 10 mg film-coated tablets", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "1988-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/008/003", "product_name": "Zirtek 1 mg/ml oral solution", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "1993-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/008/004", "product_name": "Zirtek 10 mg/ml Oral Drops, Solution", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/008/005", "product_name": "Zirtek Allergy Relief 10 mg film-coated tablets", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "2015-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0891/014/001", "product_name": "Tylex 30 mg/500 mg Hard Capsules", "holder": "UCB (Pharma) Ireland Limited,", "authorised_date": "1997-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Codeine phosphate hemihydrate", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/004/001", "product_name": "Cataflam 50mg Coated Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1995-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/005/001", "product_name": "Certican 0.25mg Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AA", "L04AA18" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/005/003", "product_name": "Certican 0.75mg Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AA", "L04AA18" ], "active_substances": [ "Everolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/006/001", "product_name": "Ciloxan 3 mg/ml ear drops, solution", "holder": "Novartis Ireland Limited", "authorised_date": "2006-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear drops, solution", "atc_codes": [ "S02AA", "S02AA15" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Auricular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/007/001", "product_name": "Co-Diovan 80 mg/12.5 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/007/002", "product_name": "Co-Diovan 160 mg/12.5 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2003-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/007/003", "product_name": "Co-Diovan 160 mg/25 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2004-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/007/004", "product_name": "Co-Diovan 320 mg/12.5 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/007/005", "product_name": "Co-Diovan 320 mg/25 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/009/001", "product_name": "Diovan 80 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2001-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/009/002", "product_name": "Diovan 160 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2001-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/009/003", "product_name": "Diovan 40 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2005-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/009/004", "product_name": "Diovan 320 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/009/005", "product_name": "Diovan 3mg/ml oral solution", "holder": "Novartis Ireland Limited", "authorised_date": "2010-05-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/012/001", "product_name": "Femara 2.5 mg film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1997-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/017/001", "product_name": "Lioresal 10 mg Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1983-01-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX01" ], "active_substances": [ "Baclofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/017/002", "product_name": "Lioresal 5mg/5ml Oral solution", "holder": "Novartis Ireland Limited", "authorised_date": "1984-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "M03BX", "M03BX01" ], "active_substances": [ "Baclofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/018/001", "product_name": "Maxidex 0.1% w/v Eye Drops, Suspension", "holder": "Novartis Ireland Limited", "authorised_date": "1984-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01BA", "S01BA01" ], "active_substances": [ "Dexamethasone" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/019/001", "product_name": "Maxitrol 0.1% w/v, 6000 IU/ml, 3500 IU/ml eye drops, suspension", "holder": "Novartis Ireland Limited", "authorised_date": "1988-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01CA", "S01CA01" ], "active_substances": [ "Dexamethasone", "Polymyxin b sulfate", "Neomycin sulfate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/023/001", "product_name": "Myfortic 180 mg gastro-resistant tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2004-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/023/002", "product_name": "Myfortic 360 mg gastro-resistant tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2004-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/024/001", "product_name": "Neoral 25 mg Soft Capsules", "holder": "Novartis Ireland Limited", "authorised_date": "1995-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/024/002", "product_name": "Neoral 50mg Soft Capsules", "holder": "Novartis Ireland Limited", "authorised_date": "1995-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/024/003", "product_name": "Neoral 100mg Soft Capsules", "holder": "Novartis Ireland Limited", "authorised_date": "1995-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/024/004", "product_name": "Neoral 100 mg/ml concentrate for oral solution", "holder": "Novartis Ireland Limited", "authorised_date": "1995-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for oral solution", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/027/002", "product_name": "Sandimmun 50 mg/ml Concentrate for Solution for Infusion", "holder": "Novartis Ireland Limited", "authorised_date": "1984-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/028/001", "product_name": "SANDOSTATIN 50 microgram/1 ml, solution for injection/infusion", "holder": "Novartis Ireland Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/028/002", "product_name": "SANDOSTATIN 100 microgram/1ml, solution for injection/infusion", "holder": "Novartis Ireland Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/028/003", "product_name": "SANDOSTATIN 500 microgram/1 ml, solution for injection/infusion", "holder": "Novartis Ireland Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/028/004", "product_name": "Sandostatin LAR 10 mg powder and solvent for suspension for injection", "holder": "Novartis Ireland Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/028/005", "product_name": "Sandostatin LAR 20 mg powder and solvent for suspension for injection", "holder": "Novartis Ireland Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/028/006", "product_name": "Sandostatin LAR 30 mg powder and solvent for suspension for injection", "holder": "Novartis Ireland Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/030/001", "product_name": "Tegretol 100mg/5ml Oral Suspension", "holder": "Novartis Ireland Limited", "authorised_date": "1974-12-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/030/002", "product_name": "Tegretol 100mg Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/030/003", "product_name": "Tegretol 200mg Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/030/004", "product_name": "Tegretol 400mg Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/030/005", "product_name": "Tegretol SR 200mg prolonged release tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1993-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/030/006", "product_name": "Tegretol SR 400mg prolonged release tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1993-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/033/001", "product_name": "Trileptal 150 mg Film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/033/002", "product_name": "Trileptal 300 mg Film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/033/003", "product_name": "Trileptal 600 mg Film-coated tablets", "holder": "Novartis Ireland Limited", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/033/004", "product_name": "Trileptal 60 mg/ml Oral Suspension", "holder": "Novartis Ireland Limited", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/034/001", "product_name": "Voltarol 50 mg Gastro-Resistant Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1979-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/034/002", "product_name": "Voltarol Retard 100 mg Film-coated Prolonged Release Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1983-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0896/034/003", "product_name": "Voltarol Retard 75 mg Film-coated Prolonged-release Tablets", "holder": "Novartis Ireland Limited", "authorised_date": "1991-12-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0919/004/003", "product_name": "Menjugate 10 micrograms suspension for injection Meningococcal group C conjugate vaccine", "holder": "Glaxosmithkline Vaccines S.r.l.", "authorised_date": "2015-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AH", "J07AH05" ], "active_substances": [ "Meningococcal group c oligosaccharide", "Corynebacterium diphtheriae crm197 protein" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0919/004/004", "product_name": "Menjugate 10 micrograms suspension for injection Meningococcal group C conjugate vaccine", "holder": "Glaxosmithkline Vaccines S.r.l.", "authorised_date": "2015-05-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "J07AH", "J07AH05" ], "active_substances": [ "Meningococcal group c oligosaccharide", "Corynebacterium diphtheriae crm197 protein" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0928/001/001", "product_name": "Normosang 25 mg/ml, concentrate for solution for infusion", "holder": "Recordati Rare Diseases", "authorised_date": "1999-06-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B06AB", "B06AB01" ], "active_substances": [ "Human hemin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0949/001/001", "product_name": "Venofer 20 mg iron/mL solution for injection or concentrate for solution for infusion, ampoule", "holder": "Vifor France", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B03AB", "B03AB02" ], "active_substances": [ "IRON (III)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0949/001/002", "product_name": "Venofer 20 mg iron/mL solution for injection or concentrate for solution for infusion, vial", "holder": "Vifor France", "authorised_date": "2009-09-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B03AB", "B03AB02" ], "active_substances": [ "Iron (iii) - hydroxide sucrose complex" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0949/004/001", "product_name": "Ferinject 50 mg iron/mL dispersion for injection/infusion", "holder": "Vifor France", "authorised_date": "2008-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersion for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "IRON CARBOXYMALTOSE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0964/009/001", "product_name": "Arcoxia 30 mg film-coated tablets", "holder": "NV Organon", "authorised_date": "2007-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0964/009/002", "product_name": "Arcoxia 60 mg film-coated tablets", "holder": "NV Organon", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0964/009/003", "product_name": "Arcoxia 90 mg film-coated tablets", "holder": "NV Organon", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0964/009/004", "product_name": "Arcoxia 120 mg film-coated tablets", "holder": "NV Organon", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0968/001/001", "product_name": "Almogran 12.5 mg film-coated tablet", "holder": "Almirall, S.A.", "authorised_date": "2000-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC05" ], "active_substances": [ "Almotriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0968/004/001", "product_name": "Solaraze 3% gel", "holder": "Almirall, S.A.", "authorised_date": "2003-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D11AX18" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0968/005/001", "product_name": "Meptid 100 mg/ml Solution for Injection", "holder": "Almirall, S.A.", "authorised_date": "1983-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AX", "N02AX05" ], "active_substances": [ "Meptazinol" ], "routes": [ "Intramuscular use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0968/005/002", "product_name": "Meptid 200 mg film-coated Tablets", "holder": "Almirall, S.A.", "authorised_date": "1988-05-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX", "N02AX05" ], "active_substances": [ "Meptazinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0968/006/001", "product_name": "Wynzora 50 micrograms/g + 0.5 mg/g cream", "holder": "Almirall, S.A.", "authorised_date": "2021-12-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/001/001", "product_name": "Bonjela Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010%", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal gel", "atc_codes": [ "N02BA", "N02BA03" ], "active_substances": [ "Choline salicylate", "Cetalkonium chloride" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/001/003", "product_name": "Bonjela Teething Gel Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010%", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2010-03-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal gel", "atc_codes": [ "N02BA", "N02BA03" ], "active_substances": [ "Choline salicylate", "Cetalkonium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/004/002", "product_name": "Dettol Antiseptic Disinfectant 4.8% w/v, concentrate for cutaneous solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for cutaneous solution", "atc_codes": [ "D08AE", "D08AE05" ], "active_substances": [ "Chloroxylenol" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/006/001", "product_name": "Disprin Original 300 mg Dispersible Tablets", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N02BA", "N02BA01" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/006/002", "product_name": "Disprin Extra Strength 500 mg Effervescent tablets", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1998-09-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BA", "N02BA01" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/007/001", "product_name": "Disprin Direct 300 mg Orodispersible Tablets", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1983-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02BA", "N02BA01" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/009/001", "product_name": "Fybogel Citrus 3.5 g Granules", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1975-01-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "A06AC", "A06AC01" ], "active_substances": [ "Ispaghula husks" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/009/002", "product_name": "Fybogel Orange 3.5 g granules", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "1993-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules", "atc_codes": [ "A06AC", "A06AC01" ], "active_substances": [ "Ispaghula husks" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/010/001", "product_name": "Fybogel Mebeverine Granules for Oral Suspension Ispaghula Husk 3.5g Mebeverine Hydrochloride 135mg", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1986-03-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "A06AC", "A06AC51" ], "active_substances": [ "Mebeverine hydrochloride", "Ispaghula husks" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/011/001", "product_name": "Gaviscon Advance Oral Suspension Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg.", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1998-08-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX" ], "active_substances": [ "Sodium alginate", "Potassium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/011/006", "product_name": "Gaviscon Advance Peppermint Oral Suspension Sachets Sodium Alginate 500mg, Potassium hydrogen carbonate 100 mg Oral suspension.", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2004-03-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Potassium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/011/007", "product_name": "Gaviscon Advance Peppermint Oral Suspension Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg.", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2004-03-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Potassium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/011/008", "product_name": "Gaviscon Advance Chewable Tablets Sodium alginate 500 mg, Potassium hydrogen carbonate 100 mg.", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2006-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Potassium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/012/001", "product_name": "Gaviscon Infant, Powder for Oral Suspension", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1991-07-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Magnesium alginate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/013/001", "product_name": "Lemsip Cold & Flu Hot Lemon 500 mg Powder for Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/014/001", "product_name": "Lemsip Cold & Flu Headcold 500 mg Powder for Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1994-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/001", "product_name": "Gaviscon Oral Suspension 500mg/10ml Sodium Alginate 267mg/10ml Sodium Bicarbonate 160mg/10ml Calcium Carbonate", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1978-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX" ], "active_substances": [ "Sodium bicarbonate", "Calcium carbonate", "Sodium alginate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/002", "product_name": "Gaviscon Liquid Peppermint Flavour, Oral Suspension Sodium alginate 500 mg Sodium bicarbonate 267 mg Calcium carbonate 160 mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1996-01-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02AX" ], "active_substances": [ "Sodium alginate", "Calcium carbonate", "Sodium bicarbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/003", "product_name": "Gaviscon Liquid-Aniseed Flavour, Oral Suspension Each 10 ml contains: Sodium alginate 500 mg Sodium bicarbonate 267 mg Calcium carbonate 160 mg", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2001-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX" ], "active_substances": [ "Sodium bicarbonate", "Calcium carbonate", "Sodium alginate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/004", "product_name": "Gaviscon Peppermint Chewable Tablets Sodium alginate 250 mg Sodium hydrogen Carbonate 133.5 mg Calcium Carbonate 80 mg", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2004-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium hydrogen carbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/005", "product_name": "Gaviscon Strawberry Chewable Tablets Sodium alginate 250mg Sodium hydrogen Carbonate 133.5mg Calcium Carbonate 80mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2004-12-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium hydrogen carbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/010", "product_name": "Gaviscon Liquid Sachets Oral Suspension Sodium alginate 500mg, Sodium bicarbonate 267mg, Calcium carbonate 160mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension in sachet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium bicarbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/011", "product_name": "Gaviscon Extra Oral Suspension Sodium alginate 500 mg Sodium bicarbonate 213 mg Calcium carbonate 325 mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium bicarbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/012", "product_name": "Gaviscon Extra Chewable TabletsSodium alginate 250mgSodium bicarbonate 106.5mgCalcium carbonate 187.5mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium bicarbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/015/013", "product_name": "Gaviscon Extra Liquid Sachets Peppermint Flavour Oral SuspensionSodium Alginate 500 mg/10 ml Sodium Bicarbonate 213 mg/10 ml Calcium Carbonate 325 mg/10 ml", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2012-12-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension in sachet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium bicarbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/016/002", "product_name": "Senokot 7.5mg Tablets", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A06AB", "A06AB06" ], "active_substances": [ "Senna pods powdered" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/016/003", "product_name": "Senokot 7.5 mg/5 ml Syrup", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2006-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "A06AB", "A06AB06" ], "active_substances": [ "Sennosides" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/020/001", "product_name": "Lemsip Max Sinus & Flu Hot Lemon Powder for Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1996-05-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/021/001", "product_name": "Lemsip Max Cold and Flu Hot Lemon 1000mg Powder for Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1999-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/021/003", "product_name": "Lemsip Max Cold and Flu Blackcurrant 1000 mg Powder for Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/022/001", "product_name": "Paracetamol Tablets 500 mg from the makers of Disprin", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2001-10-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/025/001", "product_name": "Lemsip Dry Cough 0.25ml/5ml Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2006-04-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05X" ], "active_substances": [ "Glycerol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/026/001", "product_name": "Lemsip Chesty Cough 50mg/5ml Oral Solution", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2006-04-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CA", "R05CA03" ], "active_substances": [ "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/027/001", "product_name": "Lemsip Decongestant & Flu Capsules with CaffeineParacetamol 500mgPhenylephine Hydrochloride 6.1mgCaffeine 25mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2007-11-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Phenylephrine hydrochloride", "Caffeine anhydrous" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/028/001", "product_name": "Lemsip Max Cough & Cold Powder for Oral Solution Paracetamol 1000 mg Guaifenesin 200 mg", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2007-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/029/001", "product_name": "Lemsip Cough and Cold Capsules with CaffeineParacetamol 500mgGuaifenesin 100mgCaffeine 25mg", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2007-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Guaifenesin", "Caffeine anhydrous" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/001", "product_name": "Nurofen for Children Orange 100 mg/5 ml oral suspension", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1998-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/003", "product_name": "Nurofen 5% w/w Gel", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2000-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA13" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/005", "product_name": "Nurofen for Children Meltlets 100mg Orodispersible Tablets", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/006", "product_name": "Nurofen 200 mg Coated Tablets", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2004-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/007", "product_name": "Nurofen for Children 60 mg Suppositories Age 3 months to 2 years", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2008-09-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/008", "product_name": "Nurofen for Children Sachets 100 mg/5 ml Oral Suspension", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2010-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/009", "product_name": "Nurofen for Children Strawberry 100 mg/5 ml oral suspension", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2008-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/010", "product_name": "Nurofen Express 200 mg Tablets", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2011-05-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/011", "product_name": "Nurofen Express Maximum Strength 400 mg Tablets", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2011-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/012", "product_name": "Nurofen Rapid Relief 200mg Liquid Capsules", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/013", "product_name": "Nurofen Rapid Relief Maximum Strength 400mg Liquid Capsules", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/015", "product_name": "Nurofen Long Lasting 300 mg Prolonged Release Hard Capsules", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1992-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/032/018", "product_name": "Nurofen Durance 200 mg medicated plaster", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2017-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AA", "M02AA13" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/033/001", "product_name": "Nurofen Cold & Flu Film-coated Tablets Ibuprofen 200mg Pseudophedrine hydrochloride 30mg", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1994-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE51" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/034/001", "product_name": "Nurofen Plus Tablets Ibuprofen 200mg Codeine Phosphate Hemihydrate 12.8mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1997-03-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ08" ], "active_substances": [ "Ibuprofen", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/038/002", "product_name": "Strepsils Honey & Lemon Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl alcohol 1.2mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1986-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "2,4-Dichlorobenzyl alcohol" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/038/003", "product_name": "Strepsils Strawberry Sugar Free Lozenges Amylmetacresol 600 micrograms 2, 4-Dichlorobenzyl Alcohol 1.2 mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1997-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "2, 4-dichlorobenzyl alcohol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/039/001", "product_name": "Strepsils Orange with Vitamin C Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Vitamin C 100mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1985-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "2, 4-dichlorobenzyl alcohol", "Vitamin c" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/040/001", "product_name": "Strepsils +Plus Anaesthetic Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Lidocaine Hydrochloride 10mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1995-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "2, 4-dichlorobenzyl alcohol", "Lidocaine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/040/002", "product_name": "Strepsils +Plus Anaesthetic Throat Spray Amylmetacresol 0.29mg/spray 2,4-Dichlorobenzyl Alcohol 0.58mg/spray Lidocaine 0.78mg/spray", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1996-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "2,4-Dichlorobenzyl alcohol", "Lidocaine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/041/001", "product_name": "Strepsils Intensive 8.75 mg Lozenges", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2003-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AX", "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/041/004", "product_name": "Strepsils Intensive Orange Sugar Free 8.75mg Lozenges", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AX", "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/041/005", "product_name": "Strepsils Intensive Cherry & Mint 8.75mg/dose Oromucosal Spray", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "R02AX", "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/042/001", "product_name": "Strepsils Extra Blackcurrant Lozenges", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2005-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA12" ], "active_substances": [ "Hexylresorcinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/053/001", "product_name": "Lemsip Multirelief capsules Paracetamol 500mg Phenylephrine hydrochloride 6.1mg Guaifenesin 100mg", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Phenylephrine hydrochloride", "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/056/001", "product_name": "Nurofen for Children Six Plus Orange 200 mg/5 ml oral suspension", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/056/002", "product_name": "Nurofen for Children Six Plus Strawberry 200 mg/5 ml oral suspension", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/060/001", "product_name": "Strepsils Sore Throat & Blocked Nose Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Levomenthol 8.0mg", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1991-01-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "Levomenthol", "2,4-Dichlorobenzyl alcohol" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/065/001", "product_name": "Nurofen Sinus and Pain Film-Coated Tablets Ibuprofen 200mg Pseudoephedrine Hydrochloride 30mg", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2014-06-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/066/001", "product_name": "Nurofen for Children Cold & Flu & Pain Orange 100mg/5ml Oral Suspension", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/067/001", "product_name": "Nurofen for Children Cold & Flu & Pain Strawberry 100mg/5ml Oral Suspension", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/069/001", "product_name": "Nurofen for children 100 mg chewable capsules, Soft", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "2014-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/072/001", "product_name": "Strepsils Intensive Honey and Lemon 8.75mg/dose Oromucosal Spray", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2019-12-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "R02AX", "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/075/001", "product_name": "Nurofen Advance 200 mg Tablets", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen lysinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/077/001", "product_name": "Remegel 800 mg Chewable Tablets", "holder": "Reckitt Benckiser Ireland Ltd", "authorised_date": "1992-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AC", "A02AC01" ], "active_substances": [ "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/079/001", "product_name": "Optrex Clear Eyes Eye Drops Solution Hamamelis Water 12.5% v/v Naphazoline Hydrochloride 0.01% w/v", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GA", "S01GA51" ], "active_substances": [ "Hamamelis water", "Naphazoline hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/080/001", "product_name": "Strepsils Intensive Honey & Eucalyptus Sugar Free 8.75 mg lozenges", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2022-07-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/081/001", "product_name": "Nurofen Long Lasting 300 mg prolonged-release tablets", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2023-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/082/001", "product_name": "Gaviscon Extra Mixed Berries Flavour Chewable Tablets Sodium alginate 250 mg Sodium hydrogen carbonate 106.5 mg Calcium carbonate 187.5 mg", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02BX", "A02BX13" ], "active_substances": [ "Sodium alginate", "Sodium hydrogen carbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/083/001", "product_name": "Gaviscon Extra Mixed Berries Flavour Oral Suspension in Sachet Sodium alginate 500 mg/10ml Sodium hydrogen carbonate 213 mg/ 10ml Calcium carbonate 325 mg/ 10ml", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX" ], "active_substances": [ "Sodium alginate", "Sodium hydrogen carbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/084/001", "product_name": "Gaviscon Extra Mixed Berries Oral Suspension Sodium alginate 500 mg/ 10 ml sodium hydrogen carbonate 213 mg/ 10 ml Calcium carbonate 325 mg/ 10 ml", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02BX" ], "active_substances": [ "Sodium alginate", "Sodium hydrogen carbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/085/001", "product_name": "Nurofen Rapid Relief Max 400 mg soft capsules", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2023-08-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA0979/086/001", "product_name": "Nuromol Dual Action 500/200mg film-coated tablets", "holder": "Reckitt Benckiser Ireland Ltd,", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA0982/001/001", "product_name": "CosmoFer 50mg/ml solution for infusion and injection", "holder": "Pharmacosmos A/S", "authorised_date": "2001-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "Iron (III) hydroxide dextran complex" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA0982/002/001", "product_name": "Monover 100 mg/ml solution for injection/infusion (ampoules)", "holder": "Pharmacosmos A/S", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "Iron" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0982/002/002", "product_name": "Monover 100 mg/ml solution for injection/infusion (vials)", "holder": "Pharmacosmos A/S", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "Iron" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0982/004/001", "product_name": "Diafer 50 mg/ml solution for injection", "holder": "Pharmacosmos A/S", "authorised_date": "2014-05-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B03AC" ], "active_substances": [ "IRON (III)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA0988/003/001", "product_name": "Axhidrox 2.2 mg/pump actuation cream", "holder": "Dr. August Wolff GmbH & Co. KG Arzneimittel", "authorised_date": "2023-03-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D11AA" ], "active_substances": [ "Glycopyrronium bromide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1005/002/001", "product_name": "Onytec 80mg/g medicated nail lacquer", "holder": "Polichem S.A.", "authorised_date": "2012-09-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated nail lacquer", "atc_codes": [ "D01AE", "D01AE14" ], "active_substances": [ "Ciclopirox" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1005/003/001", "product_name": "Finjuve 2.275 mg/ml cutaneous spray, solution", "holder": "Polichem S.A.", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous spray, solution", "atc_codes": [ "D11AX10" ], "active_substances": [ "Finasteride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/001/002", "product_name": "DDAVP/Desmopressin 4 micrograms/ml Solution for Injection", "holder": "Ferring Ireland Ltd", "authorised_date": "1977-02-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "DESMOPRESSIN ACETATE" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/003/001", "product_name": "Picolax 10mg/3.5g/12 g Powder for Oral Solution", "holder": "Ferring Ireland Ltd", "authorised_date": "1983-02-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AB", "A06AB58" ], "active_substances": [ "Sodium picosulfate", "Magnesium oxide, light", "Citric acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/004/001", "product_name": "GLYPRESSIN 1 mg Powder and Solvent for Solution for Injection", "holder": "Ferring Ireland Ltd", "authorised_date": "1987-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "H01BA", "H01BA04" ], "active_substances": [ "Terlipressin acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/004/002", "product_name": "Glypressin 1 mg/ 8.5 ml solution for injection", "holder": "Ferring Ireland Ltd", "authorised_date": "2009-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01BA", "H01BA04" ], "active_substances": [ "Terlipressin acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/001", "product_name": "Pentasa Sachet 1g prolonged-release granules", "holder": "Ferring Ireland Ltd", "authorised_date": "1998-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/002", "product_name": "Pentasa 1g Suppositories", "holder": "Ferring Ireland Ltd", "authorised_date": "1992-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/003", "product_name": "Pentasa 10 mg/ml Rectal Suspension", "holder": "Ferring Ireland Ltd", "authorised_date": "1989-02-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal suspension", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/005", "product_name": "Pentasa 500 mg prolonged-release tablets", "holder": "Ferring Ireland Ltd", "authorised_date": "1992-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/006", "product_name": "Pentasa Sachet 2g prolonged-release granules", "holder": "Ferring Ireland Ltd", "authorised_date": "2007-12-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/007", "product_name": "Pentasa 1 g prolonged-release tablets", "holder": "Ferring Ireland Ltd", "authorised_date": "2011-01-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/006/008", "product_name": "Pentasa Sachet 4 g Prolonged-release granules", "holder": "Ferring Ireland Ltd", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/007/002", "product_name": "Desmotabs Melt 60 micrograms oral lyophilisate", "holder": "Ferring Ireland Ltd", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "Desmopressin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/007/003", "product_name": "Desmotabs Melt 120 micrograms oral lyophilisate", "holder": "Ferring Ireland Ltd", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "Desmopressin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/007/004", "product_name": "Desmotabs Melt 240 micrograms oral lyophilisate", "holder": "Ferring Ireland Ltd", "authorised_date": "2005-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "Desmopressin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/015/002", "product_name": "MENOPUR 600 IU Powder and Solvent for Solution for Injection", "holder": "Ferring Ireland Ltd", "authorised_date": "2011-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA02" ], "active_substances": [ "Menotrophin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/015/003", "product_name": "MENOPUR 1200 IU Powder and Solvent for Solution for Injection", "holder": "Ferring Ireland Ltd", "authorised_date": "2011-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA02" ], "active_substances": [ "Menotrophin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/017/001", "product_name": "Nordurine 0.1 mg Tablets", "holder": "Ferring Ireland Ltd", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "DESMOPRESSIN ACETATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/017/002", "product_name": "Nordurine 0.2 mg Tablets", "holder": "Ferring Ireland Ltd", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "DESMOPRESSIN ACETATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/021/001", "product_name": "Pabal 100 micrograms/ml, solution for injection", "holder": "Ferring Ireland Ltd", "authorised_date": "2006-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01BB", "H01BB03" ], "active_substances": [ "Carbetocin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/022/001", "product_name": "Lutinus 100 mg vaginal tablets", "holder": "Ferring Ireland Ltd", "authorised_date": "2010-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal tablet", "atc_codes": [ "G03DA", "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/026/001", "product_name": "Cortiment 9 mg prolonged release tablets", "holder": "Ferring Ireland Ltd", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EA", "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/027/001", "product_name": "Noqturina 25 microgram oral lyophilisate", "holder": "Ferring Ireland Ltd", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "Desmopressin" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/027/002", "product_name": "Noqturina 50 microgram oral lyophilisate", "holder": "Ferring Ireland Ltd", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "Desmopressin" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/029/001", "product_name": "Propess 10 mg vaginal delivery system", "holder": "Ferring Ireland Ltd", "authorised_date": "2018-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal delivery system", "atc_codes": [ "G02AD", "G02AD02" ], "active_substances": [ "Dinoprostone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/030/001", "product_name": "Menotrophin Ferring 75 IU powder and solvent for solution for injection.", "holder": "Ferring Ireland Ltd", "authorised_date": "2022-10-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA02" ], "active_substances": [ "Menotrophin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/030/002", "product_name": "Menotrophin Ferring 600 IU solution for injection in a pre-filled pen", "holder": "Ferring Ireland Ltd", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA02" ], "active_substances": [ "Menotrophin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1009/030/003", "product_name": "Menotrophin Ferring 1200 IU solution for injection in a pre-filled pen", "holder": "Ferring Ireland Ltd", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "G03GA02" ], "active_substances": [ "Menotrophin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1015/001/001", "product_name": "Grafalon 20 mg/ml concentrate for solution for infusion", "holder": "Neovii Biotech GmbH", "authorised_date": "2001-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AA", "L04AA04" ], "active_substances": [ "Anti-human t-lymphocyte immunoglobulin from rabbits" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/007/001", "product_name": "Bricanyl 500 micrograms/ml solution for injection or infusion", "holder": "AstraZeneca AB", "authorised_date": "1999-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "R03CC", "R03CC03" ], "active_substances": [ "Terbutaline sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/007/002", "product_name": "Bricanyl Turbohaler 500 micrograms per metered dose, inhalation powder", "holder": "AstraZeneca AB", "authorised_date": "1989-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AC", "R03AC03" ], "active_substances": [ "Terbutaline sulfate" ], "routes": [ "Inhalation use", "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/015/001", "product_name": "Oxis Turbohaler 6, inhalation powder", "holder": "AstraZeneca AB", "authorised_date": "2002-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AC", "R03AC13" ], "active_substances": [ "Formoterol fumatrate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/015/002", "product_name": "Oxis Turbohaler 12, inhalation powder", "holder": "AstraZeneca AB", "authorised_date": "2002-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AC", "R03AC13" ], "active_substances": [ "Formoterol fumatrate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/017/001", "product_name": "Pulmicort Respules 0.5 mg/2 ml Nebuliser Suspension", "holder": "AstraZeneca AB", "authorised_date": "2001-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/017/002", "product_name": "Pulmicort Respules 1 mg /2 ml Nebuliser Suspension", "holder": "AstraZeneca AB", "authorised_date": "2001-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/017/003", "product_name": "Pulmicort Turbohaler 100 micrograms Inhalation Powder", "holder": "AstraZeneca AB", "authorised_date": "2002-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/017/004", "product_name": "Pulmicort Turbohaler 200 micrograms Inhalation Powder", "holder": "AstraZeneca AB", "authorised_date": "2000-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/017/005", "product_name": "Pulmicort Turbohaler 400 micrograms Inhalation Powder", "holder": "AstraZeneca AB", "authorised_date": "2000-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03BA", "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/020/001", "product_name": "Symbicort Turbohaler, 100 micrograms /6 micrograms/inhalation, inhalation powder", "holder": "AstraZeneca AB", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/020/002", "product_name": "Symbicort® Turbohaler; 200 micrograms/6 micrograms/inhalation, inhalation powder", "holder": "AstraZeneca AB", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK" ], "active_substances": [ "Budesonide", "Formoterol fumatrate 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1019/027/002", "product_name": "Zoladex LA 10.8 mg implant", "holder": "AstraZeneca AB", "authorised_date": "2001-01-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "L02AE", "L02AE03" ], "active_substances": [ "Goserelin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1024/003/001", "product_name": "Hexvix 85 mg, powder and solvent for intravesical solution", "holder": "Photocure ASA", "authorised_date": "2007-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for intravesical solution", "atc_codes": [ "V04CX" ], "active_substances": [ "Hexaminolevulinate hydrochloride" ], "routes": [ "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/001/001", "product_name": "Dovobet® 50 microgram/g + 0.5 mg/g ointment", "holder": "LEO Pharma A/S", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D05AX", "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/001/002", "product_name": "Dovobet 50 microgram/g + 0.5 mg/g gel", "holder": "LEO Pharma A/S", "authorised_date": "2008-09-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D05AX", "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/002/001", "product_name": "Protamine sulphate LEO Pharma 1400 anti-heparin IU/ml solution for injection and infusion", "holder": "LEO Pharma A/S", "authorised_date": "2006-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AB", "V03AB14" ], "active_substances": [ "Protamine sulphate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/003/001", "product_name": "Xamiol 50 micrograms/g + 0.5 mg/g gel", "holder": "LEO Pharma A/S", "authorised_date": "2008-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D05AX", "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/005/001", "product_name": "Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam", "holder": "LEO Pharma A/S", "authorised_date": "2016-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous foam", "atc_codes": [ "D05AX", "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/009/001", "product_name": "Skinoren 15% Gel", "holder": "LEO Pharma A/S", "authorised_date": "2003-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AX", "D10AX03" ], "active_substances": [ "Azelaic acid" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1025/012/001", "product_name": "Travocort 0.1 + 1% w/w Cream", "holder": "LEO Pharma A/S", "authorised_date": "1981-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC05" ], "active_substances": [ "DIFLUCORTOLONE VALERATE", "Isoconazole nitrate" ], "routes": [ "Cutaneous use", "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1026/001/001", "product_name": "Neupogen 30 MU (0.3 mg/ml) Solution for injection filgrastim", "holder": "Amgen Europe B.V.,", "authorised_date": "1991-06-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1026/001/007", "product_name": "Neupogen Singleject 30 MU/0.5 ml Solution for injection in a pre-filled syringe filgrastim", "holder": "Amgen Europe B.V.,", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1026/001/008", "product_name": "Neupogen Singleject 48 MU/0.5 ml Solution for injection in a pre-filled syringe filgrastim", "holder": "Amgen Europe B.V.,", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AA", "L03AA02" ], "active_substances": [ "Filgrastim" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1032/001/001", "product_name": "Transtec 35 micrograms/h Transdermal Patch", "holder": "Grünenthal GmbH", "authorised_date": "2002-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1032/001/002", "product_name": "Transtec 52.5 micrograms/h Transdermal Patch", "holder": "Grünenthal GmbH", "authorised_date": "2002-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1032/001/003", "product_name": "Transtec 70 micrograms/h Transdermal Patch", "holder": "Grünenthal GmbH", "authorised_date": "2002-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1033/001/001", "product_name": "IDEOS 500mg/400 IU Chewable Tablets", "holder": "Laboratoire Innotech International", "authorised_date": "1996-01-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1034/001/001", "product_name": "PULMOTEC Kit for radiopharmaceutical preparation", "holder": "Cyclomedica Ireland Ltd", "authorised_date": "2000-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09EA", "V09EA02" ], "active_substances": [ "Graphites" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1045/001/001", "product_name": "Citanest with Octapressin Dental, Prilocaine Hydrochloride 3 % w/v, Felypressin 0.54 micrograms/ml Solution for Injection", "holder": "DENTSPLY DeTrey GmbH", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB54" ], "active_substances": [ "Prilocaine hydrochloride", "Felypressin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1045/003/001", "product_name": "Xylocaine 2% w/v with Adrenaline (Epinephrine) 1:80,000 DENTAL Solution for Injection", "holder": "DENTSPLY DeTrey GmbH", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB04" ], "active_substances": [ "Lidocaine hydrochloride", "Adrenaline" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1045/004/001", "product_name": "Oraqix 25/25 mg per g Periodontal gel", "holder": "DENTSPLY DeTrey GmbH", "authorised_date": "2005-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Periodontal gel", "atc_codes": [ "N01BB", "N01BB20" ], "active_substances": [ "Lidocaine", "Prilocaine" ], "routes": [ "Periodontal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/001/002", "product_name": "Androgel 50 mg, transdermal gel in sachet", "holder": "Laboratoires Besins International", "authorised_date": "2003-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal gel in sachet", "atc_codes": [ "G03BA", "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/002/002", "product_name": "Testogel 50 mg transdermal gel in sachet", "holder": "Laboratoires Besins International", "authorised_date": "2003-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal gel in sachet", "atc_codes": [ "G03BA", "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/002/004", "product_name": "Testogel 16.2 mg/g, Gel", "holder": "Laboratoires Besins International", "authorised_date": "2015-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "G03BA", "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/002/005", "product_name": "Testogel 40.5 mg transdermal gel in sachet", "holder": "Laboratoires Besins International", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal gel in sachet", "atc_codes": [ "G03B", "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/003/001", "product_name": "Utrogestan 100 mg capsules, soft", "holder": "Laboratoires Besins International", "authorised_date": "2006-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/004/001", "product_name": "Oestrogel Pump-Pack 750 micrograms/actuation Gel", "holder": "Laboratoires Besins International", "authorised_date": "2006-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "G03CA03" ], "active_substances": [ "Estradiol hemihydrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1054/005/001", "product_name": "IMVAGGIS 0.03 mg pessary", "holder": "Laboratoires Besins International", "authorised_date": "2018-03-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G03CA", "G03CA04" ], "active_substances": [ "Estriol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/001/001", "product_name": "Betnovate Cream 0.1% w/w", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AC", "D07AC01" ], "active_substances": [ "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/001/002", "product_name": "Betnovate Ointment 0.1% w/w", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D07AC", "D07AC01" ], "active_substances": [ "Betamethasone valerate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/001/003", "product_name": "Betnovate Scalp Application 0.1% w/w Cutaneous Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1984-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D07AC", "D07AC01" ], "active_substances": [ "Betamethasone" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/005/001", "product_name": "Dermovate 0.05% w/w Cream", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AD", "D07AD01" ], "active_substances": [ "Clobetasol propionate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/005/002", "product_name": "Dermovate 0.05% w/w Ointment", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D07AD", "D07AD01" ], "active_substances": [ "Clobetasol propionate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/005/003", "product_name": "Dermovate Scalp Application 0.05% w/v Cutaneous Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D07AD", "D07AD01" ], "active_substances": [ "Clobetasol propionate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/006/001", "product_name": "Eumovate Cream 0.05% w/w", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1976-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AB", "D07AB01" ], "active_substances": [ "CLOBETASONE BUTYRATE" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/008/003", "product_name": "Imigran 10 mg Nasal Spray, Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/008/004", "product_name": "Imigran 20 mg nasal spray, solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/008/006", "product_name": "Imigran Ftab 50 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2004-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/008/007", "product_name": "Imigran Ftab 100 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2004-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/011/001", "product_name": "Relenza 5mg/dose, inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-07-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "J05AH01" ], "active_substances": [ "Zanamivir" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/017/001", "product_name": "Zyban 150 mg prolonged release tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06AX", "N06AX12" ], "active_substances": [ "Bupropion hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/019/003", "product_name": "Augmentin 500 mg/125 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/019/005", "product_name": "Augmentin 875 mg/125 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/019/006", "product_name": "Augmentin Duo Mixed Fruit 400 mg/57 mg/5 ml Powder for Oral Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/020/001", "product_name": "Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2001-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AJ52" ], "active_substances": [ "Pertactin", "Filamentous haemagglutinin", "Pertussis toxoid", "Tetanus toxoid", "Diphtheria toxoid" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/023/002", "product_name": "Engerix B 20 micrograms/1 ml Suspension for injection in pre-filled syringe Hepatitis B (rDNA) vaccine (adsorbed) (HBV)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1998-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC01" ], "active_substances": [ "Hepatitis b surface antigen, recominant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/026/001", "product_name": "Havrix Junior Monodose Vaccine. Hepatitis A Vaccine (Inactivated, Adsorbed). 720 ELISA units/ 0.5ml Suspension for injection in a pre-filled syringe", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1998-10-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC02" ], "active_substances": [ "Hepatitis A antigen" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/026/002", "product_name": "Havrix Monodose Vaccine. Hepatitis A Vaccine (inactivated, adsorbed), 1440 ELISA units/ 1ml Suspension for injection in a pre-filled syringe", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1994-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC02" ], "active_substances": [ "Aluminium", "Hepatitis A antigen" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/027/001", "product_name": "Hiberix. Haemophilus Type b (Hib) vaccine.Powder and Solvent for Solution for Injection", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-06-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J07AG51" ], "active_substances": [ "Haemophilus influenzae type b polysaccharide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/036/001", "product_name": "Priorix - Powder and solvent for solution for injection in a pre-filled syringeMeasles, Mumps and Rubella vaccine (live)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection in pre-filled syringe", "atc_codes": [ "J07BD", "J07BD52" ], "active_substances": [ "Measles virus - schwarz strain live attenuated", "Mumps vaccine rit 4385 live attenuated", "Rubella virus (ra 27/3 strain)" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/001", "product_name": "Requip 0.25 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/003", "product_name": "Requip 1 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/004", "product_name": "Requip 2 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/005", "product_name": "Requip 5 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/006", "product_name": "Requip-Modutab 2 mg Prolonged-Release Tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/008", "product_name": "Requip-Modutab 4 mg Prolonged-Release Tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/037/009", "product_name": "Requip-Modutab 8 mg Prolonged-Release Tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/042/006", "product_name": "Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2005-01-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/042/007", "product_name": "Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2005-01-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/042/009", "product_name": "Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2007-01-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/009", "product_name": "Flixotide Diskus 50 micrograms, Inhalation Powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/010", "product_name": "Flixotide Diskus 100 micrograms, Inhalation Powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/011", "product_name": "Flixotide Diskus 250 micrograms, Inhalation Powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/012", "product_name": "Flixotide Diskus 500 micrograms, Inhalation Powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/013", "product_name": "Flixotide Evohaler 50 micrograms per metered dose, Pressurised Inhalation Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2000-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/014", "product_name": "Flixotide Evohaler 125 micrograms per metered dose Pressurised Inhalation Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-01-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/044/015", "product_name": "Flixotide Evohaler 250 micrograms per metered dose Pressurised Inhalation, Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-01-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/046/001", "product_name": "Seretide 100 Diskus 50 microgram/100 microgram/dose inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/046/002", "product_name": "Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/046/003", "product_name": "Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/046/004", "product_name": "Seretide 50 Evohaler 25 microgram/50 microgram/dose pressurised inhalation, suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/046/005", "product_name": "Seretide 125 Evohaler 25 microgram/125 microgram/dose pressurised inhalation, suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/046/006", "product_name": "Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2001-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/047/003", "product_name": "Serevent Diskus, 50 micrograms per metered dose, inhalation powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1997-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AC", "R03AC12" ], "active_substances": [ "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/047/005", "product_name": "Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2006-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AC", "R03AC12" ], "active_substances": [ "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/049/001", "product_name": "Ventolin 500 micrograms/ml Solution for Injection", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1975-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "R03AC", "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/049/002", "product_name": "Ventolin 1mg/ml Concentrate for Solution for Intravenous Infusion", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1975-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "R03CC", "R03CC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/049/010", "product_name": "Ventolin Evohaler 100 micrograms pressurised inhalation, suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AC", "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/049/011", "product_name": "Ventolin Diskus 200 micrograms Inhalation Powder, pre-dispensed", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AC", "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/049/012", "product_name": "Ventolin 2mg/5ml Oral Solution", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1975-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R03CC", "R03CC02" ], "active_substances": [ "SALBUTAMOL SULFATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/058/001", "product_name": "Flolan 1.5 mg powder and solvent for solution for infusion", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2000-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B01AC", "B01AC09" ], "active_substances": [ "Epoprostenol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/058/002", "product_name": "Flolan 0.5 mg powder and solvent for solution for infusion", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1992-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B01AC", "B01AC09" ], "active_substances": [ "Epoprostenol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/001", "product_name": "Lamictal 25 mg tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1990-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/002", "product_name": "Lamictal 50 mg tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1990-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/003", "product_name": "Lamictal 100 mg tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1990-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/004", "product_name": "Lamictal 200 mg tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1994-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/005", "product_name": "Lamictal 2 mg chewable/dispersible tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2001-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/006", "product_name": "Lamictal 5 mg chewable/dispersible tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1994-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/007", "product_name": "Lamictal 25 mg chewable/dispersible tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1994-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/008", "product_name": "Lamictal 50 mg chewable/dispersible tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1997-05-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/009", "product_name": "Lamictal 100 mg chewable/dispersible tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1994-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/061/010", "product_name": "Lamictal 200 mg chewable/dispersible tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1997-05-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/066/001", "product_name": "Lyclear 5% w/w Dermal Cream", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1995-07-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "P03AC", "P03AC04" ], "active_substances": [ "Permethrin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/074/001", "product_name": "Phymet DTF 1 mg/ml Syrup", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N07BC", "N07BC02" ], "active_substances": [ "Methadone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/082/001", "product_name": "Valtrex 250 mg Film-Coated Tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1999-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB11" ], "active_substances": [ "Valaciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/082/002", "product_name": "Valtrex 500mg Film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1994-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB11" ], "active_substances": [ "Valaciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/084/001", "product_name": "Zovirax 5% w/w Cream", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1984-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB03" ], "active_substances": [ "Acyclovir" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/084/003", "product_name": "Zovirax IV for Infusion 250 mg, Powder for solution for infusion", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/084/005", "product_name": "Zovirax 200 mg/5 mL Oral Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1986-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/084/006", "product_name": "Zovirax Double Strength 400 mg/5 mL Oral Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1991-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Acyclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/084/007", "product_name": "Zovirax 200 mg Dispersible Tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/093/004", "product_name": "Augmentin Paediatric 125 mg/31.25 mg per 5 ml Powder for Oral Suspension", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1983-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/093/007", "product_name": "Augmentin 250 mg/125 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1982-09-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/094/001", "product_name": "Bactroban 2% w/w Ointment", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1986-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D06AX", "D06AX09" ], "active_substances": [ "Mupirocin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/094/002", "product_name": "Bactroban 2% w/w Nasal Ointment", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1989-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal ointment", "atc_codes": [ "D06AX", "D06AX09" ], "active_substances": [ "Mupirocin calcium" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/097/002", "product_name": "Seroxat 20 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1991-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB05" ], "active_substances": [ "Paroxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/097/003", "product_name": "Seroxat 30 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "1991-03-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB05" ], "active_substances": [ "Paroxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/097/004", "product_name": "Seroxat 10 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2004-03-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB05" ], "active_substances": [ "Paroxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/101/001", "product_name": "IPV-Boostrix– Suspension for injection in a pre-filled syringeDiphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2004-12-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07CA02" ], "active_substances": [ "Diphtheria toxoid", "Tetanus toxoid", "Pertussis toxoid", "Filamentous haemagglutinin", "Pertactin", "Type 1 (mahoney)", "Type 2 (mef-1)", "Type 3 (saukett)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/104/001", "product_name": "Avodart 0.5 mg soft capsules", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2004-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G04CB", "G04CB02" ], "active_substances": [ "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/108/001", "product_name": "IPV Infanrix suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2005-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07CA02" ], "active_substances": [ "Pertussis toxoid", "Filamentous haemagglutinin", "Pertactin", "Diphtheria toxoid", "Tetanus toxoid", "Polio virus type 1 inactivated", "Polio virus type 2 inactivated", "Polio virus type 3 inactivated" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/111/001", "product_name": "Malarone 250 mg/100 mg film-coated tablets", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2005-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "P01BB", "P01BB51" ], "active_substances": [ "Atovaquone", "PROGUANIL HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/117/001", "product_name": "Priorix-Tetra powder and solvent for solution for injection in pre-filled syringe Measles, mumps, rubella and varicella vaccine (live)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2007-08-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection in pre-filled syringe", "atc_codes": [ "J07BD", "J07BD54" ], "active_substances": [ "Live attenuated measles virus (schwarz strain)", "Live attenuated mumps virus (rit 4385 strain)", "Live attenuated rubella virus (wistar ra 27/3 strain)", "Live attenuated varicella virus (oka strain)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/118/001", "product_name": "Combodart 0.5 mg/ 0.4 mg hard capsules", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2010-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA", "G04CA52" ], "active_substances": [ "Dutasteride", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/120/001", "product_name": "Duac Once Daily 10mg/g + 50mg/g Gel", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2005-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AF", "D10AF51" ], "active_substances": [ "CLINDAMYCIN PHOSPHATE", "Benzoyl peroxide hydrous" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1077/134/001", "product_name": "Fluarix Tetra suspension for injection in pre-filled syringe Influenza vaccine (split virion, inactivated)", "holder": "GlaxoSmithKline (Ireland) Limited", "authorised_date": "2018-06-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB", "J07BB02" ], "active_substances": [ "B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)", "Influenza A virus, subtype H1N1, strain A/Missouri/11/2025 pdm09-like strain (A/Switzerland/6849/2025, IVR-278), Inactivated", "Influenza A virus, subtype H3N2, strain A/Darwin/1454/2025-like strain (A/Michigan/105/2025, SAN-049A), Inactivated", "Influenza B virus, strain B/Tokyo/EIS13-175/2025-like strain (B/Tokyo/EIS13-175/2025, wild type), Inactivated" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1082/004/001", "product_name": "Pemetrexed 25 mg/ml concentrate for solution for infusion", "holder": "BioOrganics BV", "authorised_date": "2018-01-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1099/001/001", "product_name": "Omacor 1000 mg Soft Capsules", "holder": "BASF AS", "authorised_date": "2003-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "C10AX", "C10AX06" ], "active_substances": [ "Omega-3-acid ethyl esters" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/002/001", "product_name": "Fostimon 75 IU, powder and solvent for solution for injection", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA04" ], "active_substances": [ "Urofollitropin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/002/002", "product_name": "Fostimon 150 IU, powder and solvent for solution for injection", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA04" ], "active_substances": [ "Urofollitropin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/002/003", "product_name": "Fostimon PFS 75 IU Powder and Solvent for Solution for Injection", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA04" ], "active_substances": [ "Urofollitropin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/002/004", "product_name": "Fostimon PFS 150 IU Powder and Solvent for Solution for Injection", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA04" ], "active_substances": [ "Urofollitropin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/002/005", "product_name": "Fostimon PFS 225 IU Powder and Solvent for Solution for Injection", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA04" ], "active_substances": [ "Urofollitropin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/002/006", "product_name": "Fostimon PFS 300 IU Powder and Solvent for Solution for Injection", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "G03GA", "G03GA04" ], "active_substances": [ "Urofollitropin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/003/001", "product_name": "Chondromel 400 mg Capsules", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2005-12-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01" ], "active_substances": [ "Chondroitin sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/004/001", "product_name": "Flector Tissugel 140 mg medicated plaster", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2003-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac epolamine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/005/001", "product_name": "Diclofenac 140 mg medicated plaster", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac epolamine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1104/006/001", "product_name": "Lubion 25 mg solution for injection in pre-filled syringe", "holder": "IBSA Farmaceutici Italia S.r.l", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/002/001", "product_name": "LIQUIVISC 2.5 mg/g eye gel", "holder": "Laboratoires Thea", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carbomer" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/003/001", "product_name": "Timofluid 1 mg/g eye gel in single-dose container", "holder": "Laboratoires Thea", "authorised_date": "2010-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel in single-dose container", "atc_codes": [ "S01ED", "S01ED01" ], "active_substances": [ "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/004/001", "product_name": "Azyter 15 mg/g eye drops, solution, in single-dose container", "holder": "Laboratoires Thea", "authorised_date": "2011-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AA", "S01AA26" ], "active_substances": [ "Azithromycin dihydrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/005/001", "product_name": "Dexafree 1mg/ml eye drops, solution in single dose container", "holder": "Laboratoires Thea", "authorised_date": "2012-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01BA", "S01BA01" ], "active_substances": [ "DEXAMETHASONE PHOSPHATE" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/006/001", "product_name": "Aprok 50mg powder for solution for injection", "holder": "Laboratoires Thea", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "S01AA", "S01AA27" ], "active_substances": [ "Cefuroxime Sodium" ], "routes": [ "Intraocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/007/001", "product_name": "Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container", "holder": "Laboratoires Thea", "authorised_date": "2012-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01EE", "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/009/002", "product_name": "Voltarol Ophtha Multidose 1mg/ml Eye Drops Solution", "holder": "Laboratoires Thea", "authorised_date": "2002-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01BC", "S01BC03" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/010/001", "product_name": "Zaditen 0.25 mg/ml, eye drops, solution", "holder": "Laboratoires Thea", "authorised_date": "2000-11-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX08" ], "active_substances": [ "KETOTIFEN FUMARATE" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/012/001", "product_name": "Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection", "holder": "Laboratoires Thea", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01FA", "S01FA56" ], "active_substances": [ "Tropicamide", "Phenylephrine hydrochloride", "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Intraocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/013/001", "product_name": "Zoftacot 3.35 mg/ml eye drops, solution in single-dose container", "holder": "Laboratoires Thea", "authorised_date": "2017-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01BA", "S01BA02" ], "active_substances": [ "Hydrocortisone sodium phosphate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/014/001", "product_name": "Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container", "holder": "Laboratoires Thea", "authorised_date": "2018-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Timolol", "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/019/001", "product_name": "Elymbus 0.1 mg/g eye gel in single-dose container", "holder": "Laboratoires Thea", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel in single-dose container", "atc_codes": [ "S01EE03" ], "active_substances": [ "Bimatoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1107/020/001", "product_name": "Duelym 0.1 mg/g + 1 mg/g eye gel in single dose container", "holder": "Laboratoires Thea", "authorised_date": "2025-11-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye gel in single-dose container", "atc_codes": [ "S01ED51" ], "active_substances": [ "Bimatoprost", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1111/002/001", "product_name": "Esomeprazole Jubilant 20 mg gastro-resistant tablets", "holder": "Jubilant Pharmaceuticals nv", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole magnesium (amorphous)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1111/002/002", "product_name": "Esomeprazole Jubilant 40 mg gastro-resistant tablets", "holder": "Jubilant Pharmaceuticals nv", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole magnesium (amorphous)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/001/001", "product_name": "Prednesol 5mg Tablets", "holder": "Phoenix Labs", "authorised_date": "1978-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/002/001", "product_name": "Etoflam 5% w/w Gel", "holder": "Phoenix Labs", "authorised_date": "1990-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA06" ], "active_substances": [ "Etofenamate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/003/001", "product_name": "DELTACORTRIL ENTERIC 5 mg gastro-resistant tablets", "holder": "Phoenix Labs", "authorised_date": "1977-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "H02AB", "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/003/002", "product_name": "DELTACORTRIL ENTERIC 2.5 mg gastro-resistant tablets", "holder": "Phoenix Labs", "authorised_date": "1977-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "H02AB", "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/004/001", "product_name": "Paracetamol 250mg Suppositories", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/004/002", "product_name": "Paracetamol 500mg Suppositories", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/004/003", "product_name": "Paracetamol 80 mg suppositories", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2012-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/004/004", "product_name": "Paracetamol 125 mg suppositories", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2012-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/005/001", "product_name": "Uniflu with Vitamin C Tablets", "holder": "Phoenix Labs", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet + tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Caffeine", "Diphenhydramine hydrochloride", "Paracetamol", "Phenylephrine hydrochloride", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/006/001", "product_name": "Uniflu Plus with Vitamin C Tablets", "holder": "Phoenix Labs", "authorised_date": "1998-10-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet + tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate", "Diphenhydramine hydrochloride", "Phenylephrine hydrochloride", "Caffeine", "Ascorbic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/007/001", "product_name": "Casacol Expectorant SyrupMethoxyphenamine hydrochloride 20 mg/5 ml Guaiphenesin 100 mg/5 ml Sodium Citrate 200 mg/5 ml", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "1979-05-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA", "R05CA10" ], "active_substances": [ "Methoxyphenamine hydrochloride", "Sodium citrate", "Guaiphenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/008/001", "product_name": "Parvolex 200 mg/ml concentrate for Solution for Infusion", "holder": "Phoenix Labs", "authorised_date": "1993-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "V03AB", "V03AB23" ], "active_substances": [ "Acetylcysteine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/009/001", "product_name": "Vitafen 100mg Film-coated Tablets", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2015-04-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AB", "M01AB16" ], "active_substances": [ "Aceclofenac" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/010/001", "product_name": "Exputex 250mg/5ml Oral Solution", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "1985-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CB", "R05CB03" ], "active_substances": [ "Carbocisteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/011/001", "product_name": "Arthrimel 500 mg Film-Coated Tablets", "holder": "Phoenix Labs", "authorised_date": "2005-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Glucosamine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/011/002", "product_name": "Arthrimel 750mg Film Coated Tablets", "holder": "Phoenix Labs", "authorised_date": "2011-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Glucosamine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/011/003", "product_name": "Arthrimel 1500mg Film Coated Tablets", "holder": "Phoenix Labs", "authorised_date": "2011-07-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Glucosamine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/012/001", "product_name": "Sanomigran 500 microgram Tablets", "holder": "Phoenix Labs", "authorised_date": "1994-09-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "N02CX", "N02CX01" ], "active_substances": [ "Pizotifen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/012/002", "product_name": "Sanomigran 1.5mg Tablets", "holder": "Phoenix Labs", "authorised_date": "1994-09-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "N02CX", "N02CX01" ], "active_substances": [ "Pizotifen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/013/001", "product_name": "Caneclear 150 mg hard capsule", "holder": "Phoenix Labs", "authorised_date": "2012-12-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/014/001", "product_name": "Cetirelief Allergy 10 mg film-coated tablets", "holder": "Phoenix Labs", "authorised_date": "2006-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/015/001", "product_name": "Clareeze Allergy 10 mg Tablets", "holder": "Phoenix Labs", "authorised_date": "2001-08-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/016/001", "product_name": "Orosoothe 0.15% w/v Oromucosal Spray", "holder": "Phoenix Labs", "authorised_date": "2019-03-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oromucosal spray", "atc_codes": [ "A01AD02" ], "active_substances": [ "BENZYDAMINE HYDROCHLORIDE" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/017/001", "product_name": "Warticon 0.15% w/w Cream", "holder": "Phoenix Labs", "authorised_date": "1996-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB04" ], "active_substances": [ "Podophyllotoxin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/018/001", "product_name": "Famvir 125 mg film-coated tablets", "holder": "Phoenix Labs", "authorised_date": "1995-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/018/002", "product_name": "Famvir 250 mg film-coated tablets", "holder": "Phoenix Labs", "authorised_date": "1995-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/018/003", "product_name": "Famvir 500 mg film-coated tablets", "holder": "Phoenix Labs", "authorised_date": "2013-05-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/020/001", "product_name": "Dentinox Cradle Cap Treatment Shampoo, Sodium lauryl ether sulpho-succinate 6% w/w, Sodium lauryl ether sulphate 2.7% w/w", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "1995-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D11AX" ], "active_substances": [ "Sodium laurylether sulfate", "Sodium lauryl ether sulfo succinate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Competence of personnel (Article 23 of Directive No 2010/63/EU)" }, { "licence_number": "PA1113/021/001", "product_name": "Dentinox Infant Colic Drops 21 mg/2.5 ml Oral Suspension", "holder": "Phoenix Labs", "authorised_date": "1983-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A03AX", "A03AX13" ], "active_substances": [ "Dimeticone, activated" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/022/001", "product_name": "Medijel oromucosal gel Lidocaine hydrochloride 0.66% w/w Aminoacridine hydrochloride 0.05% w/w", "holder": "Phoenix Labs", "authorised_date": "1984-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal gel", "atc_codes": [ "D08AA", "N01BB52" ], "active_substances": [ "Aminacrine hydrochloride", "Lignocaine hydrochloride" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/024/001", "product_name": "Anthisan Cream 2% w/w", "holder": "Phoenix Labs", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D04AA", "D04AA02" ], "active_substances": [ "Mepyramine maleate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/025/001", "product_name": "Dioralyte Blackcurrant Powder for Oral Solution", "holder": "Phoenix Labs", "authorised_date": "1992-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A07CA" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Glucose", "Disodium hydrogen citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/025/002", "product_name": "Dioralyte Citrus Powder for Oral Solution", "holder": "Phoenix Labs", "authorised_date": "1992-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A07CA" ], "active_substances": [ "Glucose", "Sodium chloride", "Disodium hydrogen citrate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/026/001", "product_name": "Dioralyte Natural, Powder for oral solution", "holder": "Phoenix Labs", "authorised_date": "1989-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A07CA" ], "active_substances": [ "Glucose", "Sodium chloride", "Potassium chloride", "Disodium hydrogen citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/027/001", "product_name": "Solpadol Caplets 500 mg/30 mg tablets", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "1991-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/027/002", "product_name": "Solpadol 500 mg/30 mg Effervescent Tablets", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "1991-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/028/001", "product_name": "Dioralyte Rebalance Blackcurrant Powder for Oral Solution", "holder": "Phoenix Labs", "authorised_date": "2020-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A07CA" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Glucose", "Disodium hydrogen citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/028/002", "product_name": "Dioralyte Rebalance Citrus Powder for Oral Solution", "holder": "Phoenix Labs", "authorised_date": "2020-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A07CA" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Glucose", "Disodium hydrogen citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/028/003", "product_name": "Dioralyte Rebalance Natural Powder for Oral Solution", "holder": "Phoenix Labs", "authorised_date": "2020-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A07CA" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Glucose", "Disodium hydrogen citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/029/001", "product_name": "Proctosedyl Ointment", "holder": "Phoenix Labs", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "C05AA", "C05AA01" ], "active_substances": [ "Hydrocortisone", "Cinchocaine Hydrochloride", "Aesculin", "Framycetin sulphate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1113/030/001", "product_name": "Diprobase Cream", "holder": "Phoenix Labs", "authorised_date": "1983-10-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AC" ], "active_substances": [], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/031/001", "product_name": "Hydroxy-Vit 1000 microgram/ml solution for injection", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2023-03-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B03BA03" ], "active_substances": [ "Hydroxocobalamin chloride" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/032/001", "product_name": "Combileve 500 mg/200 mg film-coated tablets", "holder": "Phoenix Labs", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/033/001", "product_name": "Priligy 30 mg film-coated tablets", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2012-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BX", "G04BX14" ], "active_substances": [ "Dapoxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/033/002", "product_name": "Priligy 60 mg film-coated tablets", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2012-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BX", "G04BX14" ], "active_substances": [ "Dapoxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/034/001", "product_name": "Etoflam 10% w/w gel", "holder": "Phoenix Labs", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA06" ], "active_substances": [ "Etofenamate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/036/001", "product_name": "Actiq 200 micrograms compressed lozenge with integral oromucosal applicator", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2002-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1113/036/002", "product_name": "Actiq 400 micrograms compressed lozenge with integral oromucosal applicator", "holder": "Phoenix Labs Unlimited Company", "authorised_date": "2002-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC07" ], "active_substances": [ "FROVATRIPTAN" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1121/003/001", "product_name": "Paracetamol Banner 500 mg soft capsules", "holder": "Banner Pharmacaps Europe B.V.", "authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/001/001", "product_name": "Water for Injections Ph Eur", "holder": "Noridem Enterprises Limited", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for parenteral use", "atc_codes": [ "V07AB" ], "active_substances": [ "Water for injections" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/002/001", "product_name": "Sodium Chloride 0.9% w/v Injection BP", "holder": "Noridem Enterprises Limited", "authorised_date": "2008-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for parenteral use", "atc_codes": [ "V07AB" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/003/001", "product_name": "Potassium Chloride 15% w/v Concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2008-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA01" ], "active_substances": [ "Potassium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/004/001", "product_name": "Ondansetron 2 mg/ml Solution for Injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2008-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/005/001", "product_name": "Ciprofloxacin 2 mg/ml Solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2008-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/006/001", "product_name": "Fluconazole 2 mg/mL Solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2010-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/008/001", "product_name": "Vancomycin 500 mg Powder for concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/008/002", "product_name": "Vancomycin 1000 mg Powder for concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/009/001", "product_name": "Teicoplanin 200 mg Powder and Solvent for Solution for injection/infusion or oral solution", "holder": "Noridem Enterprises Limited", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "J01XA", "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/009/002", "product_name": "Teicoplanin 400 mg Powder and Solvent for Solution for injection/infusion or oral solution", "holder": "Noridem Enterprises Limited", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "J01XA", "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/011/001", "product_name": "Pantoprazole Noridem 40 mg Powder for Solution for Injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/012/001", "product_name": "Piperacillin/Tazobactam 2g/0.25g powder for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-11-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin sodium", "Tazobactam sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/012/002", "product_name": "Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-11-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin sodium", "Tazobactam sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/013/001", "product_name": "Levofloxacin 5 mg/ml solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2012-07-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA12" ], "active_substances": [ "Levofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/014/001", "product_name": "Remifentanil Noridem 1 mg powder for concentrate for solution for injection or infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-12-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/014/002", "product_name": "Remifentanil Noridem 2 mg powder for concentrate for solution for injection or infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/014/003", "product_name": "Remifentanil Noridem 5 mg powder for concentrate for solution for injection or infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2011-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/015/001", "product_name": "Meropenem 500mg Powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/015/002", "product_name": "Meropenem 1g Powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/016/001", "product_name": "Zoledronic Acid 4 mg/5 ml Concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "M05BA", "M05BA08" ], "active_substances": [ "Zoledronic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/017/001", "product_name": "Cisatracurium 2 mg/ml solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2013-07-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC11" ], "active_substances": [ "Cisatracurium" ], "routes": [ "Intravenous 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solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD01" ], "active_substances": [ "Cefotaxime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/019/002", "product_name": "Cefotaxime 1 g powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD01" ], "active_substances": [ "Cefotaxime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/019/003", "product_name": "Cefotaxime 2 g powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD01" ], "active_substances": [ "Cefotaxime" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/020/001", "product_name": "Dexamethasone phosphate Noridem 4 mg/mL Solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-05-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Intraarticular use", "Intralesional use", "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/021/001", "product_name": "Daptomycin Noridem 350 mg Powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2020-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX", "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/021/002", "product_name": "Daptomycin Noridem 500 mg Powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2020-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX", "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/022/001", "product_name": "Rocuronium bromide 10 mg/mL Solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2020-01-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/023/001", "product_name": "Gentamicin 20 mg/mL solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB03" ], "active_substances": [ "Gentamicin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/023/002", "product_name": "Gentamicin 40 mg/mL solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB03" ], "active_substances": [ "Gentamicin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/023/003", "product_name": "Gentamicin 80 mg/mL solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB03" ], "active_substances": [ "Gentamicin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/024/001", "product_name": "Brodilaten 1.25 mg/2.5 ml Nebuliser solution", "holder": "Noridem Enterprises Limited", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/024/002", "product_name": "Brodilaten 2.5 mg/2.5 ml nebuliser solution", "holder": "Noridem Enterprises Limited", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AC", "R03AC03" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/024/003", "product_name": "Brodilaten 5.0 mg/2.5 ml Nebuliser solution", "holder": "Noridem Enterprises Limited", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AC", "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/025/001", "product_name": "Clarithromycin 500 mg Powder for concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2019-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01FA09" ], "active_substances": [ "Clarithromycin lactobionate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/026/001", "product_name": "Levetiracetam 100 mg/ml Concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/027/001", "product_name": "Lidocaine hydrochloride Noridem 10 mg/ml (1 % w/v) solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Intradermal use", "Intramuscular use", "Intravenous use", "Perineural use", "Subcutaneous use", "Submucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/027/002", "product_name": "Lidocaine hydrochloride Noridem 20 mg/ml (2 % w/v) solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Intradermal use", "Intramuscular use", "Intravenous use", "Perineural use", "Subcutaneous use", "Submucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/028/001", "product_name": "Parecoxib 40 mg powder and solvent for solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "M01AH04" ], "active_substances": [ "Parecoxib Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/028/002", "product_name": "Parecoxib 40 mg powder for solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M01AH04" ], "active_substances": [ "Parecoxib Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/029/001", "product_name": "Bupivacaine 2.5 mg/ml Solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-05-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride, anhydrous" ], "routes": [ "Epidural use", "Infiltration", "Intraarticular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/029/002", "product_name": "Bupivacaine 5 mg/ml Solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2021-05-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride, anhydrous" ], "routes": [ "Epidural use", "Infiltration", "Intraarticular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/030/001", "product_name": "Colistimethate sodium 1 million IU Powder for nebuliser solution", "holder": "Noridem Enterprises Limited", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for nebuliser solution", "atc_codes": [ "J01XB01" ], "active_substances": [ "Colistimethate sodium" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/030/002", "product_name": "Colistimethate sodium 2 million IU Powder for nebuliser 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"Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/031/002", "product_name": "Colistimethate sodium 2 million IU Powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2023-06-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XB01" ], "active_substances": [ "Colistimethate sodium" ], "routes": [ "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/032/001", "product_name": "Sugammadex 100 mg/ml Solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/033/001", "product_name": "Clindamycin 150 mg/ml Solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2023-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01FF01" ], "active_substances": [ "CLINDAMYCIN PHOSPHATE" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/034/001", "product_name": "Amikacin 125 mg/ml Solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB06" ], "active_substances": [ "AMIKACIN SULFATE" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/034/002", "product_name": "Amikacin 250 mg/ml Solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB06" ], "active_substances": [ "AMIKACIN SULFATE" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/035/001", "product_name": "Tigecycline 50 mg Powder for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01AA12" ], "active_substances": [ "Tigecycline" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/036/001", "product_name": "Flucloxacillin 500 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "Flucloxacillin sodium monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/036/002", "product_name": "Flucloxacillin 1000 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "Flucloxacillin sodium monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/036/003", "product_name": "Flucloxacillin 2000 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for 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to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/038/001", "product_name": "Benzylpenicillin sodium 600 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/038/002", "product_name": "Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/038/003", "product_name": "Benzylpenicillin sodium 3000 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/038/004", "product_name": "Benzylpenicillin sodium 6000 mg powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/039/001", "product_name": "Notecor solution for peritoneal dialysis", "holder": "Noridem Enterprises Limited", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DA" ], "active_substances": [ "Icodextrin", "Sodium chloride", "Sodium (S) - lactate", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/040/001", "product_name": "Ziremilon 200 mg/ml emulsion for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA02" ], "active_substances": [ "Refined olive oil", "Fish oil, rich in omega-3 acids", "Refined soyabean oil", "Medium chain triglycerides" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/041/001", "product_name": "Metronidazole 5 mg/mL solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-12-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01XD01" ], "active_substances": [ "Metronidazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/042/001", "product_name": "Metoclopramide hydrochloride 5 mg/ml solution for injection", "holder": "Noridem Enterprises Limited", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A03FA01" ], "active_substances": [ "Metoclopramide hydrochloride monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/043/001", "product_name": "Aciclovir 250 mg powder for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/043/002", "product_name": "Aciclovir 500 mg powder for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/048/001", "product_name": "Dexmedetomidine 100 microgram/ml concentrate for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2026-05-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N05CM18" ], "active_substances": [ "Dexmedetomidine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/051/001", "product_name": "Voriconazole 200 mg powder for solution for infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1122/054/001", "product_name": "Ceftriaxone 1g powder for solution for injection/infusion", "holder": "Noridem Enterprises Limited", "authorised_date": "2026-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1125/002/001", "product_name": "ERtracER Solution for Injection", "holder": "Curium Pharma Ireland Limited", "authorised_date": "2015-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V09IX", "V09IX04" ], "active_substances": [ "Fludeoxyglucose [18F]" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1129/001/001", "product_name": "Rupafin 10mg tablets", "holder": "J. Uriach y Compania S.A.", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX28" ], "active_substances": [ "Rupatadine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1129/001/002", "product_name": "Rupafin 1 mg/ml oral solution", "holder": "J. Uriach y Compania S.A.", "authorised_date": "2012-03-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AX", "R06AX28" ], "active_substances": [ "Rupatadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1131/001/001", "product_name": "Selesyn 100 micrograms/2 ml, oral solution (50 micrograms/ml)", "holder": "biosyn Arzneimittel GmbH", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A12CE", "A12CE02" ], "active_substances": [ "Sodium selenite pentahydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1131/001/002", "product_name": "Selesyn 500 micrograms/10 ml, oral solution (50 micrograms/ml)", "holder": "biosyn Arzneimittel GmbH", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A12CE", "A12CE02" ], "active_substances": [ "Sodium selenite pentahydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1131/001/003", "product_name": "Selesyn 100 micrograms/2 ml, solution for injection (50 micrograms/ml)", "holder": "biosyn Arzneimittel GmbH", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A12CE", "A12CE02" ], "active_substances": [ "Sodium selenite pentahydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1131/001/004", "product_name": "Selesyn 500 micrograms/10 ml, solution for injection (50 micrograms/ml)", "holder": "biosyn Arzneimittel GmbH", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A12CE", "A12CE02" ], "active_substances": [ "Sodium selenite pentahydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/001/001", "product_name": "Valoid 50 mg/ml Solution for Injection", "holder": "Amdipharm Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "R06AE", "R06AE03" ], "active_substances": [ "Cyclizine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/001/002", "product_name": "Valoid 50 mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AE", "R06AE03" ], "active_substances": [ "CYCLIZINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/002/001", "product_name": "NeoMercazole 5 mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1995-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BB", "H03BB01" ], "active_substances": [ "Carbimazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/002/002", "product_name": "NeoMercazole 20 mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1995-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BB", "H03BB01" ], "active_substances": [ "Carbimazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/003/001", "product_name": "Cyclimorph 10 solution for injection", "holder": "Amdipharm Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA51" ], "active_substances": [ "CYCLIZINE TARTRATE", "Morphine tartrate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/003/002", "product_name": "Cyclimorph 15 Solution for Injection", "holder": "Amdipharm Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA", "N02AA51" ], "active_substances": [ "Morphine Tartrate BPC 1959", "CYCLIZINE TARTRATE" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/005/001", "product_name": "Hytrin 1mg and 2mg Tablets (Starter Pack)", "holder": "Amdipharm Limited", "authorised_date": "1989-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04CA", "G04CA03" ], "active_substances": [ "Terazosin", "Terazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/005/002", "product_name": "Hytrin 2mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1989-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04CA", "G04CA03" ], "active_substances": [ "Terazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/005/003", "product_name": "Hytrin 5mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1989-05-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04CA", "G04CA03" ], "active_substances": [ "Terazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/005/004", "product_name": "Hytrin 10mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1989-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04CA", "G04CA03" ], "active_substances": [ "Terazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/006/001", "product_name": "Erythroped SF 250 mg/5 ml granules for oral suspension", "holder": "Amdipharm Limited", "authorised_date": "1999-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/006/002", "product_name": "Erythroped PI SF 125 mg/5 ml granules for oral suspension", "holder": "Amdipharm Limited", "authorised_date": "1999-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/006/004", "product_name": "Erythroped Adult 500mg Film-coated Tablets", "holder": "Amdipharm Limited", "authorised_date": "1986-01-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/008/001", "product_name": "Erythrocin IV Lactobionate 1 g Powder for Concentrate for Solution for Infusion", "holder": "Amdipharm Limited", "authorised_date": "1980-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/008/002", "product_name": "Erythrocin 250 mg tablets", "holder": "Amdipharm Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/008/003", "product_name": "Erythrocin 500 mg tablets", "holder": "Amdipharm Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA01" ], "active_substances": [ "Erythromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/011/001", "product_name": "Maxolon 5 mg/ml Solution for Injection", "holder": "Amdipharm Limited", "authorised_date": "1994-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A03FA", "A03FA01" ], "active_substances": [ "Metoclopramide hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/011/003", "product_name": "Maxolon 10 mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A03FA", "A03FA01" ], "active_substances": [ "Metoclopramide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/013/001", "product_name": "Genticin 80 mg/2ml Solution for Injection", "holder": "Amdipharm Limited", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J01GB", "J01GB03" ], "active_substances": [ "Gentamicin sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/013/002", "product_name": "Genticin 0.3% w/v Eye/Ear Drops, Solution", "holder": "Amdipharm Limited", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear/eye drops, solution", "atc_codes": [ "S02AA", "S02AA14" ], "active_substances": [ "Gentamicin sulfate" ], "routes": [ "Auricular use", "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/014/001", "product_name": "Gentisone HC 0.3% w/v & 1.0% w/v Ear Drops, Suspension", "holder": "Amdipharm Limited", "authorised_date": "1995-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear drops, suspension", "atc_codes": [ "S02CA", "S02CA03" ], "active_substances": [ "Gentamicin sulfate", "HYDROCORTISONE ACETATE" ], "routes": [ "Auricular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/016/001", "product_name": "Fucithalmic 10 mg/g Viscous Eye Drops, suspension", "holder": "Amdipharm Limited", "authorised_date": "1988-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01AA", "S01AA13" ], "active_substances": [ "Fusidic acid hemihydrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/018/001", "product_name": "Ursodeoxycholic Acid 250 mg capsules, hard", "holder": "Amdipharm Limited", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/020/001", "product_name": "Diamox SR 250mg Modified Release Hard Capsules", "holder": "Amdipharm Limited", "authorised_date": "1992-03-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "S01EC", "S01EC01" ], "active_substances": [ "Acetazolamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/020/003", "product_name": "Diamox 250 mg Tablets", "holder": "Amdipharm Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "S01EC", "S01EC01" ], "active_substances": [ "Acetazolamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/021/001", "product_name": "Chloromycetin 0.5% w/v Redidrops eye drops, solution", "holder": "Amdipharm Limited", "authorised_date": "1974-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AA", "S01AA01" ], "active_substances": [ "Chloramphenicol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/022/001", "product_name": "Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion", "holder": "Amdipharm Limited", "authorised_date": "2010-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/023/002", "product_name": "Codipar 15 mg/ 500 mg Capsules", "holder": "Amdipharm Limited", "authorised_date": "2012-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/025/001", "product_name": "Traxam 3 % w/w Gel", "holder": "Amdipharm Limited", "authorised_date": "1987-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA08" ], "active_substances": [ "Felbinac" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/026/001", "product_name": "Phorpain 5% w/w gel", "holder": "Amdipharm Limited", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA13" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/028/001", "product_name": "Eltroxin 50 microgram Tablets", "holder": "Amdipharm Limited", "authorised_date": "1995-09-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/028/002", "product_name": "Eltroxin 100 microgram Tablets", "holder": "Amdipharm Limited", "authorised_date": "1995-09-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/029/001", "product_name": "Eltroxin 25 microgram Tablets", "holder": "Amdipharm Limited", "authorised_date": "2004-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/029/002", "product_name": "Levothyroxine 25 micrograms per 5 ml oral solution", "holder": "Amdipharm Limited", "authorised_date": "2012-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/029/003", "product_name": "Levothyroxine 50 micrograms per 5 ml oral solution", "holder": "Amdipharm Limited", "authorised_date": "2012-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/029/004", "product_name": "Levothyroxine 100 micrograms per 5 ml oral solution", "holder": "Amdipharm Limited", "authorised_date": "2012-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/031/001", "product_name": "Macrodantin 50 mg hard capsules", "holder": "Amdipharm Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XE", "J01XE01" ], "active_substances": [ "Nitrofurantoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/031/002", "product_name": "Macrodantin 100 mg hard capsules", "holder": "Amdipharm Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XE", "J01XE01" ], "active_substances": [ "Nitrofurantoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/033/001", "product_name": "MacroBID 100mg Prolonged-Release Capsules", "holder": "Amdipharm Limited", "authorised_date": "1994-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "J01XE", "J01XE01" ], "active_substances": [ "Nitrofurantoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/034/001", "product_name": "Prednisolone 5 mg soluble tablets", "holder": "Amdipharm Limited", "authorised_date": "2014-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "H02AB", "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/035/001", "product_name": "Parnate 10 mg coated tablets", "holder": "Amdipharm Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "N06AF", "N06AF04" ], "active_substances": [ "Tranylcypromine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/037/001", "product_name": "Stelazine 1mg Film-coated Tablets", "holder": "Amdipharm Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AB", "N05AB06" ], "active_substances": [ "Trifluoperazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/037/002", "product_name": "Stelazine 5 mg film-coated tablets", "holder": "Amdipharm Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AB", "N05AB06" ], "active_substances": [ "Trifluoperazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/039/001", "product_name": "Myrelez 60 mg solution for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2021-07-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/039/002", "product_name": "Myrelez 90 mg solution for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2021-07-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/039/003", "product_name": "Myrelez 120 mg solution for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2021-07-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/040/001", "product_name": "Palmeux 25 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/040/002", "product_name": "Palmeux 50 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/040/003", "product_name": "Palmeux 75 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/040/004", "product_name": "Palmeux 100 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/040/005", "product_name": "Palmeux 150 mg prolonged-release suspension for injection in pre-filled syringe", "holder": "Amdipharm Limited", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "N05AX13" ], "active_substances": [ "Paliperidone palmitate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/041/001", "product_name": "Claforan Powder for Solution for Injection 500mg", "holder": "Amdipharm Limited", "authorised_date": "1981-05-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DD", "J01DD01" ], "active_substances": [ "Cefotaxime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/041/002", "product_name": "Claforan Powder for Solution for Injection 1g", "holder": "Amdipharm Limited", "authorised_date": "1981-05-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DD", "J01DD01" ], "active_substances": [ "Cefotaxime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/042/001", "product_name": "Suprax 200 mg Film-coated Tablets", "holder": "Amdipharm Limited", "authorised_date": "1989-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DD", "J01DD08" ], "active_substances": [ "Cefixime" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/043/001", "product_name": "Famotidine 20 mg film-coated tablets", "holder": "Amdipharm Limited", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1142/043/002", "product_name": "Famotidine 40 mg film-coated tablets", "holder": "Amdipharm Limited", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1166/002/001", "product_name": "NORLEVO® 1.5 mg tablet", "holder": "Laboratoire HRA Pharma", "authorised_date": "2005-08-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AD", "G03AD01" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1178/021/001", "product_name": "Bilhista 20 mg tablets", "holder": "Alfred E Tiefenbacher (GmbH & Co. KG)", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX29" ], "active_substances": [ "Bilastine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/001/001", "product_name": "Abidec Multivitamin Oral Drops Solution", "holder": "Chefaro Ireland DAC", "authorised_date": "2000-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "A11BA" ], "active_substances": [ "Ergocalciferol", "Thiamine hydrochloride", "Riboflavin sodium phosphate", "Pyridoxine hydrochloride", "Nicotinamide", "Ascorbic acid", "Vitamin a palmitate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/003/001", "product_name": "Lyclear Creme Rinse 1% w/w Cutaneous solution", "holder": "Chefaro Ireland DAC", "authorised_date": "1995-07-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "P03AC", "P03AC04" ], "active_substances": [ "Permethrin" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/006/001", "product_name": "Veganin Plus Tablets", "holder": "Chefaro Ireland DAC", "authorised_date": "2002-09-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Caffeine", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/008/001", "product_name": "Beconase Hayfever nasal spray 50 micrograms per spray", "holder": "Chefaro Ireland DAC,", "authorised_date": "1999-09-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/009/001", "product_name": "Paracetamol 500 mg Film-Coated Tablets", "holder": "Chefaro Ireland DAC", "authorised_date": "1992-08-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/010/001", "product_name": "Milk of Magnesia Traditional Mint Flavoured Liquid, 415 mg/5 ml oral suspension", "holder": "Chefaro Ireland DAC,", "authorised_date": "1992-08-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02AA04" ], "active_substances": [ "Magnesium hydroxide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/011/001", "product_name": "Solpadeine Soluble Tablets Paracetamol 500mg Codeine Phosphate Hemihydrate 8mg Caffeine 30mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/011/002", "product_name": "Solpadeine Capsules, Paracetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "1992-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/011/003", "product_name": "Solpadeine TabletsParacetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg", "holder": "Chefaro Ireland DAC", "authorised_date": "1993-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/011/004", "product_name": "Solpa-Plus with Caffeine Soluble Tablets Paracetamol 500 mg Codeine Phosphate Hemihydrate 12.8 mg Caffeine 30 mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/011/005", "product_name": "Solpa-Plus Tablets Paracetamol 500 mg Codeine Phosphate Hemihydrate 12.8 mg", "holder": "Chefaro Ireland DAC", "authorised_date": "2017-03-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/012/001", "product_name": "Solpa-Sinus Film-coated Tablets Paracetamol 500mg Pseudoephedrine Hydrochloride 30mg", "holder": "Chefaro Ireland DAC", "authorised_date": "2003-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/014/001", "product_name": "Tiger Balm Red Ointment", "holder": "Chefaro Ireland DAC", "authorised_date": "1991-10-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "M02A" ], "active_substances": [ "Camphor", "Menthol", "Cajuput oil", "Clove oil" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/014/002", "product_name": "Tiger Balm White Ointment", "holder": "Chefaro Ireland DAC", "authorised_date": "1999-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "M02A" ], "active_substances": [ "Camphor", "Levomenthol", "Cajuput oil", "Clove oil" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/016/001", "product_name": "Nytol One-A-Night 50 mg Tablets", "holder": "Chefaro Ireland DAC,", "authorised_date": "2017-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AA", "R06AA02" ], "active_substances": [ "Diphenhydramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/017/001", "product_name": "Solpa-Extra 500 mg/65 mg Soluble Tablets", "holder": "Chefaro Ireland DAC,", "authorised_date": "2017-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Caffeine", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/001", "product_name": "NiQuitin 7 mg/24 hrs transdermal patches", "holder": "Chefaro Ireland DAC,", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/002", "product_name": "NiQuitin 14 mg/24 hrs transdermal patches", "holder": "Chefaro Ireland DAC,", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/003", "product_name": "NiQuitin 21 mg/24 hrs transdermal patches", "holder": "Chefaro Ireland DAC,", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/004", "product_name": "NiQuitin CLEAR 7 mg/24 hrs transdermal patch", "holder": "Chefaro Ireland DAC,", "authorised_date": "2002-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/005", "product_name": "NiQuitin CLEAR 14 mg/24 hrs transdermal patch", "holder": "Chefaro Ireland DAC,", "authorised_date": "2002-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/006", "product_name": "NiQuitin CLEAR 21 mg/24 hrs transdermal patch", "holder": "Chefaro Ireland DAC,", "authorised_date": "2002-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/007", "product_name": "NiQuitin 2mg Lozenge", "holder": "Chefaro Ireland DAC,", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/008", "product_name": "NiQuitin 4 mg Lozenge", "holder": "Chefaro Ireland DAC,", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/011", "product_name": "Niquitin mini 1.5mg mint lozenges", "holder": "Chefaro Ireland DAC,", "authorised_date": "2009-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/012", "product_name": "Niquitin mini 4mg mint lozenges", "holder": "Chefaro Ireland DAC,", "authorised_date": "2009-05-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/017", "product_name": "Niquitin Mini 2 mg Mint Lozenges", "holder": "Chefaro Ireland DAC,", "authorised_date": "2021-07-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine resinate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/018", "product_name": "Niquitin Mini 2 mg citrus lozenges", "holder": "Chefaro Ireland DAC,", "authorised_date": "2021-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine resinate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/018/019", "product_name": "Niquitin Mini 4 mg citrus lozenges", "holder": "Chefaro Ireland DAC,", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine resinate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/019/001", "product_name": "NiQuitin Fresh Mint 2mg Medicated Chewing Gum", "holder": "Chefaro Ireland DAC", "authorised_date": "2015-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine resinate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/019/002", "product_name": "NiQuitin Fresh Mint 4mg Medicated Chewing Gum", "holder": "Chefaro Ireland DAC", "authorised_date": "2015-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/020/001", "product_name": "Vectavir Cold Sore Cream", "holder": "Chefaro Ireland DAC,", "authorised_date": "2001-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB", "D06BB06" ], "active_substances": [ "Penciclovir" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/021/001", "product_name": "Perrigo Cold & Flu Tablets Paracetamol 250 mg Guaifenesin 100 mg Phenylephrine hydrochloride 5 mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "2010-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Phenylephrine hydrochloride", "Guaifenesin", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/021/002", "product_name": "Solpa Cold & Flu Multi-Relief Capsules Paracetamol 500mg,Guaifenesin 100mg,Phenylephrine hydrochloride 6.1mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "2009-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Phenylephrine hydrochloride", "Guaifenesin", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/021/003", "product_name": "Solpa Cold & Flu Multi-Relief Max Powder for Oral Solution\t\tParacetamol 1000 mg, Guaifenesin 200 mg, Phenylephrine hydrochloride 12.2 mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "2009-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Guaifenesin", "Phenylephrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/022/001", "product_name": "Ibuprofen 200mg Coated Tablets", "holder": "Chefaro Ireland DAC,", "authorised_date": "2013-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/022/002", "product_name": "Ibuprofen Max 400mg Film-coated Tablets", "holder": "Chefaro Ireland DAC,", "authorised_date": "2013-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/023/001", "product_name": "Perrigo Cold & Flu powder for oral solution Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine hydrochloride 10 mg", "holder": "Chefaro Ireland DAC,", "authorised_date": "2018-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Guaifenesin", "Phenylephrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/025/001", "product_name": "Paracetamol 500 mg/Guaifenesin 100 mg/Phenylephrine hydrochloride 6.1 mg capsules, hard", "holder": "Chefaro Ireland DAC,", "authorised_date": "2021-09-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Guaifenesin", "Phenylephrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/026/001", "product_name": "Solpa-Extra Tablets Paracetamol 500 mg Caffeine 65 mg", "holder": "Chefaro Ireland DAC", "authorised_date": "2013-05-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1186/027/001", "product_name": "Esomeprazole 20 mg hard gastro-resistant capsules", "holder": "Chefaro Ireland DAC", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1205/001/001", "product_name": "Prevora 100 mg/ml Dental Solution", "holder": "CHX Technologies Europe Limited", "authorised_date": "2006-05-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Dental solution", "atc_codes": [ "A01AB", "A01AB03" ], "active_substances": [ "CHLORHEXIDINE DIACETATE" ], "routes": [ "Dental use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/002/001", "product_name": "Truoxin I.V. 200mg/100ml solution for infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2007-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/002/002", "product_name": "Truoxin I.V. 400 mg/200 ml solution for infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2008-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/005/001", "product_name": "Imipenem/Cilastatin 500 mg/500 mg powder for solution for infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2010-12-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01DH", "J01DH51" ], "active_substances": [ "Imipenem monohydrate", "Cilastatin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/006/003", "product_name": "Meropenem 2 g powder for solution for injection/infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2022-11-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/008/001", "product_name": "Levofloxacin 5 mg/ml solution for infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA12" ], "active_substances": [ "Levofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/008/002", "product_name": "Levofloxacin 5 mg/ml solution for infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Not 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"Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/009/002", "product_name": "Vancomycin 1000 mg Powder for concentrate for solution for infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2013-01-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/010/001", "product_name": "Teicoplanin Hikma 200 mg Powder for solution for injection/infusion or oral solution", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2018-04-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XA", "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/010/002", "product_name": "Teicoplanin Hikma 400 mg Powder for solution for injection/infusion or oral solution", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2018-04-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XA", "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/010/003", "product_name": "Teicoplanin Hikma 100 mg powder for solution for injection/infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/011/001", "product_name": "Atracurium 10 mg/ml solution for injection/infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC04" ], "active_substances": [ "Atracurium besilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/012/001", "product_name": "Ceftazidime 500 mg powder for solution for injection", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/012/002", "product_name": "Ceftazidime 1 g powder for solution for injection/infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1217/012/003", "product_name": "Ceftazidime 2 g powder for solution for injection/infusion", "holder": "Hikma Farmacêutica (Portugal) S.A.", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/001/002", "product_name": "Distaclor 125 mg/5 ml Granules for Oral Suspension", "holder": "Flynn Pharma Limited", "authorised_date": "1998-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01DC", "J01DC04" ], "active_substances": [ "Cefaclor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/001/003", "product_name": "Distaclor 250 mg/5 ml Granules for Oral Suspension", "holder": "Flynn Pharma Limited", "authorised_date": "1998-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01DC", "J01DC04" ], "active_substances": [ "Cefaclor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/001/004", "product_name": "Distaclor LA 375 mg prolonged-release tablets", "holder": "Flynn Pharma Limited", "authorised_date": "1994-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "J01DC", "J01DC04" ], "active_substances": [ "Cefaclor monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/001/005", "product_name": "Distaclor LA Forte 500 mg prolonged-release tablets", "holder": "Flynn Pharma Limited", "authorised_date": "1994-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "J01DC", "J01DC04" ], "active_substances": [ "Cefaclor monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/002/001", "product_name": "Keflex 250 mg Hard Capsules", "holder": "Flynn Pharma Limited", "authorised_date": "1977-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01DB", "J01DB01" ], "active_substances": [ "Cefalexin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/002/002", "product_name": "Keflex 125 mg/5 ml Powder for Oral Suspension", "holder": "Flynn Pharma Limited", "authorised_date": "1977-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01DB", "J01DB01" ], "active_substances": [ "Cephalexin monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/002/003", "product_name": "Keflex 250 mg/5 ml Powder for Oral Suspension", "holder": "Flynn Pharma Limited", "authorised_date": "1977-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01DB", "J01DB01" ], "active_substances": [ "Cefalexin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/002/004", "product_name": "Keflex 500 mg Film-Coated Tablets", "holder": "Flynn Pharma Limited", "authorised_date": "1977-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DB", "J01DB01" ], "active_substances": [ "Cefalexin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/005/001", "product_name": "Vancocin Matrigel 125mg Hard Capsules", "holder": "Flynn Pharma Limited", "authorised_date": "1986-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/005/003", "product_name": "Vancocin 500 mg powder for concentrate for solution for infusion and powder for oral solution", "holder": "Flynn Pharma Limited", "authorised_date": "1981-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/005/004", "product_name": "Vancocin 1 g powder for concentrate for solution for infusion and powder for oral solution", "holder": "Flynn Pharma Limited", "authorised_date": "2010-06-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/009/001", "product_name": "Cefuroxime 750 mg Powder for Injection/Infusion", "holder": "Flynn Pharma Limited", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/009/002", "product_name": "Cefuroxime 1.5 g Powder for Injection/Infusion", "holder": "Flynn Pharma Limited", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/013/001", "product_name": "Caspofungin 50mg powder for concentrate for solution for infusion", "holder": "Flynn Pharma Limited", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX", "J02AX04" ], "active_substances": [ "Caspofungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/013/002", "product_name": "Caspofungin 70mg powder for concentrate for solution for infusion", "holder": "Flynn Pharma Limited", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX", "J02AX04" ], "active_substances": [ "Caspofungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/017/001", "product_name": "Fingolimod 0.25 mg hard capsules", "holder": "Flynn Pharma Limited", "authorised_date": "2024-08-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "FINGOLIMOD HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1226/017/002", "product_name": "Fingolimod 0.5 mg hard capsules", "holder": "Flynn Pharma Limited", "authorised_date": "2024-08-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "FINGOLIMOD HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/001/001", "product_name": "Ferrograd 325mg Prolonged release Tablets", "holder": "Teofarma S.R.L.", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "B03AA", "B03AA07" ], "active_substances": [ "Ferrous sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/002/001", "product_name": "Ferrograd C 325mg/500mg Prolonged release Tablets", "holder": "Teofarma S.R.L.", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "B03AA", "B03AA07" ], "active_substances": [ "Ferrous sulfate", "Sodium ascorbate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/003/001", "product_name": "Ferrograd Folic 325mg/0.35mg Prolonged release Tablets", "holder": "Teofarma S.R.L.", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "B03AD", "B03AD03" ], "active_substances": [ "Ferrous sulfate", "Folic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/004/001", "product_name": "Paracodin 10 mg/g Oral Drops, Solution", "holder": "Teofarma S.R.L.", "authorised_date": "1991-10-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "N02AA", "N02AA08" ], "active_substances": [ "Dihydrocodeine hydrorhodanide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/004/002", "product_name": "Paracodin 0.20% w/w Syrup", "holder": "Teofarma S.R.L.", "authorised_date": "1991-10-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N02AA", "N02AA08" ], "active_substances": [ "Dihydrocodeine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/004/003", "product_name": "Paracodin 10 mg Tablets", "holder": "Teofarma S.R.L.", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02AA", "N02AA08" ], "active_substances": [ "Dihydrocodeine Hydrogen Tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/005/001", "product_name": "Prothiaden 25 mg Hard Capsules", "holder": "Teofarma S.R.L.", "authorised_date": "1977-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AA", "N06AA16" ], "active_substances": [ "Dothiepine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1235/005/002", "product_name": "Prothiaden 75mg Coated Tablets", "holder": "Teofarma S.R.L.", "authorised_date": "1977-01-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "N06AA", "N06AA16" ], "active_substances": [ "Dosulepin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1238/001/001", "product_name": "Arlevert 20 mg/40 mg tablets", "holder": "Hennig Arzneimittel GmbH & Co KG", "authorised_date": "2007-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA52" ], "active_substances": [ "Cinnarizine", "Dimenhydrinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/001/001", "product_name": "Formoterol 12 micrograms inhalation powder, hard capsule", "holder": "Laboratorios LICONSA, S.A.", "authorised_date": "2008-03-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03AC", "R03AC13" ], "active_substances": [ "Formoterol fumarate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/017/001", "product_name": "Mirpresoc 20 mg Tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2010-11-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/017/002", "product_name": "Mirpresoc 40 mg Tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2010-11-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/017/003", "product_name": "Mirpresoc 80 mg Tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2010-11-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/025/001", "product_name": "Telmisartan/Hydrochlorothiazide Liconsa 40 mg/12.5 mg tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA07" ], "active_substances": [ "Telmisartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/025/002", "product_name": "Telmisartan/Hydrochlorothiazide Liconsa 80 mg/12.5 mg tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA07" ], "active_substances": [ "Telmisartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/025/003", "product_name": "Telmisartan/Hydrochlorothiazide Liconsa 80 mg/25 mg tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA07" ], "active_substances": [ "Telmisartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/028/001", "product_name": "Atorvastatin Liconsa 10 mg film-coated tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/028/002", "product_name": "Atorvastatin Liconsa 20 mg film-coated tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/028/003", "product_name": "Atorvastatin Liconsa 40 mg film-coated tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/028/004", "product_name": "Atorvastatin Liconsa 80 mg film-coated tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/029/001", "product_name": "Tapentadol Liconsa 25 mg prolonged-release tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/029/002", "product_name": "Tapentadol Liconsa 50 mg prolonged-release tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/029/003", "product_name": "Tapentadol Liconsa 100 mg prolonged-release tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/029/004", "product_name": "Tapentadol Liconsa 150 mg prolonged-release tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/029/005", "product_name": "Tapentadol Liconsa 200 mg prolonged-release tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1239/029/006", "product_name": "Tapentadol Liconsa 250 mg prolonged-release tablets", "holder": "Laboratorios Liconsa S.A.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/006/001", "product_name": "Omnexel®, 400 micrograms prolonged release tablets, film-coated", "holder": "Astellas Pharma Co. Limited", "authorised_date": "2005-03-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/009/001", "product_name": "Vesitirim 5 mg film-coated tablets", "holder": "Astellas Pharma Co. Limited", "authorised_date": "2004-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/009/002", "product_name": "Vesitirim 10 mg film-coated tablets", "holder": "Astellas Pharma Co. Limited", "authorised_date": "2004-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/009/003", "product_name": "Vesitirim 1 mg/ml oral suspension", "holder": "Astellas Pharma Co. Limited", "authorised_date": "2015-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/014/001", "product_name": "Prograf 0.5 mg hard capsules", "holder": "Astellas Pharma Co. Limited", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/014/002", "product_name": "Prograf 1 mg hard capsules", "holder": "Astellas Pharma Co. Limited", "authorised_date": "1996-02-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/014/003", "product_name": "Prograf 5 mg hard capsules", "holder": "Astellas Pharma Co. Limited", "authorised_date": "1996-02-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/014/004", "product_name": "Prograf 5 mg/ml concentrate for solution for infusion", "holder": "Astellas Pharma Co. Limited", "authorised_date": "1996-02-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L04AD", "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1241/016/001", "product_name": "Vesomni 6 mg/0.4 mg modified-release tablets", "holder": "Astellas Pharma Co. Limited", "authorised_date": "2014-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "G04CA53" ], "active_substances": [ "Solifenacin succinate", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1242/001/001", "product_name": "Glucosamine Pharma Nord 400 mg hard capsules", "holder": "Pharma Nord ApS", "authorised_date": "2005-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "GLUCOSAMINE HEMISULPHATE:POTASSIUM CHLORIDE COMPLEX (1:1)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1242/002/001", "product_name": "Melatonin Pharma Nord 3 mg film-coated tablets", "holder": "Pharma Nord ApS", "authorised_date": "2019-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1245/001/001", "product_name": "Lotemax 0.5% w/v eye drops, suspension", "holder": "Dr. Gerhard Mann, chem.-pharm. Fabrik GmbH", "authorised_date": "2006-11-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01BA", "S01BA14" ], "active_substances": [ "Loteprednol etabonate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1253/001/001", "product_name": "Akineton 2 mg tablets", "holder": "Laboratorio Farmaceutico S.I.T.", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04AA", "N04AA02" ], "active_substances": [ "Biperiden hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1253/002/001", "product_name": "Akineton Retard 4 mg prolonged release tablets", "holder": "Laboratorio Farmaceutico S.I.T.", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04AA", "N04AA02" ], "active_substances": [ "Biperiden hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/003/001", "product_name": "Soluprick Positive control, 10 mg/ml, Solution for skin-prick test", "holder": "ALK-Abello A/S", "authorised_date": "2006-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for skin-prick test", "atc_codes": [ "V04CL" ], "active_substances": [ "Histamine dihydrochloride" ], "routes": [ "Intraepidermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/003/002", "product_name": "Soluprick Negative control, Solution for skin prick test", "holder": "ALK-Abello A/S", "authorised_date": "2006-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for skin-prick test", "atc_codes": [ "V04CL" ], "active_substances": [], "routes": [ "Intraepidermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/004/001", "product_name": "GRAZAX 75,000 SQ-T sublingual lyophilisate", "holder": "ALK-Abello A/S", "authorised_date": "2006-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual lyophilisate", "atc_codes": [ "V01AA", "V01AA02" ], "active_substances": [ "Grass pollen allergen extract" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/005/001", "product_name": "Soluprick SQ Timothy Grass (Phleum pratense) pollen 10 HEP Solution for skin-prick testing", "holder": "ALK-Abello A/S", "authorised_date": "2008-06-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for skin-prick test", "atc_codes": [ "V04CL" ], "active_substances": [ "Phleum pratense" ], "routes": [ "Intraepidermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/006/001", "product_name": "Jext 150 micrograms solution for injection in pre-filled pen", "holder": "ALK-Abello A/S", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Adrenaline" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/006/002", "product_name": "Jext 300 micrograms solution for injection in pre-filled pen", "holder": "ALK-Abello A/S", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Adrenaline" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/007/001", "product_name": "ITULAZAX 12 SQ-Bet sublingual lyophilisate", "holder": "ALK-Abello A/S", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "V01AA", "V01AA05" ], "active_substances": [ "Betula verrucosa" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/008/001", "product_name": "ALUTARD SQ Bee 100 000 SQ-U/ml suspension for injection", "holder": "ALK-Abello A/S", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "V01AA07" ], "active_substances": [ "Apis mellifera" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/008/002", "product_name": "ALUTARD SQ Bee Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection", "holder": "ALK-Abello A/S", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "V01AA07" ], "active_substances": [ "Apis mellifera", "Apis mellifera", "Apis mellifera", "Apis mellifera" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/009/001", "product_name": "ALUTARD SQ Wasp 100 000 SQ-U/ml suspension for injection", "holder": "ALK-Abello A/S", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "V01AA07" ], "active_substances": [ "Vespula spp." ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/009/002", "product_name": "ALUTARD SQ Wasp Initial Pack (100 SQ-U/ml, 1 000 SQ-U/ml, 10 000 SQ-U/ml and 100 000 SQ-U/ml) suspension for injection", "holder": "ALK-Abello A/S", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "V01AA07" ], "active_substances": [ "Vespula spp.", "Vespula spp.", "Vespula spp.", "Vespula spp." ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1255/010/001", "product_name": "ACARIZAX 12 SQ-HDM sublingual lyophilisate", "holder": "ALK-Abello A/S", "authorised_date": "2019-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual lyophilisate", "atc_codes": [ "V01AA03" ], "active_substances": [ "Dermatophagoides Farinae Extract", "Dermatophagoides Pteronyssinus Extract" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1270/002/001", "product_name": "Ventizolve 1.26 mg nasal spray, solution in single-dose container", "holder": "Navamedic ASA", "authorised_date": "2019-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution in single-dose container", "atc_codes": [ "V03AB15" ], "active_substances": [ "Naloxone" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1286/055/001", "product_name": "PNEUMOVAX 23 solution for injection in a vial Pneumococcal Polysaccharide Vaccine", "holder": "Merck Sharp & Dohme Ireland (Human Health) Limited", "authorised_date": "2001-05-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J07AL", "J07AL01" ], "active_substances": [ "Pneumococcal vaccine" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1286/055/002", "product_name": "PNEUMOVAX 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine", "holder": "Merck Sharp & Dohme Ireland (Human Health) Limited", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "J07AL", "J07AL01" ], "active_substances": [ "Pneumococcal vaccine" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1286/056/001", "product_name": "VAQTA Paediatric 25 U/0.5 mL, suspension for injection in a prefilled syringe. Hepatitis A vaccine, inactivated, adsorbed. For children and adolescents", "holder": "Merck Sharp & Dohme Ireland (Human Health) Limited", "authorised_date": "1996-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC02" ], "active_substances": [ "Strain cr 326f hepatitis a virus, inactivated 50 u" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1286/056/002", "product_name": "VAQTA Adult 50 U/1 ml, suspension for injection in a prefilled syringe. Hepatitis A vaccine, inactivated, adsorbed. For adults", "holder": "Merck Sharp & Dohme Ireland (Human Health) Limited", "authorised_date": "1996-12-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BC", "J07BC02" ], "active_substances": [ "Strain cr 326f hepatitis a virus, inactivated 50 u" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1286/057/001", "product_name": "VARIVAX powder and solvent for suspension for injection in a pre-filled syringe. Varicella Vaccine (live)", "holder": "Merck Sharp & Dohme Ireland (Human Health) Limited", "authorised_date": "2003-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "J07BK01" ], "active_substances": [ "Varicella virus (oka strain) live attenuated" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1286/058/001", "product_name": "Esmeron 10 mg/ml solution for injection/infusion", "holder": "Merck Sharp & Dohme Ireland (Human Health) Limited", "authorised_date": "1996-08-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/002/001", "product_name": "Divigel 0.1% w/w Gel, 1 mg/dose", "holder": "Orion Corporation", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/003/001", "product_name": "Eldepryl 5 mg Tablets", "holder": "Orion Corporation", "authorised_date": "1996-01-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD01" ], "active_substances": [ "Selegiline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/015/002", "product_name": "Bufomix Easyhaler 160 micrograms/4.5 micrograms/inhalation, inhalation powder", "holder": "Orion Corporation", "authorised_date": "2014-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK", "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/015/003", "product_name": "Bufomix Easyhaler 320 micrograms/9 micrograms/inhalation, inhalation powder", "holder": "Orion Corporation", "authorised_date": "2014-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK", "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/015/004", "product_name": "Bufomix Easyhaler 80 micrograms/4.5 micrograms/inhalation, inhalation powder", "holder": "Orion Corporation", "authorised_date": "2016-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK", "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/019/001", "product_name": "Methotrexate Orion 2.5 mg tablets", "holder": "Orion Corporation", "authorised_date": "2016-10-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01BA", "L01BA01", "L04AX", "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/019/002", "product_name": "Methotrexate Orion 10 mg tablets", "holder": "Orion Corporation", "authorised_date": "2016-10-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01BA", "L01BA01", "L04AX", "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1327/022/001", "product_name": "Migsun 85 mg/500 mg film-coated tablets", "holder": "Orion Corporation", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC" ], "active_substances": [ "Sumatriptan succinate", "Naproxen sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/005/001", "product_name": "Gedarel extra 30/150 micrograms Film Coated Tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2009-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA09" ], "active_substances": [ "Ethinylestradiol", "Desogestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/006/001", "product_name": "Gedarel 20/150 microgram film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2009-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA09" ], "active_substances": [ "Ethinyloestradiol", "Desogestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/007/001", "product_name": "Elvina 0.03mg/3mg film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2010-08-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/008/001", "product_name": "Elvinette 0.02mg/3mg film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/009/001", "product_name": "Alexette 0.02mg/3mg film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/010/001", "product_name": "Azalia 75 microgram film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AC", "G03AC09" ], "active_substances": [ "Desogestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/013/004", "product_name": "Lisopress 20 mg tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/015/001", "product_name": "Ovreena 30 micrograms/150 micrograms coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2006-01-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AA", "G03AA07" ], "active_substances": [ "Ethinylestradiol", "Levonorgestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1330/016/001", "product_name": "Triregol coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2005-02-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AB", "G03AB03" ], "active_substances": [ "Ethinyloestradiol", "Levonorgestrel", "Levonorgestrel", "Ethinylestradiol", "Levonorgestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1330/017/001", "product_name": "Lenzetto 1.53 mg/spray, Transdermal Spray, Solution", "holder": "Gedeon Richter Plc", "authorised_date": "2015-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal spray, solution", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol hemihydrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/018/001", "product_name": "Mistra 2mg/0.03mg Film-Coated Tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA16" ], "active_substances": [ "Dienogest", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/021/001", "product_name": "Ramonna 1500 microgram Tablet", "holder": "Gedeon Richter Plc", "authorised_date": "2006-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AD", "G03AD01" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/022/001", "product_name": "Levosert 52 mg intrauterine delivery system", "holder": "Gedeon Richter Plc", "authorised_date": "2015-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA", "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/022/002", "product_name": "Levosert SHI 52 mg Intrauterine Delivery System", "holder": "Gedeon Richter Plc", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/023/001", "product_name": "Zafrilla 2mg tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03DB08" ], "active_substances": [ "Dienogest" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/027/001", "product_name": "Progesterone 400 mg pessaries", "holder": "Gedeon Richter Plc", "authorised_date": "2017-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G03DA", "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/028/001", "product_name": "Vagirux 10 microgram vaginal tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal tablet", "atc_codes": [ "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/029/001", "product_name": "Cilique 250/35 microgram tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2015-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AA", "G03AA11" ], "active_substances": [ "Norgestimate", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/030/001", "product_name": "Violite 100/20 micrograms film-coated tablets", "holder": "Gedeon Richter Plc", "authorised_date": "2016-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA07" ], "active_substances": [ "Levonorgestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/033/001", "product_name": "Dabigatran etexilate Gedeon Richter 110 mg hard capsules", "holder": "Gedeon Richter Plc", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1330/033/002", "product_name": "Dabigatran etexilate Gedeon Richter 150 mg hard capsules", "holder": "Gedeon Richter Plc", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1335/002/001", "product_name": "Cefixime 200 mg film-coated tablets", "holder": "Orchid Europe Limited", "authorised_date": "2010-10-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01D" ], "active_substances": [ "CEFIXIME TRIHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1336/001/001", "product_name": "Moviprep, powder for oral solution", "holder": "Norgine B.V.", "authorised_date": "2006-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium sulfate anhydrous", "Sodium chloride", "Potassium chloride", "Ascorbic acid", "Sodium ascorbate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1336/001/002", "product_name": "Moviprep Orange, powder for oral solution", "holder": "Norgine B.V.", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium sulfate anhydrous", "Sodium chloride", "Potassium chloride", "Ascorbic acid", "Sodium ascorbate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1336/004/001", "product_name": "Dantrium 25 mg Capsules", "holder": "Norgine B.V.", "authorised_date": "1975-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M03CA", "M03CA01" ], "active_substances": [ "Dantrolene sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1336/004/002", "product_name": "Dantrium 100 mg Capsules", "holder": "Norgine B.V.", "authorised_date": "1975-03-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M03CA", "M03CA01" ], "active_substances": [ "Dantrolene sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1336/005/001", "product_name": "Plenvu powder for oral solution", "holder": "Norgine B.V.", "authorised_date": "2017-12-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium 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{ "licence_number": "PA1336/010/001", "product_name": "Angusta 25 microgram tablets", "holder": "Norgine B.V.", "authorised_date": "2020-10-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02AD06" ], "active_substances": [ "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/004/001", "product_name": "Valsartan/hydrochlorothiazide Krka 80 mg/12.5 mg Film-coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Hydrochlorothiazide", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/004/002", "product_name": "Valsartan/hydrochlorothiazide Krka 160 mg/12.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/004/003", "product_name": "Valsartan/hydrochlorothiazide Krka 160 mg/25 mg film-coated 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"Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/004/005", "product_name": "Valsartan/hydrochlorothiazide Krka 320 mg/25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/006/001", "product_name": "Nolpaza 20 mg gastro-resistant tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/006/002", "product_name": "Nolpaza 40 mg gastro-resistant tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2009-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/009/004", "product_name": "Atorvastatin Krka 80 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/010/006", "product_name": "Valsartan Krka 40 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], 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"KRKA, d.d., Novo mesto", "authorised_date": "2012-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/010/009", "product_name": "Valsartan Krka 320 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-06-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply 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"registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/011/003", "product_name": "Candesartan Hydrochlorothiazide Krka 32mg/12.5mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/011/004", "product_name": "Candesartan Hydrochlorothiazide Krka 32mg/25mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/012/001", "product_name": "Rolpryna SR 2 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/012/002", "product_name": "Rolpryna SR 4 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/012/003", "product_name": "Rolpryna SR 8 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/014/003", "product_name": "Donepezil Krka 5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/014/004", "product_name": "Donepezil Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/015/001", "product_name": "Galsya SR 8 mg prolonged-release capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/015/002", "product_name": "Galsya SR 16 mg prolonged-release capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/015/003", "product_name": "Galsya SR 24 mg prolonged-release capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/016/001", "product_name": "Rosuvastatin Krka 5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/016/002", "product_name": "Rosuvastatin Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/016/003", "product_name": "Rosuvastatin Krka 20 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/016/004", "product_name": "Rosuvastatin Krka 40 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/017/001", "product_name": "Esomeprazole Krka 20 mg hard gastro-resistant capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/017/002", "product_name": "Esomeprazole Krka 40 mg hard gastro-resistant capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/019/001", "product_name": "Sertraline Krka 50 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/019/002", "product_name": "Sertraline Krka 100 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/020/001", "product_name": "Losartan Krka 25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-01-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/020/002", "product_name": "Losartan Krka 50 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/020/003", "product_name": "Losartan Krka 100 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/022/001", "product_name": "Icorvida SR 1.5mg Prolonged-release Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C03BA", "C03BA11" ], "active_substances": [ "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/023/001", "product_name": "Atorvastatin Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/023/002", "product_name": "Atorvastatin Krka 20 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/023/003", "product_name": "Atorvastatin Krka 40 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/026/003", "product_name": "Candesartan Krka 16 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2012-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) 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[ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/027/002", "product_name": "Quetiapine Krka 100mg Film-coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-06-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/027/003", "product_name": "Quetiapine Krka 200mg Film-coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-06-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/027/004", "product_name": "Quetiapine Krka 300mg Film-coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-06-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/028/001", "product_name": "Simvastatin Krka 10 mg Film-Coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2003-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/028/002", "product_name": "Simvastatin Krka 20 mg Film Coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2003-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/028/003", "product_name": "Simvastatin Krka 40 mg Film Coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2003-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/029/001", "product_name": "Enalapril/Lercanidipine Krka 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"dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/030/001", "product_name": "Rabeprazole Krka 10mg Gastro-Resistant Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-08-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC04" ], "active_substances": [ "Rabeprazole sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/030/002", "product_name": "Rabeprazole Krka 20mg Gastro-Resistant Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-08-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC04" ], "active_substances": [ "Rabeprazole sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/031/001", "product_name": "Bisoprolol Krka 2.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/032/001", "product_name": "Nolpacid 20 mg gastro-resistant tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-11-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/033/001", "product_name": "Celecoxib Krka 100 mg capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AH", "M01AH01" ], "active_substances": [ "Celecoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/033/002", "product_name": "Celecoxib Krka 200 mg capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AH", "M01AH01" ], "active_substances": [ "Celecoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/034/001", "product_name": "Amlodipine Krka 5 mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/034/002", "product_name": "Amlodipine Krka 10 mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/035/001", "product_name": "Ciprofloxacin Krka 250 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2005-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/035/002", "product_name": "Ciprofloxacin Krka 500 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2005-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/035/003", "product_name": "Ciprofloxacin Krka 750 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2005-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/036/001", "product_name": "Venlafex XL 37.5 mg prolonged-release capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/036/002", "product_name": "Venlafex XL 75 mg prolonged-release capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/036/003", "product_name": "Venlafex XL 150 mg prolonged-release capsules, hard", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"active_substances": [ "Carvedilol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/037/003", "product_name": "Carvedilol Krka 12.5 mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AG", "C07AG02" ], "active_substances": [ "Carvedilol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/037/004", "product_name": "Carvedilol Krka 25 mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AG", "C07AG02" ], "active_substances": [ "Carvedilol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/038/001", "product_name": "Kamiren 4 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2006-03-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/039/001", "product_name": "Montelukast 4 mg chewable tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-10-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/039/002", "product_name": "Montelukast 5 mg chewable tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-10-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ 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"Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/040/003", "product_name": "Losartan/Hydrochlorothiazide Krka 100 mg/25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2013-11-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrocholothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/041/001", "product_name": "Perindopril Krka 2 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tert-butylamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/041/002", "product_name": "Perindopril Krka 4 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA04" ], "active_substances": [ "Perindopril tert-butylamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/042/004", "product_name": "Ramipril Krka 10 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA05" ], "active_substances": [ "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/043/001", "product_name": "Levocetirizine Krka 5mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2011-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/044/001", "product_name": "Amoxicillin/clavulanic acid Krka 500 mg/125 mg Film-Coated Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-09-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", 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"registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/046/001", "product_name": "Escitalopram Krka 5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) 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"holder": "KRKA, d.d., Novo mesto", "authorised_date": "2014-05-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA10" ], "active_substances": [ "Azithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/048/001", "product_name": "Levofloxacin Krka 250 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA12" ], "active_substances": [ "Levofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/050/006", "product_name": "Pregabalin Krka 200 mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/050/007", "product_name": "Pregabalin Krka 225 mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/050/008", "product_name": "Pregabalin Krka 300 mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/051/001", "product_name": "Loxentia 20mg hard gastro-resistant capsule", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-05-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX", "N06AX21" ], "active_substances": [ "Duloxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/051/002", "product_name": "Duloxetine Krka 30 mg hard gastro-resistant capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/051/003", "product_name": "Loxentia 40mg hard gastro-resistant capsule", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-05-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX", "N06AX21" ], "active_substances": [ "Duloxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/051/004", "product_name": "Duloxetine Krka 60 mg hard gastro-resistant capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/052/001", "product_name": "Tramadol/Paracetamol Krka 37.5mg/325mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ13" ], "active_substances": [ "Paracetamol", "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/054/001", "product_name": "Imatinib Krka d.d 100 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-01-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE01" ], "active_substances": [ "Imatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/054/002", "product_name": "Imatinib Krka d.d. 400 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-01-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE01" ], "active_substances": [ "Imatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/055/001", "product_name": "Amlodipine/Valsartan Krka 5 mg/ 80 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BX", "C10BX09" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/055/002", "product_name": "Amlodipine/Valsartan Krka 5 mg/ 160 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB01" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/055/003", "product_name": "Amlodipine/Valsartan Krka 10 mg/160 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB01" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/055/004", "product_name": "Amlodipine/Valsartan Krka 5 mg/320 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB01" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/055/005", "product_name": "Amlodipine/Valsartan Krka 10 mg/320 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB01" ], "active_substances": [ "Amlodipine", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/057/001", "product_name": "Linezolid Krka 600 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-09-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/057/002", "product_name": "Linezolid 2 mg/ml solution for infusion", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/058/001", "product_name": "Septanazal for children 0.5 mg/ 50 mg in 1 ml nasal spray solution", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AB", "R01AB06" ], "active_substances": [ "Xylometazoline hydrochloride", "Dexpanthenol" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/058/002", "product_name": "Septanazal 1 mg/ 50 mg in 1 ml nasal spray solution", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AB", "R01AB06" ], "active_substances": [ "Xylometazoline hydrochloride", "Dexpanthenol" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/060/001", "product_name": "Olmesartan Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/060/002", "product_name": "Olmesartan Krka 20 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/060/003", "product_name": "Olmesartan Krka 40 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/061/001", "product_name": "Olmesartan/Hydrochlorothiazide Krka 20 mg/12.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/061/002", "product_name": "Olmesartan/Hydrochlorothiazide Krka 20 mg/25 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"Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/061/004", "product_name": "Olmesartan/Hydrochlorothiazide Krka 40 mg/25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA08" ], "active_substances": [ "Olmesartan medoxomil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/062/001", "product_name": "Lansoprazole Krka 15 mg Gastro-resistant 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prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/063/001", "product_name": "Septabene eucalyptus 3 mg/1 mg lozenges", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-04-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA20" ], "active_substances": [ "BENZYDAMINE HYDROCHLORIDE", "Cetylpyridinium chloride" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/063/002", "product_name": "Septabene Lemon and Honey 3 mg/1 mg lozenges", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2019-03-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA20" ], "active_substances": [ "BENZYDAMINE HYDROCHLORIDE", "Cetylpyridinium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/063/003", "product_name": "Septabene lemon and elderflower 3 mg /1 mg lozenges", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2019-03-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA20" ], "active_substances": [ "BENZYDAMINE HYDROCHLORIDE", "Cetylpyridinium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/064/001", "product_name": "Etoricoxib Krka 30 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/064/002", "product_name": "Etoricoxib Krka 60 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/064/003", "product_name": "Etoricoxib Krka 90 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/064/004", "product_name": "Etoricoxib Krka 120 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/065/001", "product_name": "Ivabradine Krka 5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/065/002", "product_name": "Ivabradine Krka 7.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C01EB", "C01EB17" ], "active_substances": [ "Ivabradine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/066/001", "product_name": "Ezetimibe Krka 10 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AX", "C10AX09" ], "active_substances": [ "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/067/001", "product_name": "Ezetimibe/Simvastatin Krka 10 mg/10 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-03-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/067/002", "product_name": "Ezetimibe/Simvastatin Krka 10 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(B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/068/001", "product_name": "Clarithromycin Krka 250 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/068/002", "product_name": "Clarithromycin Krka 500 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/069/001", "product_name": "Dutasteride Krka 0.5 mg capsules, soft", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G04CB", "G04CB02" ], "active_substances": [ "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/070/001", "product_name": "Aspirin Krka 75 mg gastro-resistant tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "B01AC", "B01AC06" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/071/001", "product_name": "Tadalafil Krka 2.5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-06-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/071/002", "product_name": "Tadalafil Krka 5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-06-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/071/003", "product_name": "Tadalafil Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-06-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/071/004", "product_name": "Tadalafil Krka 20 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-06-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/073/001", "product_name": "Vardenafil Krka 5mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-04-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE09" ], "active_substances": [ "VARDENAFIL HYDROCHLORIDE TRIHYDRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/073/002", "product_name": "Vardenafil Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-04-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated 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"licence_number": "PA1347/075/001", "product_name": "Olmesartan/Amlodipine Krka 20 mg/5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/075/002", "product_name": "Olmesartan/Amlodipine Krka 40 mg/5 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/075/003", "product_name": "Olmesartan/Amlodipine Krka 40 mg/10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/076/001", "product_name": "Vildagliptin Krka 50 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A10BH", "A10BH02" ], "active_substances": [ "Vildagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/078/001", "product_name": "Eplerenone Krka 25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/078/002", "product_name": "Eplerenone Krka 50 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/079/001", "product_name": "Tramadol Krka 50mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-03-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/080/001", "product_name": "Prasugrel Krka 5 mg Film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-08-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC22" ], "active_substances": [ "Prasugrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/080/002", "product_name": "Prasugrel Krka 10 mg Film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2018-08-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC22" ], "active_substances": [ "Prasugrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/084/001", "product_name": "Perindopril/amlodipine Krka 4 mg/5 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB", "C09BB04" ], "active_substances": [ "Perindopril tert-butylamine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/084/002", "product_name": "Perindopril/amlodipine Krka 4 mg/10 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB", "C09BB04" ], "active_substances": [ "Perindopril tert-butylamine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/084/003", "product_name": "Perindopril/amlodipine Krka 8 mg/5 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB", "C09BB04" ], "active_substances": [ "Perindopril tert-butylamine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/084/004", "product_name": "Perindopril/amlodipine Krka 8 mg/10 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB", "C09BB04" ], "active_substances": [ "Perindopril tert-butylamine", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/085/001", "product_name": "Nolxado 10 mg/5 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/085/002", "product_name": "Nolxado 20 mg/10 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/085/003", "product_name": "Nolxado 40 mg/20 mg prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/086/001", "product_name": "TANYZ 400 micrograms hard modified-release capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2019-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/087/001", "product_name": "Tamzeltos 400 micrograms prolonged-release tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2019-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/088/001", "product_name": "Rasagiline Krka 1 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-10-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Rasagiline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/089/001", "product_name": "Aripiprazole Krka 5mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-02-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/089/002", "product_name": "Aripiprazole Krka 10mg Tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2015-02-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ 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"PA1347/099/003", "product_name": "Lacosamide Krka 150 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2020-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/099/004", "product_name": "Lacosamide Krka 200 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2020-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/110/001", "product_name": "Dabigatran Etexilate Krka 75 mg hard capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-01-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "B01AE07" ], "active_substances": [ "Dabigatran etexilate mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"product_name": "Dapagliflozin Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2023-12-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin propanediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/112/001", "product_name": "Perindopril arginine/Indapamide/Amlodipine Krka 5 mg/1.25 mg/5 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", 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"product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/114/001", "product_name": "Apremilast Krka 10 mg film-coated tablets Apremilast Krka 20 mg film-coated tablets Apremilast Krka 30 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/114/002", "product_name": "Apremilast Krka 30 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/115/001", "product_name": "Edoxaban Krka 15 mg film-coated tablet", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-11-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/115/002", "product_name": "Edoxaban Krka 30 mg film-coated tablet", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-11-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/115/003", "product_name": "Edoxaban Krka 60 mg film-coated tablet", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-11-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/116/001", "product_name": "Ezetimibe/Atorvastatin Krka 10 mg/10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin 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"dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/117/001", "product_name": "Dalnecombi 7 mg/5 mg/2.5 mg tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Amlodipine besilate", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/118/001", "product_name": "Dapagliflozin/Metformin Krka 5 mg/850 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD15" ], "active_substances": [ "Dapagliflozin propanediol monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/118/002", "product_name": "Dapagliflozin/Metformin Krka 5 mg/1000 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD15" ], "active_substances": [ "Dapagliflozin propanediol monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/119/001", "product_name": "Sacubitril/Valsartan Krka 24 mg/26 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/119/002", "product_name": "Sacubitril/Valsartan Krka 49 mg/51 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/119/003", "product_name": "Sacubitril/Valsartan Krka 97 mg/103 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/121/002", "product_name": "Vortioxetine Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/121/003", "product_name": "Vortioxetine Krka 15 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/121/004", "product_name": "Vortioxetine Krka 20 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX26" ], "active_substances": [ "Vortioxetine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/122/001", "product_name": "Empagliflozin/Metformin Krka 5 mg/850 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2026-05-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD20" ], "active_substances": [ "Empagliflozin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/122/002", "product_name": "Empagliflozin/Metformin Krka 5 mg/1000 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2026-05-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD20" ], "active_substances": [ "Empagliflozin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/122/003", "product_name": "Empagliflozin/Metformin Krka 12.5 mg/850 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2026-05-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD20" ], "active_substances": [ "Empagliflozin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/122/004", "product_name": "Empagliflozin/Metformin Krka 12.5 mg/1000 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2026-05-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD20" ], "active_substances": [ "Empagliflozin", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/123/001", "product_name": "ESCADRA 20 mg hard gastro-resistant capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/123/002", "product_name": "ESCADRA 40 mg hard gastro-resistant capsules", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2010-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/124/001", "product_name": "Empagliflozin Krka 10 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK03" ], "active_substances": [ "Empagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1347/124/002", "product_name": "Empagliflozin Krka 25 mg film-coated tablets", "holder": "KRKA, d.d., Novo mesto", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK03" ], "active_substances": [ "Empagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1350/006/001", "product_name": "Calrecia 100 mmol/l, solution for infusion", "holder": "Fresenius Medical Care Deutschland GmbH", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA07" ], "active_substances": [ "Calcium chloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1350/008/001", "product_name": "Cifoban 136 mmol/l solution for infusion", "holder": "Fresenius Medical Care Deutschland GmbH", "authorised_date": "2022-01-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B05ZB" ], "active_substances": [ "Trisodium citrate dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1350/009/001", "product_name": "multiBic potassium-free solution for haemodialysis/haemofiltration", "holder": "Fresenius Medical Care Deutschland GmbH", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Glucose monohydrate", "Sodium hydrogen carbonate" ], "routes": [ "Haemodialysis", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1350/009/002", "product_name": "multiBic 2 mmol/l potassium solution for haemodialysis/haemofiltration", "holder": "Fresenius Medical Care Deutschland GmbH", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Glucose monohydrate", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Haemodialysis", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1350/009/003", "product_name": "multiBic 4 mmol/l potassium solution for haemodialysis/haemofiltration", "holder": "Fresenius Medical Care Deutschland GmbH", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Glucose monohydrate", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Haemodialysis", "Intravascular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1353/005/001", "product_name": "Embesin 20 IU/ml concentrate for solution for infusion", "holder": "Orpha-Devel Handels und Vertriebs GmbH", "authorised_date": "2018-03-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "H01BA", "H01BA01" ], "active_substances": [ "Argipressin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1353/006/001", "product_name": "Treposuvi 1 mg/ml solution for infusion", "holder": "Orpha-Devel Handels und Vertriebs GmbH", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1353/006/002", "product_name": "Treposuvi 2.5 mg/ml solution for infusion", "holder": "Orpha-Devel Handels und Vertriebs GmbH", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1353/006/003", "product_name": "Treposuvi 5 mg/ml solution for infusion", "holder": "Orpha-Devel Handels und Vertriebs GmbH", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1353/006/004", "product_name": "Treposuvi 10 mg/ml solution for infusion", "holder": "Orpha-Devel Handels und Vertriebs GmbH", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1353/007/001", "product_name": "Rapibloc 300 mg powder for solution for infusion", "holder": "Orpha-Devel Handels und Vertriebs GmbH", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "C07AB" ], "active_substances": [ "Landiolol hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1368/002/001", "product_name": "Ireven 75 mg prolonged-release capsules, hard", "holder": "Pharmathen S.A.", "authorised_date": "2008-07-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1368/002/002", "product_name": "Ireven 150mg prolonged-release capsules, hard", "holder": "Pharmathen S.A.", "authorised_date": "2008-07-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1391/003/001", "product_name": "Itoco 20 mg/ml eye drops, solution", "holder": "Farmaprojects S.A.U", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EC03" ], "active_substances": [ "Dorzolamide hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1391/004/001", "product_name": "Tidimaz 20 mg/ml + 5 mg/ml eye drops, solution", "holder": "Farmaprojects S.A.U", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED51" ], "active_substances": [ "Dorzolamide hydrochloride", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1391/005/001", "product_name": "Bitifrin 0.3 mg/ml + 5 mg/ml eye drops, solution", "holder": "Farmaprojects S.A.U", "authorised_date": "2022-09-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED51" ], "active_substances": [ "Bimatoprost", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1391/006/001", "product_name": "Iricryn 0.3 mg/ml eye drops, solution", "holder": "Farmaprojects S.A.U", "authorised_date": "2022-09-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EE03" ], "active_substances": [ "Bimatoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1391/007/001", "product_name": "Loravis 50 microgram/ml eye drops, solution", "holder": "Farmaprojects S.A.U", "authorised_date": "2022-01-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1391/009/001", "product_name": "Loracom 50 microgram/ml + 5 mg/ml eye drops, solution", "holder": "Farmaprojects S.A.U", "authorised_date": "2025-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED51" ], "active_substances": [ "Latanoprost", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/001/001", "product_name": "Urispas 200 mg Film-coated Tablets", "holder": "Recordati Ireland Limited", "authorised_date": "1990-10-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD02" ], "active_substances": [ "Flavoxate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/002/001", "product_name": "Lercaril 10 mg/10 mg film-coated tablets", "holder": "Recordati Ireland Limited", "authorised_date": "2008-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Lercanidipine hydrochloride", "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/002/002", "product_name": "Lercaril 20 mg/10 mg film-coated tablets", "holder": "Recordati Ireland Limited", "authorised_date": "2008-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Enalapril maleate", "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/002/003", "product_name": "Lercaril 20 mg/20 mg film-coated tablets", "holder": "Recordati Ireland Limited", "authorised_date": "2014-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Enalapril maleate", "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/003/001", "product_name": "Vitaros 2 mg/g cream", "holder": "Recordati Ireland Limited", "authorised_date": "2015-10-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "G04BE", "G04BE01" ], "active_substances": [ "Alprostadil" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/003/002", "product_name": "Vitaros 3 mg/g cream", "holder": "Recordati Ireland Limited", "authorised_date": "2015-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "G04BE", "G04BE01" ], "active_substances": [ "Alprostadil" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1404/007/001", "product_name": "Betaloc 1 mg/ml solution for injection", "holder": "Recordati Ireland Limited", "authorised_date": "1983-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C07AB", "C07AB02" ], "active_substances": [ "METOPROLOL TARTRATE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1405/001/001", "product_name": "Gamunex 10%, 100 mg/ml, solution for infusion", "holder": "Grifols Deutschland GmbH", "authorised_date": "2006-08-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Immunoglobulin human normal" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1405/002/001", "product_name": "Prolastin1000mg, powder and solvent for solution for infusion", "holder": "Grifols Deutschland GmbH", "authorised_date": "2007-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02AB", "B02AB02" ], "active_substances": [ "Alpha-1-proteinase inhibitor" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1405/002/002", "product_name": "Prolastin 4000 mg, powder and solvent for solution for infusion", "holder": "Grifols Deutschland GmbH", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02AB02" ], "active_substances": [ "Human alpha1-proteinase inhibitor" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1405/002/003", "product_name": "Prolastin 5000 mg, powder and solvent for solution for infusion", "holder": "Grifols Deutschland GmbH", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02AB02" ], "active_substances": [ "Human alpha1-proteinase inhibitor" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/003/001", "product_name": "Dianette 2 mg/35 microgram coated tablets", "holder": "Bayer Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03HB", "G03HB01" ], "active_substances": [ "Cyproterone acetate", "Ethinylestradiol ph.eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/004/001", "product_name": "Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution", "holder": "Bayer Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral/rectal solution", "atc_codes": [ "V08AA01" ], "active_substances": [ "Sodium amidotrizoate", "Amidotrizoate meglumine" ], "routes": [ "Oral use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/005/001", "product_name": "Logynon Tablets", "holder": "Bayer Limited", "authorised_date": "1981-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AB", "G03AB03" ], "active_substances": [ "Levonorgestrel", "Levonorgestrel", "Levonorgestrel", "Ethinylestradiol", "Ethinylestradiol", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/008/001", "product_name": "Mirena 52 mg intrauterine delivery system", "holder": "Bayer Limited", "authorised_date": "1998-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA", "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/012/001", "product_name": "Urografin 30 % w/v Solution for infusion", "holder": "Bayer Limited", "authorised_date": "1988-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "V08AA01" ], "active_substances": [ "Sodium amidotrizoate", "Meglumine amidotrizoate", "Sodium hydroxide" ], "routes": [], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/013/001", "product_name": "Angeliq 1 mg/2 mg film-coated tablets", "holder": "Bayer Limited", "authorised_date": "2004-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA17" ], "active_substances": [ "Estradiol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/018/001", "product_name": "Gadovist 1.0 mmol/ml solution for injection", "holder": "Bayer Limited", "authorised_date": "2000-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA09" ], "active_substances": [ "Gadobutrol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/018/002", "product_name": "Gadovist 1.0 mmol/ml solution for injection in prefilled syringe", "holder": "Bayer Limited", "authorised_date": "2001-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V08CA", "V08CA09" ], "active_substances": [ "Gadobutrol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/018/003", "product_name": "Gadovist 1.0 mmol/ml solution for injection", "holder": "Bayer Limited", "authorised_date": "2000-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA09" ], "active_substances": [ "Gadobutrol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/018/004", "product_name": "Gadovist 1.0 mmol/ml solution for injection in prefilled cartridge", "holder": "Bayer Limited", "authorised_date": "2009-04-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "V08CA", "V08CA09" ], "active_substances": [ "Gadobutrol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/021/001", "product_name": "Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe", "holder": "Bayer Limited", "authorised_date": "2004-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V08CA", "V08CA10" ], "active_substances": [ "Gadoxetic acid, disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/021/002", "product_name": "Primovist 0.25 mmol/ml, solution for injection", "holder": "Bayer Limited", "authorised_date": "2004-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA10" ], "active_substances": [ "Gadoxetic acid, disodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/023/001", "product_name": "Yasmin 0.03 mg/3 mg film-coated tablets", "holder": "Bayer Limited", "authorised_date": "2000-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/024/001", "product_name": "Yasminelle 0.02 mg/3 mg film-coated tablets", "holder": "Bayer Limited", "authorised_date": "2006-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Ethinylestradiol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/032/001", "product_name": "Alka-Seltzer Effervescent Tablets Acetylsalicylic Acid (Aspirin) 324mg Sodium Hydrogen Carbonate 1744mg Citric Acid 965mg", "holder": "Bayer Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BA", "N02BA01" ], "active_substances": [ "Aspirin", "Sodium hydrogen carbonate", "Citric acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/037/001", "product_name": "Aspirin 300mg Effervescent tablets", "holder": "Bayer Limited", "authorised_date": "1976-06-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BA", "N02BA01" ], "active_substances": [ "Aspirin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1410/039/001", "product_name": "Canesten Combi Pessary & Cream", "holder": "Bayer Limited", "authorised_date": "2001-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream + pessary", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole", "Clotrimazole" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/002", "product_name": "Canesten Cream", "holder": "Bayer Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC01" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/003", "product_name": "Canesten Cream Combi Internal & External Creams", "holder": "Bayer Limited", "authorised_date": "2006-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole", "Clotrimazole" ], "routes": [ "Cutaneous use", "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/005", "product_name": "Canesten Duopak", "holder": "Bayer Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream + pessary", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole", "Clotrimazole" ], "routes": [ "Topical use", "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/006", "product_name": "Canesten Internal Cream", "holder": "Bayer Limited", "authorised_date": "1986-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/007", "product_name": "Canesten 100 mg Pessary", "holder": "Bayer Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/008", "product_name": "Canesten 200 mg Pessary", "holder": "Bayer Limited", "authorised_date": "1979-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/009", "product_name": "Canesten 500 mg Pessary", "holder": "Bayer Limited", "authorised_date": "1983-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/010", "product_name": "Canesten 500 mg Soft Vaginal Capsule", "holder": "Bayer Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal capsule, soft", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/012", "product_name": "Canesten Thrush Cream", "holder": "Bayer Limited", "authorised_date": "1981-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/013", "product_name": "Canesten Athlete’s Foot Cream", "holder": "Bayer Limited", "authorised_date": "2015-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC01" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/039/014", "product_name": "Canesten Combi Soft Vaginal Capsule & Cream 500 mg Soft Vaginal Capsule and 2 % w/w Cream", "holder": "Bayer Limited", "authorised_date": "2016-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream + vaginal capsule, soft", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole", "Clotrimazole" ], "routes": [ "Cutaneous use", "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/040/001", "product_name": "Canesten HC CreamClotrimazole 1.0% w/w Hydrocortisone 1.0% w/w", "holder": "Bayer Limited", "authorised_date": "1984-08-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC20" ], "active_substances": [ "Clotrimazole", "Hydrocortisone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/040/002", "product_name": "Canesten HC 1% w/w + 1% w/w Cream", "holder": "Bayer Limited", "authorised_date": "2018-06-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC20" ], "active_substances": [ "Clotrimazole", "HYDROCORTISONE ACETATE" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/041/001", "product_name": "CanOral 150 mg capsule", "holder": "Bayer Limited", "authorised_date": "2005-04-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/042/001", "product_name": "Cystopurin 3g Granules for oral solution", "holder": "Bayer Limited", "authorised_date": "1995-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "A12BA", "A12BA02" ], "active_substances": [ "Potassium citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/047/001", "product_name": "Bepantiseptic First Aid Cream", "holder": "Bayer Limited", "authorised_date": "1987-01-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D08AC", "D08AC52" ], "active_substances": [ "Phenol", "Chlorhexidine digluconate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/050/001", "product_name": "Redoxon Double Action 1000 mg/10 mg Effervescent Tablets", "holder": "Bayer Limited", "authorised_date": "2001-11-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "A11GB" ], "active_substances": [ "Ascorbic acid", "Zinc citrate trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/051/001", "product_name": "Rennie Deflatine Chewable Tablets Calcium Carbonate 680mg Magnesium Carbonate 80mg Simeticone 25mg", "holder": "Bayer Limited", "authorised_date": "1994-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AA01", "A02AC01", "A02AX", "A03AX13" ], "active_substances": [ "Calcium carbonate", "Magnesium carbonate", "Simeticone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/052/003", "product_name": "Rennie Dual Action Chewable Tablets Calcium carbonate 625mg Magnesium carbonate 73.5mg Alginic acid 150mg", "holder": "Bayer Limited", "authorised_date": "2009-02-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AD" ], "active_substances": [ "Alginic acid", "Calcium carbonate", "Magnesium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/053/001", "product_name": "Rennie Peppermint 680mg/80mg Chewable Tablets", "holder": "Bayer Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AA01", "A02AC01", "A02AX" ], "active_substances": [ "Calcium carbonate", "Magnesium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/053/002", "product_name": "Rennie Spearmint 680mg/80mg Chewable tablets", "holder": "Bayer Limited", "authorised_date": "1991-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AA01", "A02AC01", "A02AX" ], "active_substances": [ "Calcium carbonate", "Magnesium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/053/003", "product_name": "Rennie Sugar Free 680 mg/80 mg Chewable tablets", "holder": "Bayer Limited", "authorised_date": "1991-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AD", "A02AD01" ], "active_substances": [ "Magnesium carbonate", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/054/001", "product_name": "Rennie Orange 500mg Chewable Tablets", "holder": "Bayer Limited", "authorised_date": "1990-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AC01" ], "active_substances": [ "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/056/001", "product_name": "Yaz 0.02 mg/3 mg film-coated tablets", "holder": "Bayer Limited", "authorised_date": "2008-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Ethinylestradiol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/058/001", "product_name": "Qlaira film-coated tablets", "holder": "Bayer Limited", "authorised_date": "2009-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA16" ], "active_substances": [ "Estradiol valerate", "Estradiol valerate", "Dienogest", "Dienogest", "Estradiol valerate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/066/001", "product_name": "Losec Control 20 mg gastro-resistant tablets", "holder": "Bayer Limited", "authorised_date": "2011-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/068/001", "product_name": "Jaydess 13.5 mg intrauterine delivery system", "holder": "Bayer Limited", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA", "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/075/001", "product_name": "Clarityn 10 mg Tablets", "holder": "Bayer Limited", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/075/002", "product_name": "Clarityn 1mg/1ml Syrup", "holder": "Bayer Limited", "authorised_date": "1994-01-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R06AX", "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/081/001", "product_name": "Kyleena 19.5 mg intrauterine delivery system", "holder": "Bayer Limited", "authorised_date": "2016-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA", "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/082/001", "product_name": "Dotagraf 279.32 mg/ml solution for injection", "holder": "Bayer Limited", "authorised_date": "2016-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA02" ], "active_substances": [ "DOTA ACID", "Meglumine", "Gadoteric acid", "Gadolinium oxide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/082/002", "product_name": "Dotagraf 279.32 mg/ml solution for injection", "holder": "Bayer Limited", "authorised_date": "2016-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA02" ], "active_substances": [ "Gadolinium oxide", "DOTA ACID", "Meglumine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/083/001", "product_name": "Canespor 10 mg/g cream", "holder": "Bayer Limited", "authorised_date": "2018-03-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC10" ], "active_substances": [ "Bifonazole" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/089/001", "product_name": "Rennie 750 mg Medicated Chewing Gum", "holder": "Bayer Limited", "authorised_date": "2022-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "A02AC01" ], "active_substances": [ "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1410/090/001", "product_name": "Microlite 100 microgram/20 microgram coated tablets", "holder": "Bayer Limited", "authorised_date": "2024-09-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AA07" ], "active_substances": [ "Levonorgestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1411/002/001", "product_name": "Temozolomide FAIR-MED 5 mg hard capsules", "holder": "Eirgen Pharma Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1411/002/002", "product_name": "Temozolomide FAIR-MED 20 mg hard capsules", "holder": "Eirgen Pharma Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1411/002/003", "product_name": "Temozolomide FAIR-MED 100 mg hard capsules", "holder": "Eirgen Pharma Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1411/002/004", "product_name": "Temozolomide FAIR-MED 140 mg hard capsules", "holder": "Eirgen Pharma Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1411/002/005", "product_name": "Temozolomide FAIR-MED 180 mg hard capsules", "holder": "Eirgen Pharma Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1411/002/006", "product_name": "Temozolomide FAIR-MED 250 mg hard capsules", "holder": "Eirgen Pharma Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01AX", "L01AX03" ], "active_substances": [ "Temozolomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/003/001", "product_name": "Amlotan 5 mg tablet", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2006-08-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/003/002", "product_name": "Amlotan 10 mg tablet", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2006-08-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/004/001", "product_name": "Itraconazole 10mg/ml oral solution", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2013-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "J02AC", "J02AC02" ], "active_substances": [ "Itraconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/005/001", "product_name": "Trimethoprim 10 mg/ml Oral Suspension", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J01EA01" ], "active_substances": [ "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/006/001", "product_name": "Anagrelide 0.5 mg Hard Capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2018-04-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XX", "L01XX35" ], "active_substances": [ "Anagrelide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/007/001", "product_name": "Carbomix 50 g Granules for Oral Suspension", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1992-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "A07BA", "A07BA01" ], "active_substances": [ "Charcoal, activated" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Competence of personnel (Article 23 of Directive No 2010/63/EU)" }, { "licence_number": "PA1418/008/001", "product_name": "Trimoptin Tablets 100 mg", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EA", "J01EA01" ], "active_substances": [ "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/008/002", "product_name": "Trimoptin Tablets 200 mg", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EA", "J01EA01" ], "active_substances": [ "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/009/001", "product_name": "Tramadol Hydrochloride/Paracetamol 37.5 mg/325 mg Film-Coated Tablets", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2016-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX", "N02AX52" ], "active_substances": [ "Tramadol hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/010/001", "product_name": "Doxycycline 50 mg hard capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA02" ], "active_substances": [ "Doxycycline hyclate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/010/002", "product_name": "Doxycycline 100 mg hard capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA02" ], "active_substances": [ "Doxycycline hyclate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/011/001", "product_name": "Phenylephrine Hydrochloride 10 mg/ml solution for injection/infusion", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C01CA06" ], "active_substances": [ "Phenylephrine hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/012/001", "product_name": "Amikacin 250 mg/ ml Solution for injection/infusion", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2024-09-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB06" ], "active_substances": [ "AMIKACIN SULFATE" ], "routes": [ "Intramuscular use", "Intrapericardial use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/013/001", "product_name": "Oramox 125 mg/5 ml powder for oral suspension", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1988-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/013/002", "product_name": "Oramox 250 mg/5 ml powder for oral suspension", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1988-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/013/003", "product_name": "Oramox 250 mg hard capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1988-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/013/004", "product_name": "Oramox 500 mg hard capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1988-09-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/014/001", "product_name": "Kopen Sugar Free 125 mg/5 ml Powder for Oral Solution", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1988-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "Phenoxymethylpenicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1418/014/002", "product_name": "Kopen Sugar Free 250 mg/5 ml Powder for Oral Solution", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1988-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "Phenoxymethylpenicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1418/014/003", "product_name": "Kopen 250mg Tablets", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1987-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "Phenoxymethylpenicillin potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/015/001", "product_name": "Flucloxacillin 125mg/5ml Oral Solution BP", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2011-10-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/016/001", "product_name": "Flucloxacillin 250 mg Capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2011-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/016/002", "product_name": "Flucloxacillin 500 mg capsules", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2011-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/016/003", "product_name": "Flucloxacillin 125mg/5ml Oral Solution", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2011-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/016/004", "product_name": "Flucloxacillin 250mg/5ml Oral Solution", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete application (stand-alone) - Council Directive 81/851/EEC" }, { "licence_number": "PA1418/018/001", "product_name": "Calasu 2 mg prolonged-release tablets", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2026-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/020/001", "product_name": "Kapake 15mg/500mg Tablets", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/020/002", "product_name": "Kapake 30 mg/500 mg Tablets", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1993-10-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/021/001", "product_name": "Azactam 1 g Powder for Solution for Injection or Infusion", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1985-03-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DF", "J01DF01" ], "active_substances": [ "Aztreonam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1418/021/002", "product_name": "Azactam 2 g Powder for Solution for Injection or Infusion", "holder": "Athlone Pharmaceuticals Limited", "authorised_date": "1985-03-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DF", "J01DF01" ], "active_substances": [ "Aztreonam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/001/001", "product_name": "Mirtazapine Bluefish 15 mg orodispersible tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2008-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/001/002", "product_name": "Mirtazapine Bluefish 30 mg orodispersible tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2008-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/001/003", "product_name": "Mirtazapine Bluefish 45 mg orodispersible tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2008-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/002/002", "product_name": "Co-amoxiclav Bluefish 500 mg/125 mg film- coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Clavulanic acid", "Amoxicillin trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/002/003", "product_name": "Co-amoxiclav Bluefish 875 mg/125 mg film- coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Clavulanic acid", "Amoxicillin trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/003/001", "product_name": "Simvastatin Bluefish 10 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2008-11-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/003/002", "product_name": "Simvastatin Bluefish 20mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2008-11-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/003/003", "product_name": "Simvastatin Bluefish 40mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2008-11-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/004/001", "product_name": "Alendronic Acid Bluefish Once weekly 70 mg tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-04-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Sodium alendronate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/005/001", "product_name": "Valaciclovir Bluefish 500 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB11" ], "active_substances": [ "Valaciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/006/001", "product_name": "Venlablue XL 75 mg prolonged-release capsules, hard", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/006/002", "product_name": "Venlablue XL 150mg Prolonged Release Capsules, Hard", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/007/001", "product_name": "Omeprazole Bluefish 10 mg gastro-resistant capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/007/002", "product_name": "Omeprazole Bluefish 20 mg gastro-resistant capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/007/003", "product_name": "Omeprazole Bluefish 40 mg gastro-resistant capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/008/001", "product_name": "Pantoprazole Bluefish 20 mg gastro-resistant tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/008/002", "product_name": "Pantoprazole Bluefish 40 mg gastro-resistant tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/009/001", "product_name": "Metformin Bluefish 500 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/009/002", "product_name": "Metformin Bluefish 850 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/009/003", "product_name": "Metformin Bluefish 1000 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2009-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/013/001", "product_name": "Letrozole Bluefish 2.5 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/016/001", "product_name": "Amlodipine Bluefish 5 mg tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/016/002", "product_name": "Amlodipine Bluefish 10 mg tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/017/001", "product_name": "Risedronate Bluefish Once a Week 35 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2011-03-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA07" ], "active_substances": [ "Risedronate sodium hemipentahydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/021/001", "product_name": "Sertraline Bluefish 50 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2013-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/021/002", "product_name": "Sertraline Bluefish 100 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2013-05-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/023/001", "product_name": "Escitalopram Bluefish 5 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2014-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/023/002", "product_name": "Escitalopram Bluefish 10 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2014-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/023/003", "product_name": "Escitalopram Bluefish 15 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2014-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/023/004", "product_name": "Escitalopram Bluefish 20 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2014-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/027/001", "product_name": "Atorvastatin Bluefish 10 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/027/002", "product_name": "Atorvastatin Bluefish 20 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/027/003", "product_name": "Atorvastatin Bluefish 30 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/027/004", "product_name": "Atorvastatin Bluefish 40 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/027/005", "product_name": "Atorvastatin Bluefish 60 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/027/006", "product_name": "Atorvastatin Bluefish 80 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/029/001", "product_name": "Amorolfine 5% w/v medicated nail lacquer", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2013-06-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated nail lacquer", "atc_codes": [ "D01AE16" ], "active_substances": [ "Amorolfine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/030/001", "product_name": "Doxycycline Bluefish 100 mg Capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2010-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA", "J01AA02" ], "active_substances": [ "Doxycycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/031/001", "product_name": "Modafinil Bluefish 100 mg tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2015-06-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA07" ], "active_substances": [ "Modafinil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/031/002", "product_name": "Modafinil Bluefish 200 mg tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2015-06-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA07" ], "active_substances": [ "Modafinil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/032/001", "product_name": "Montelukast Bluefish 10 mg Film-coated Tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2021-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/033/001", "product_name": "Montelukast Bluefish 4 mg chewable tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2021-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/033/002", "product_name": "Montelukast Bluefish 5 mg chewable tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2021-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/039/001", "product_name": "Mybufen 200 mg Film-coated Tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/039/002", "product_name": "Mybufen Max 400 mg Film-coated Tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/040/001", "product_name": "Paracetamol 500 mg tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2022-09-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/041/001", "product_name": "Sunitinib Bluefish 12.5 mg hard capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX01" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/041/002", "product_name": "Sunitinib Bluefish 25 mg hard capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX01" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/041/003", "product_name": "Sunitinib Bluefish 50 mg hard capsules", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX01" ], "active_substances": [ "Sunitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/042/001", "product_name": "Zitrease Allergy 10 mg Film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2004-02-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/044/001", "product_name": "Rivaroxaban Bluefish 10 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/044/002", "product_name": "Rivaroxaban Bluefish 15 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/044/003", "product_name": "Rivaroxaban Bluefish 20 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/044/004", "product_name": "Rivaroxaban Bluefish 15 mg film-coated tablets Rivaroxaban Bluefish 20 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/045/001", "product_name": "Mirtazapine Bluefish 15 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/045/002", "product_name": "Mirtazapine Bluefish 30 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/045/003", "product_name": "Mirtazapine Bluefish 45 mg 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"Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/047/001", "product_name": "Meladura 2 mg prolonged-release tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/049/001", "product_name": "Ticagrelor Bluefish 60 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1436/049/002", "product_name": "Ticagrelor Bluefish 90 mg film-coated tablets", "holder": "Bluefish Pharmaceuticals AB", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1441/002/002", "product_name": "Monuril 3 g granules for oral solution", "holder": "Zambon S.p.A.", "authorised_date": "1995-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "J01XX", "J01XX01" ], "active_substances": [ "Fosfomycin trometamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/015/001", "product_name": "MONTELUKAST 10 mg Film-Coated Tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/015/003", "product_name": "MONTELUKAST Paediatric 5 mg Chewable Tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2012-06-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/016/001", "product_name": "Vedixal XL 75 mg prolonged release capsules, hard", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2015-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/016/002", "product_name": "Vedixal XL 150mg Prolonged release capsules, hard", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2015-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/017/001", "product_name": "Romax Once Weekly 70mg Tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/018/001", "product_name": "Alfu 10 mg Prolonged-release Tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2014-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA01" ], "active_substances": [ "Alfuzosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/019/001", "product_name": "Fintrid 5 mg film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2008-06-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04CB", "G04CB01" ], "active_substances": [ "Finasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/020/001", "product_name": "Gabin 100 mg capsules, hard", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/020/002", "product_name": "Gabin 300 mg capsules, hard", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/020/003", "product_name": "Gabin 400 mg capsules, hard", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/021/001", "product_name": "Metformin Aurobindo 500 mg film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/021/002", "product_name": "Metformin Aurobindo 850 mg film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/021/003", "product_name": "Metformin Aurobindo 1000 mg film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/022/001", "product_name": "Cefuroxime Aurobindo 250mg Film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2015-10-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DC02" ], "active_substances": [ "Cefuroxime axetil (amorphous)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/022/002", "product_name": "Cefuroxime Aurobindo 500mg Film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2015-10-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DC02" ], "active_substances": [ "Cefuroxime axetil (amorphous)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/023/001", "product_name": "Vertigon 8 mg tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2014-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA01" ], "active_substances": [ "Betahistine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/023/002", "product_name": "Vertigon 16 mg tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2014-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA01" ], "active_substances": [ "Betahistine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"PA1445/026/001", "product_name": "Gabapentin Auro 100 mg hard capsules", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2022-10-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/026/002", "product_name": "Gabapentin Auro 300 mg hard capsules", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2022-10-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1445/027/002", "product_name": "Apremilast Aurobindo 30mg film-coated tablets", "holder": "Aurobindo Pharma (Malta) Limited", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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Farma, S.A.", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1474/008/001", "product_name": "Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.02 mg/ 3 mg Film-coated Tablets", "holder": "Laboratorios Leon Farma, S.A.", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1474/008/002", "product_name": "Ethinylestradiol/Drospirenone Leon Farma & Placebo 0.03 mg/ 3 mg Film-coated Tablets", "holder": "Laboratorios Leon Farma, S.A.", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1474/011/001", "product_name": "Raener 2 mg/0.03 mg film-coated tablets", "holder": "Laboratorios Leon Farma, S.A.", "authorised_date": "2018-08-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA15" ], "active_substances": [ "Dienogest micronized", "Ethinylestradiol micronized" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1516/001/001", "product_name": "Dolenio 1500mg Film-coated tablets", "holder": "Blue Bio Pharmaceuticals Limited", "authorised_date": "2009-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Glucosamine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1519/001/001", "product_name": "Paracetamol Genmed 500 mg tablets", "holder": "Genmed B.V.", "authorised_date": "2010-06-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1543/002/001", "product_name": "Ryaltris 25 microgram/actuation + 600 microgram/actuation nasal spray, suspension", "holder": "Glenmark Pharmaceuticals s.r.o.", "authorised_date": "2021-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD59" ], "active_substances": [ "Mometasone furoate", "Olopatadine" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1548/002/001", "product_name": "Monovo 1 mg/g Cream", "holder": "Almirall Hermal GmbH", "authorised_date": "2011-11-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AC", "D07AC13" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1555/001/001", "product_name": "Medikinet MR 5mg modified – release capsules, hard", "holder": "Medice Arzneimittel Putter GmbH & Co. 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K.G", "authorised_date": "2011-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1555/001/005", "product_name": "Medikinet MR 40mg modified – release capsules, hard", "holder": "Medice Arzneimittel Putter GmbH & Co. K.G", "authorised_date": "2011-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride", "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1555/001/006", "product_name": "Medikinet 5 mg tablets", "holder": "Medice Arzneimittel Putter GmbH & Co. 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K.G", "authorised_date": "2011-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1555/001/008", "product_name": "Medikinet 20 mg tablets", "holder": "Medice Arzneimittel Putter GmbH & Co. K.G", "authorised_date": "2011-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/001/001", "product_name": "Buprenorphine 0.4 mg Sublingual Tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2010-12-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/001/002", "product_name": "Buprenorphine 2 mg Sublingual Tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2010-12-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/001/003", "product_name": "Buprenorphine 8 mg Sublingual Tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2010-12-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N07BC", "N07BC01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/002/001", "product_name": "Dexamethasone Activase 0.5 mg Tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2022-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/002/002", "product_name": "Dexamethasone Activase 2 mg Tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2022-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/003/001", "product_name": "Prednisolone 5 mg soluble tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2025-03-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Soluble tablet", "atc_codes": [ "H02AB06" ], "active_substances": [ "Prednisolone sodium phosphate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/004/001", "product_name": "Nitrofurantoin 50 mg hard capsules", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XE01" ], "active_substances": [ "Nitrofurantoin, macrocrystalline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/004/002", "product_name": "Nitrofurantoin 100 mg hard capsules", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XE01" ], "active_substances": [ "Nitrofurantoin, macrocrystalline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/006/002", "product_name": "Doxycycline 100 mg hard capsules", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA02" ], "active_substances": [ "Doxycycline hyclate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/007/001", "product_name": "Fluoxetine 10 mg hard capsule", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/007/002", "product_name": "Fluoxetine 20 mg hard capsule", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/007/003", "product_name": "Fluoxetine 30 mg hard capsule", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/007/004", "product_name": "Fluoxetine 40 mg hard capsule", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/007/005", "product_name": "Fluoxetine 60 mg hard capsule", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/008/001", "product_name": "Tranylcypromine 10 mg coated tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "N06AF04" ], "active_substances": [ "Tranylcypromine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/009/001", "product_name": "Metformin Activase 500 mg film-coated tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/009/002", "product_name": "Metformin Activase 850 mg film-coated tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1567/009/003", "product_name": "Metformin Activase 1000 mg film-coated tablets", "holder": "Activase Pharmaceuticals Limited", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1572/001/001", "product_name": "Bonasol Once Weekly 70 mg Oral Solution", "holder": "Xeolas Pharmaceuticals Limited", "authorised_date": "2011-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronate sodium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1572/002/001", "product_name": "Pedippi 2 mg/ml powder for oral suspension", "holder": "Xeolas Pharmaceuticals Limited", "authorised_date": "2019-11-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1572/002/002", "product_name": "Pedippi 4 mg/ml powder for oral suspension", "holder": "Xeolas Pharmaceuticals Limited", "authorised_date": "2019-11-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1591/003/001", "product_name": "Amsalyo 75 mg powder for concentration for solution infusion", "holder": "Eurocept International BV", "authorised_date": "2024-01-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01XX01" ], "active_substances": [ "Amsacrine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1610/001/001", "product_name": "Meropenem 500 mg powder for solution for injection or infusion", "holder": "Venus Pharma GmbH", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "anhydrous meropenem" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1610/001/002", "product_name": "Meropenem 1 g powder for solution for injection or infusion", "holder": "Venus Pharma GmbH", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1613/001/001", "product_name": "Azzalure, 125 Speywood units, powder for solution for injection", "holder": "Ipsen Pharma", "authorised_date": "2010-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX", "M03AX01" ], "active_substances": [ "Clostridium botulinum toxin type a haemagglutinin complex" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1613/002/001", "product_name": "Dysport 500 units Powder for solution for injection", "holder": "Ipsen Pharma", "authorised_date": "1994-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J06AA", "J06AA04" ], "active_substances": [ "Clostridium botulinum toxin type a haemagglutinin complex" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1613/002/002", "product_name": "Dysport 300 units Powder for solution for injection", "holder": "Ipsen Pharma", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Botulinum toxin type A - haemagglutinin complex" ], "routes": [ "Intradermal use", "Intramuscular use", "Intravesical use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1613/004/001", "product_name": "Alluzience, 200 Speywood units/mL, solution for injection", "holder": "Ipsen Pharma", "authorised_date": "2021-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Botulinum Toxin A - Haemagglutinin Complex" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1613/005/001", "product_name": "Relfydess, 100 units/mL, solution for injection", "holder": "Ipsen Pharma", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1618/001/001", "product_name": "Pantoprazole 40 mg Powder for Solution for Injection", "holder": "Laboratorio Reig Jofre, S.A.", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/001/001", "product_name": "Betnesol 0.1% w/v Eye, Ear and Nasal Drops, solution", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear/eye/nasal drops, solution", "atc_codes": [ "S02BA", "S02BA07" ], "active_substances": [ "BETAMETHASONE SODIUM PHOSPHATE" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/002/001", "product_name": "Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal Drops, solution", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1993-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear/eye/nasal drops, solution", "atc_codes": [ "S03CA", "S03CA06" ], "active_substances": [ "Neomycin sulfate", "BETAMETHASONE SODIUM PHOSPHATE" ], "routes": [ "Auricular use", "Nasal use", "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/004/001", "product_name": "Neo-Cytamen 1000 micrograms/ml Solution for Injection", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1995-05-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B03BA", "B03BA03" ], "active_substances": [ "Hydroxocobalamin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/005/001", "product_name": "Cocois Ointment, coal tar 12.0% sulphur for external use 4.0%, salicylic acid 2.0%", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1996-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D11AC", "D11AC08" ], "active_substances": [ "Coal tar solution", "Sulphur for external use", "Salicylic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/006/001", "product_name": "Trandate 5 mg/ml Solution for Injection", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1993-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C07AG", "C07AG01" ], "active_substances": [ "Labetalol hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/006/002", "product_name": "Trandate 100mg Film-Coated Tablets", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1993-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AG", "C07AG01" ], "active_substances": [ "Labetalol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/006/003", "product_name": "Trandate 200mg Film-coated Tablets", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1993-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AG", "C07AG01" ], "active_substances": [ "Labetalol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1638/009/001", "product_name": "Bettamousse 1 mg/g (0.1%) cutaneous foam", "holder": "RPH Pharmaceuticals AB", "authorised_date": "1998-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous foam", "atc_codes": [ "D07AC", "D07AC01" ], "active_substances": [ "Betamethasone valerate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1676/002/001", "product_name": "Fentadur 25 micrograms/hour Transdermal Patch", "holder": "Lavipharm S.A.", "authorised_date": "2012-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1676/002/002", "product_name": "Fentadur 50 micrograms/hour Transdermal Patch", "holder": "Lavipharm S.A.", "authorised_date": "2012-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1676/002/003", "product_name": "Fentadur 75 micrograms/hour Transdermal Patch", "holder": "Lavipharm S.A.", "authorised_date": "2012-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1676/002/004", "product_name": "Fentadur 100 micrograms/hour Transdermal Patch", "holder": "Lavipharm S.A.", "authorised_date": "2012-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1676/002/005", "product_name": "Fentadur 12 micrograms/hour transdermal patch", "holder": "Lavipharm S.A.", "authorised_date": "2012-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1677/007/007", "product_name": "Mycostatin 100,000 units/ml Oral Suspension (Ready Mixed)", "holder": "Substipharm", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A07AA", "A07AA02" ], "active_substances": [ "Nystatin" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1677/008/001", "product_name": "Iverscab 3 mg tablets", "holder": "Substipharm", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "P02CF01" ], "active_substances": [ "Ivermectin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/001", "product_name": "Adizem-SR 90 mg Prolonged Release Capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/002", "product_name": "Adizem-SR 120 mg Prolonged Release Capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/003", "product_name": "Adizem-SR 180 mg Prolonged Release Capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/004", "product_name": "ADIZEM-XL 120mg prolonged release capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1994-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/005", "product_name": "ADIZEM-XL 180mg prolonged release capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1994-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/006", "product_name": "ADIZEM-XL 240 mg prolonged release capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1994-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/001/007", "product_name": "ADIZEM-XL 300 mg prolonged release capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1994-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C08DB", "C08DB01" ], "active_substances": [ "Diltiazem hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/002/001", "product_name": "BuTrans 5 micrograms/hour transdermal patch", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2005-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/002/002", "product_name": "BuTrans 10 micrograms/hour transdermal patch", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2005-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/002/003", "product_name": "BuTrans 20 micrograms/hour transdermal patch", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2005-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/002/004", "product_name": "BuTrans 15 microgram/hour transdermal patch", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2015-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/004/001", "product_name": "MST Continus 5 mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1993-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/004/002", "product_name": "MST Continus 10 mg Prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1982-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/004/003", "product_name": "MST Continus 15 mg Prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1993-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/004/004", "product_name": "MST Continus 30 mg Prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1982-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/004/006", "product_name": "MST Continus 100mg Prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1983-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/005/001", "product_name": "OxyContin 5 mg prolonged release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2002-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/005/002", "product_name": "OxyContin 10 mg prolonged release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1998-05-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/005/003", "product_name": "OxyContin 20 mg prolonged release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1998-05-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/005/004", "product_name": "OxyContin 40 mg prolonged release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1998-05-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/005/005", "product_name": "OxyContin 80 mg prolonged release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1998-05-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/001", "product_name": "OxyNorm 10 mg/ml, solution for injection or infusion", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2006-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/002", "product_name": "OxyNorm liquid 1 mg/ml oral solution", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/003", "product_name": "OxyNorm concentrate 10 mg/ml oral solution", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/004", "product_name": "OxyNorm 5 mg hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/005", "product_name": "OxyNorm 10 mg hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/006", "product_name": "OxyNorm 20 mg hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/007", "product_name": "OxyNorm Dispersa 5 mg Orodispersible Tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2010-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/008", "product_name": "OxyNorm Dispersa 10 mg Orodispersible Tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2010-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/009", "product_name": "OxyNorm Dispersa 20 mg orodispersible tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2010-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/006/010", "product_name": "OxyNorm 50 mg/ml, solution for injection or infusion", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2011-09-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/007/001", "product_name": "Palladone 1.3 mg hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1995-12-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/007/002", "product_name": "Palladone 2.6 mg hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1995-12-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/007/007", "product_name": "Palladone SR 2 mg prolonged release hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1995-12-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N02AA", "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/007/008", "product_name": "Palladone SR 4 mg prolonged release hard capsules", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1993-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N02AA", "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/007/009", "product_name": "Palladone SR 8 mg prolonged release hard capsules,", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1993-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N02AA", "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/009/001", "product_name": "Sevredol 10mg Film-Coated Tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1989-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/009/002", "product_name": "Sevredol 20 mg Film-Coated Tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "1989-11-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/010/001", "product_name": "Targin 5 mg/2.5 mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2009-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/010/002", "product_name": "Targin 10mg/5mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/010/003", "product_name": "Targin 20mg/10mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/010/004", "product_name": "Targin 40 mg/20 mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2009-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/010/006", "product_name": "Targin 15 mg/7.5 mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2014-01-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/010/007", "product_name": "Targin 30 mg/15 mg prolonged-release tablets", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2014-01-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA", "N02AA55" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/013/001", "product_name": "Flutiform 50 microgram/5 microgram per metered dose pressurised inhalation, suspension", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2012-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/013/002", "product_name": "Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2012-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1688/013/003", "product_name": "Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension", "holder": "Mundipharma Pharmaceuticals Limited", "authorised_date": "2012-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/001/001", "product_name": "Lanoxin 500 micrograms/2 ml Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01AA", "C01AA05" ], "active_substances": [ "Digoxin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/001/002", "product_name": "Lanoxin PG 50 micrograms/ml Elixir", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C01AA", "C01AA05" ], "active_substances": [ "Digoxin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/001/003", "product_name": "Lanoxin PG 62.5 microgram Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01AA", "C01AA05" ], "active_substances": [ "Digoxin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/001/004", "product_name": "Lanoxin 250 microgram Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01AA", "C01AA05" ], "active_substances": [ "Digoxin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/002/001", "product_name": "Zyloric 100 mg tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/002/002", "product_name": "Zyloric 300 mg tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1981-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], "active_substances": [ "Allopurinol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/003/002", "product_name": "Imuran 25 mg Film-coated Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1987-07-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX", "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/003/003", "product_name": "Imuran 50 mg Film-coated Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX", "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/004/001", "product_name": "Alkeran 50 mg Powder and Solvent for Solution for Infusion", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2002-10-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "L01AA", "L01AA03" ], "active_substances": [ "Melphalan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/004/002", "product_name": "Alkeran 2 mg Film-coated Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01AA", "L01AA03" ], "active_substances": [ "Melphalan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/005/001", "product_name": "Kemadrin 5 mg Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04AA", "N04AA04" ], "active_substances": [ "Procyclidine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/006/001", "product_name": "Lanvis 40mg Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01BB", "L01BB03" ], "active_substances": [ "Tioguanine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/007/001", "product_name": "Leukeran 2 mg film-coated tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01AA", "L01AA02" ], "active_substances": [ "Chlorambucil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/008/001", "product_name": "Myleran 2 mg film-coated tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01AB", "L01AB01" ], "active_substances": [ "Busulfan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/009/001", "product_name": "Puri-Nethol 50 mg Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01BB", "L01BB02" ], "active_substances": [ "Mercaptopurine monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/010/001", "product_name": "Septrin 80 mg/400 mg Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1975-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EE", "J01EE01" ], "active_substances": [ "Sulfamethoxazole", "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/010/002", "product_name": "Septrin Forte 160 mg/800 mg Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1977-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EE", "J01EE01" ], "active_substances": [ "Sulphamethoxazole", "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/010/003", "product_name": "Septrin Paediatric 40 mg/200 mg per 5 ml Oral Suspension", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1975-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J01EE", "J01EE01" ], "active_substances": [ "Sulphamethoxazole", "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/010/004", "product_name": "Septrin Adult 80 mg/400 mg per 5 ml Oral Suspension", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1975-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J01EE", "J01EE01" ], "active_substances": [ "Sulphamethoxazole", "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/010/005", "product_name": "Septrin 80 mg/400 mg per ampoule, concentrate for solution for infusion", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1975-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J01EE01" ], "active_substances": [ "Sulfamethoxazole", "Trimethoprim" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/001", "product_name": "Oroxine 25 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/002", "product_name": "Oroxine 50 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/003", "product_name": "Oroxine 75 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/004", "product_name": "Oroxine 100 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/005", "product_name": "Oroxine 125 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/006", "product_name": "Oroxine 150 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/007", "product_name": "Oroxine 175 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/013/008", "product_name": "Oroxine 200 microgram tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/014/001", "product_name": "Dexamethasone 2mg Tablets", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/017/001", "product_name": "Ovestin 1 mg per gram Vaginal Cream", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1993-08-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G03CA", "G03CA04" ], "active_substances": [ "Estriol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/022/001", "product_name": "Diprivan 1% w/v emulsion for injection or infusion, pre-filled syringe", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1995-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/023/001", "product_name": "EMLA 5% w/w Cream", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2017-09-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "N01BB", "N01BB20" ], "active_substances": [ "Lidocaine", "Prilocaine" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/024/001", "product_name": "Marcain Polyamp Steripack 0.25% w/v Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1988-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/024/002", "product_name": "Marcain Polyamp Steripack 0.5% w/v Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1988-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/024/003", "product_name": "Marcain Heavy Steripack 0.5% w/v Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1987-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/025/001", "product_name": "Marcain 0.25% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1988-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB51" ], "active_substances": [ "Bupivacaine hydrochloride", "Adrenaline tartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/025/002", "product_name": "Marcain 0.5% w/v with Adrenaline (Epinephrine, 5 micrograms per ml) (1:200,000) Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1988-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB51" ], "active_substances": [ "Adrenaline tartrate", "Bupivacaine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/027/001", "product_name": "Xylocaine 2% with Adrenaline (Epinephrine) (1:200,000) Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Lidocaine hydrochloride", "Adrenaline" ], "routes": [ "Infiltration" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1691/028/001", "product_name": "Xylocaine 10 mg/delivered dose Mucosal Spray", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1691/029/001", "product_name": "Tracrium 10 mg/ml, solution for injection or infusion, ampoules", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1983-09-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC04" ], "active_substances": [ "Atracurium besilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/029/002", "product_name": "Tracrium 10 mg/ml solution for injection or infusion, vials", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2010-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC04" ], "active_substances": [ "Atracurium besilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/030/001", "product_name": "Nimbex 2 mg/ml solution for injection/infusion", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1996-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC11" ], "active_substances": [ "Cisatracurium Besilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/031/001", "product_name": "Mivacron 2 mg/ml Solution for Injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1995-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "M03AC", "M03AC10" ], "active_substances": [ "Mivacurium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/032/001", "product_name": "Ultiva 1 mg Powder for Concentrate for Solution for Infusion", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1999-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/032/002", "product_name": "Ultiva 2 mg Powder for Concentrate for Solution for Infusion", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1999-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/032/003", "product_name": "Ultiva 5 mg Powder for Concentrate for Solution for Infusion", "holder": "Aspen Pharma Trading Limited", "authorised_date": "1999-05-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/034/001", "product_name": "Fondaparinux Sodium Aspen 1.5 mg/0.3 ml solution for injection, pre-filled syringe", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AX05" ], "active_substances": [ "Fondaparinux sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/034/002", "product_name": "Fondaparinux sodium Aspen 2.5 mg/0.5 ml solution for injection, pre-filled syringe.", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AX05" ], "active_substances": [ "Fondaparinux sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/034/003", "product_name": "Fondaparinux sodium Aspen 5 mg/0.4 ml solution for injection, pre-filled syringe.", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AX05" ], "active_substances": [ "Fondaparinux sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/034/004", "product_name": "Fondaparinux sodium Aspen 7.5 mg/0.6 ml solution for injection, pre-filled syringe.", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AX05" ], "active_substances": [ "Fondaparinux sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/034/005", "product_name": "Fondaparinux sodium Aspen 10 mg/0.8 ml solution for injection, pre-filled syringe.", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2022-07-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AX05" ], "active_substances": [ "Fondaparinux sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/036/001", "product_name": "Sugammadex Aspen 100 mg/mL solution for injection", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1691/037/001", "product_name": "Xylocaine 20mg/g Gel", "holder": "Aspen Pharma Trading Limited", "authorised_date": "2026-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/002/001", "product_name": "Latanoprost/Timolol Zentiva 50 microgram/ml + 5 mg/ml eye drops solution", "holder": "Zentiva k.s.", "authorised_date": "2013-05-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED51" ], "active_substances": [ "Latanoprost", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/003/001", "product_name": "Mubucho 16 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/003/002", "product_name": "Mubucho 40 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/003/003", "product_name": "Mubucho 55 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/003/004", "product_name": "Mubucho 63 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/003/005", "product_name": "Mubucho 79 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/003/006", "product_name": "Mubucho 111 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2022-11-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/004/001", "product_name": "Gamanil 70mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "1984-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA", "N06AA07" ], "active_substances": [ "Lofepramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/009/001", "product_name": "Ezetimibe/Atorvastatin Zentiva 10 mg/10 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/009/002", "product_name": "Ezetimibe/Atorvastatin Zentiva 10 mg/20 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" 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"Tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/010/004", "product_name": "Bisoprolol Zentiva 5mg tablets", "holder": "Zentiva k.s.", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/010/005", "product_name": "Bisoprolol Zentiva 7.5mg tablets", "holder": "Zentiva k.s.", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/010/006", "product_name": "Bisoprolol Zentiva 10 mg tablets", "holder": "Zentiva k.s.", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/011/001", "product_name": "Bosentan Zentiva 62.5 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX01" ], "active_substances": [ "Bosentan monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/011/002", "product_name": "Bosentan Zentiva 125 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX01" ], "active_substances": [ "Bosentan monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/012/001", "product_name": "Edoxaban Zentiva 15 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/012/002", "product_name": "Edoxaban Zentiva 30 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/012/003", "product_name": "Edoxaban Zentiva 60 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/013/001", "product_name": "Lirepin 400 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2025-05-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen lysine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/016/001", "product_name": "Maxeeze Effervescent Tablets Paracetamol 500 mg Codeine Phosphate Hemihydrate 8 mg Caffeine 30 mg", "holder": "Zentiva k.s.", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Codeine phosphate bp", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/018/001", "product_name": "Enzalutamide Zentiva 40 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1701/018/002", "product_name": "Enzalutamide Zentiva 80 mg film-coated tablets", "holder": "Zentiva k.s.", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1714/001/001", "product_name": "Hidrasec 100 mg hard capsules", "holder": "Bioproject Europe Ltd", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A07XA", "A07XA04" ], "active_substances": [ "Racecadotril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1714/001/002", "product_name": "Hidrasec Infants 10mg Granules for Oral Suspension", "holder": "Bioproject Europe Ltd", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "A07XA", "A07XA04" ], "active_substances": [ "Racecadotril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1714/001/003", "product_name": "Hidrasec Children 30mg Granules for Oral Suspension", "holder": "Bioproject Europe Ltd", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "A07XA", "A07XA04" ], "active_substances": [ "Racecadotril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/004/001", "product_name": "Teedex Oral Solution Paracetamol 120 mg/5 ml Diphenhydramine Hydrochloride 12.5 mg/5 ml", "holder": "Phoenix Healthcare Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Diphenhydramine hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/005/001", "product_name": "Dozol Oral Solution Paracetamol 120 mg/5 ml Diphenhydramine Hydrochloride 12.5 mg/5 ml", "holder": "Phoenix Healthcare Ltd", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Diphenhydramine hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/001", "product_name": "Paralink 120 mg/5 ml Oral Solution", "holder": "Phoenix Healthcare Limited", "authorised_date": "1984-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/002", "product_name": "Paralink 180 mg suppositories", "holder": "Phoenix Healthcare Ltd", "authorised_date": "1988-12-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/003", "product_name": "Paralink 500 mg suppositories", "holder": "Phoenix Healthcare Ltd", "authorised_date": "1988-12-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/004", "product_name": "Paralink Six Plus Paracetamol 250 mg/5 ml oral solution", "holder": "Phoenix Healthcare Limited", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/005", "product_name": "Paralink 80 mg Suppositories", "holder": "Phoenix Healthcare Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/006", "product_name": "Paralink 125 mg Suppositories", "holder": "Phoenix Healthcare Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/006/007", "product_name": "Paralink 250 mg Suppositories", "holder": "Phoenix Healthcare Limited", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/007/001", "product_name": "Pedamed 100 mg/g Cream", "holder": "Phoenix Healthcare Limited", "authorised_date": "1986-08-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AE04" ], "active_substances": [ "Zinc undecylenate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1721/007/002", "product_name": "Pedamed 100 mg/g Cutaneous Powder", "holder": "Phoenix Healthcare Limited", "authorised_date": "1986-08-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous powder", "atc_codes": [ "D01AE", "D01AE04" ], "active_substances": [ "Zinc undecylenate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1732/003/001", "product_name": "Trebon 600 mg powder for oral solution", "holder": "Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "R05CB", "R05CB01" ], "active_substances": [ "Acetylcysteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1744/002/001", "product_name": "Trinomia 100 mg/20 mg/2.5 mg hard capsules", "holder": "Ferrer Internacional, S.A", "authorised_date": "2015-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10BX", "C10BX06" ], "active_substances": [ "Acetylsalicylic acid", "Ramipril", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1744/002/002", "product_name": "Trinomia 100 mg/20 mg/5 mg hard capsules", "holder": "Ferrer Internacional, S.A", "authorised_date": "2015-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10BX", "C10BX06" ], "active_substances": [ "Acetylsalicylic acid", "Ramipril", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1744/002/003", "product_name": "Trinomia 100 mg/20 mg/10 mg hard capsules", "holder": "Ferrer Internacional, S.A", "authorised_date": "2015-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10BX", "C10BX06" ], "active_substances": [ "Acetylsalicylic acid", "Ramipril", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1744/002/004", "product_name": "Trinomia 100 mg/40 mg/2.5 mg hard capsules", "holder": "Ferrer Internacional, S.A", "authorised_date": "2017-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10BX", "C10BX06" ], "active_substances": [ "Acetylsalicylic acid", "Ramipril", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1744/002/005", "product_name": "Trinomia 100 mg/40 mg/5 mg hard capsules", "holder": "Ferrer Internacional, S.A", "authorised_date": "2017-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10BX", "C10BX06" ], "active_substances": [ "Acetylsalicylic acid", "Ramipril", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1744/002/006", "product_name": "Trinomia 100 mg/40 mg/10 mg hard capsules", "holder": "Ferrer Internacional, S.A", "authorised_date": "2017-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10BX", "C10BX06" ], "active_substances": [ "Acetylsalicylic acid", "Ramipril", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/001/001", "product_name": "Imunovir 500 mg tablets", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "1983-11-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J05AX", "J05AX05" ], "active_substances": [ "Inosine acedoben dimepranol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/002/001", "product_name": "Magnence 243 mg powder for oral solution", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "2015-05-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A12CC", "A12CC05" ], "active_substances": [ "Magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/003/001", "product_name": "Catephen 10 % ointment", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "2015-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D06BB", "D06BB12" ], "active_substances": [ "Green tea dry extract" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/004/001", "product_name": "Magmedi 97 mg tablets", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A12CC04" ], "active_substances": [ "Magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/005/001", "product_name": "Metaperex 400 IU soft capsules", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11HA03" ], "active_substances": [ "Rrr alpha-tocoferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/006/001", "product_name": "Nitrofurantoin Kora Healthcare 50 mg hard capsules", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "2024-07-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XE01" ], "active_substances": [ "Nitrofurantoin Macrocrystalline EP" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1748/006/002", "product_name": "Nitrofurantoin Kora Healthcare 100 mg hard capsules", "holder": "Kora Corporation Limited trading as Kora Healthcare", "authorised_date": "2024-07-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01XE01" ], "active_substances": [ "Nitrofurantoin Macrocrystalline EP" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1760/001/001", "product_name": "Dacarbazine Lipomed 200 mg powder for solution for injection or infusion", "holder": "Lipomed GmbH", "authorised_date": "2012-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01AX", "L01AX04" ], "active_substances": [ "Dacarbazine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1760/001/002", "product_name": "Dacarbazine Lipomed 500 mg powder for solution for infusion", "holder": "Lipomed GmbH", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AX", "L01AX04" ], "active_substances": [ "Dacarbazine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1760/001/003", "product_name": "Dacarbazine Lipomed 1000 mg powder for solution for infusion", "holder": "Lipomed GmbH", "authorised_date": "2017-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AX", "L01AX04" ], "active_substances": [ "Dacarbazine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1770/001/001", "product_name": "Potassium iodide G.L. Pharma 65 mg tablets", "holder": "G.L. Pharma GmbH", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "V03AB", "V03AB21" ], "active_substances": [ "Potassium iodide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1770/002/001", "product_name": "Hydroxocobalamin 1 mg/ml solution for injection", "holder": "G.L. Pharma GmbH", "authorised_date": "2018-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B03BA", "B03BA03" ], "active_substances": [ "Hydroxocobalamin acetate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/001/002", "product_name": "Dacepton 5 mg/ml solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2014-05-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N04BC", "N04BC07" ], "active_substances": [ "Apomorphine hydrochloride hemihydrate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/001/003", "product_name": "Dacepton 10 mg/ml solution for injection in cartridge", "holder": "EVER Valinject GmbH", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "N04BC", "N04BC07" ], "active_substances": [ "Apomorphine hydrochloride hemihydrate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/002/001", "product_name": "Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2018-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N05CM", "N05CM18" ], "active_substances": [ "Dexmedetomidine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/004/001", "product_name": "Cabazitaxel EVER Pharma 10 mg/ml concentrate for solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2020-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CD04" ], "active_substances": [ "Cabazitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/005/001", "product_name": "Pemetrexed EVER Pharma 25 mg/ml concentrate for solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2021-01-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/006/001", "product_name": "Fulvestrant EVER Pharma 250 mg solution for injection in pre-filled syringe", "holder": "EVER Valinject GmbH", "authorised_date": "", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L02BA03" ], "active_substances": [ "Fulvestrant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/007/001", "product_name": "Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection", "holder": "EVER Valinject GmbH", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01BA04" ], "active_substances": [ "Terlipressin acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/008/001", "product_name": "Bortezomib 2.5 mg/ml solution for injection", "holder": "EVER Valinject GmbH", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/009/001", "product_name": "Eribulin EVER Pharma 0.44 mg/ml solution for injection", "holder": "EVER Valinject GmbH", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX41" ], "active_substances": [ "Eribulin Mesilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/010/001", "product_name": "Testosterone undecanoate EVER Pharma 1000 mg/4 ml solution for injection", "holder": "EVER Valinject GmbH", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03BA03" ], "active_substances": [ "Testosterone Undecanoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/011/001", "product_name": "Decitabine EVER Pharma 50 mg powder for concentrate for solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BC08" ], "active_substances": [ "Decitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/012/001", "product_name": "Carbetocin EVER Pharma 100 micrograms/ml solution for injection", "holder": "EVER Valinject GmbH", "authorised_date": "2026-08-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01BB03" ], "active_substances": [ "Carbetocin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/013/001", "product_name": "Trabectedin EVER Pharma 0.25 mg powder for concentrate for solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01CX01" ], "active_substances": [ "Trabectedin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1774/013/002", "product_name": "Trabectedin EVER Pharma 1 mg powder for concentrate for solution for infusion", "holder": "EVER Valinject GmbH", "authorised_date": "2026-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01CX01" ], "active_substances": [ "Trabectedin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1776/002/001", "product_name": "Cariban 10 mg/10 mg modified-release hard capsules", "holder": "Italfarmaco S.p.A.", "authorised_date": "2020-05-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "R06AA59" ], "active_substances": [ "DOXYLAMINE SUCCINATE", "Pyridoxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1777/001/001", "product_name": "Mysoline 250mg Tablets", "holder": "Laboratoires SERB", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AA", "N03AA03" ], "active_substances": [ "Primidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/001/001", "product_name": "Bicalutamide Fair-Med 50 mg film-coated tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2012-09-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/001/002", "product_name": "Bicalutamide Fair-Med 150mg Film-coated Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2012-09-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/007/001", "product_name": "Carbidopa/Levodopa Fair-Med 12.5mg/50mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/007/002", "product_name": "Carbidopa/Levodopa Fair-Med 10 mg/100 mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/007/003", "product_name": "Carbidopa/Levodopa Fair-Med 25 mg/100 mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/007/004", "product_name": "Carbidopa/Levodopa Fair-Med 25 mg/250 mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/008/001", "product_name": "Telmisartan Fair-Med 20 mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/008/002", "product_name": "Telmisartan Fair-Med 40 mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1789/008/003", "product_name": "Telmisartan Fair-Med 80 mg Tablets", "holder": "Fairmed Healthcare GmbH", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1815/001/001", "product_name": "Combiprasal 0.5 mg/2.5 mg per 2.5 ml nebuliser solution", "holder": "Pharma Stulln GmbH", "authorised_date": "2014-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AL", "R03AL02" ], "active_substances": [ "Ipratropium bromide", "SALBUTAMOL SULFATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1815/002/001", "product_name": "Ketofall 0.25 mg/ml eye drops, solution in single-dose container", "holder": "Pharma Stulln GmbH", "authorised_date": "2016-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01GX", "S01GX08" ], "active_substances": [ "Ketotifen hydrogen fumarate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/002/001", "product_name": "Duodopa 20 mg/ml + 5 mg/ml intestinal gel", "holder": "AbbVie Limited", "authorised_date": "2005-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Intestinal gel", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/002/003", "product_name": "Produodopa 240 mg/ml + 12 mg/ml solution for infusion", "holder": "AbbVie Limited", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N04BA" ], "active_substances": [ "Foslevodopa", "Foscarbidopa" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/004/001", "product_name": "Sevorane 100% v/v Inhalation Gas", "holder": "AbbVie Limited", "authorised_date": "1995-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, liquid", "atc_codes": [ "N01AB", "N01AB08" ], "active_substances": [ "Sevoflurane" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/005/001", "product_name": "Zemplar 1 microgram capsules, soft", "holder": "AbbVie Limited", "authorised_date": "2008-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "H05BX", "H05BX02" ], "active_substances": [ "Paricalcitol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/005/002", "product_name": "Zemplar 2 micrograms capsules, soft", "holder": "AbbVie Limited", "authorised_date": "2008-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "H05BX", "H05BX02" ], "active_substances": [ "Paricalcitol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/005/004", "product_name": "Zemplar 5 micrograms/ml solution for injection", "holder": "AbbVie Limited", "authorised_date": "2005-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H05BX", "H05BX02" ], "active_substances": [ "Paricalcitol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/007/001", "product_name": "Alphagan 0.2% w/v (2 mg/ml) eye drops, solution", "holder": "AbbVie Limited", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EA05" ], "active_substances": [ "Brimonidine tartrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/008/001", "product_name": "FML 0.1% w/v Eye Drops Suspension", "holder": "AbbVie Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01BA", "S01BA07" ], "active_substances": [ "Fluorometholone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/010/001", "product_name": "Pred Forte 1% w/v, Eye Drops Suspension", "holder": "AbbVie Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01BA", "S01BA04" ], "active_substances": [ "Prednisolone acetate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/014/001", "product_name": "EXOCIN (Ofloxacin) 0.3% w/v Eye Drops Solution", "holder": "AbbVie Limited", "authorised_date": "1991-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AE", "S01AE01" ], "active_substances": [ "Ofloxacin" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/015/001", "product_name": "Acular 0.5% w/v Eye Drops, solution", "holder": "AbbVie Limited", "authorised_date": "1995-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01BC", "S01BC05" ], "active_substances": [ "Ketorolac trometamol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/016/001", "product_name": "Celluvisc 1% w/v Eye drops, solution, unit dose", "holder": "AbbVie Limited", "authorised_date": "1997-04-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carmellose sodium" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/016/002", "product_name": "Celluvisc 0.5 % w/v eye drops solution, unit dose", "holder": "AbbVie Limited", "authorised_date": "2006-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carmellose sodium" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/017/001", "product_name": "BOTOX 100 Allergan Units powder for solution for injection", "holder": "AbbVie Limited", "authorised_date": "2000-01-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "M03AX", "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/017/002", "product_name": "BOTOX 50 Allergan Units powder for solution for injection", "holder": "AbbVie Limited", "authorised_date": "2008-01-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX", "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/017/003", "product_name": "BOTOX 200 Allergan Units powder for solution for injection", "holder": "AbbVie Limited", "authorised_date": "2008-01-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX", "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/018/001", "product_name": "Relestat, 0.5 mg/ml, eye drops, solution", "holder": "AbbVie Limited", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX10" ], "active_substances": [ "Epinastine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/019/001", "product_name": "Combigan 2 mg/ml + 5 mg/ml eye drops, solution", "holder": "AbbVie Limited", "authorised_date": "2005-12-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Brimonidine tartrate", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1824/020/001", "product_name": "VISTABEL, 4 Allergan Units/0.1ml, Powder for solution for injection", "holder": "AbbVie Limited", "authorised_date": "2008-04-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX", "M03AX01" ], "active_substances": [ "Botulinum Toxin Type A" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/001/001", "product_name": "MultiHance, 0.5M solution for injection", "holder": "Bracco Imaging spa", "authorised_date": "1998-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA", "V08CA08" ], "active_substances": [ "Gadobenate dimeglumine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/001/002", "product_name": "MultiHance 529 mg/ml solution for injection in pre-filled syringe", "holder": "Bracco Imaging spa", "authorised_date": "2008-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V08CA", "V08CA08" ], "active_substances": [ "Gadobenate dimeglumine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/002/001", "product_name": "Maxibar 98.45% w/w powder for oral suspension", "holder": "Bracco Imaging spa", "authorised_date": "1992-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "V08BA", "V08BA01" ], "active_substances": [ "Barium sulfate" ], "routes": [ "Powder for oral/rectal suspension" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/004/003", "product_name": "Niopam 300, Solution for injection, glass bottles", "holder": "Bracco Imaging spa", "authorised_date": "1983-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB04" ], "active_substances": [ "Iopamidol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/004/005", "product_name": "Niopam 370, Solution for Injection, glass bottles", "holder": "Bracco Imaging spa", "authorised_date": "1983-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB04" ], "active_substances": [ "Iopamidol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/005/001", "product_name": "Gastromiro 612.4 mg/ml oral or rectal solution", "holder": "Bracco Imaging spa", "authorised_date": "1990-04-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral/rectal solution", "atc_codes": [ "V08AB", "V08AB04" ], "active_substances": [ "Iopamidol" ], "routes": [ "Oral use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/006/001", "product_name": "Iomeron 150 mgI/ml Solution for Injection", "holder": "Bracco Imaging spa", "authorised_date": "1999-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB10" ], "active_substances": [ "Iomeprol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/006/002", "product_name": "Iomeron 200 mgI/ml Solution for Injection", "holder": "Bracco Imaging spa", "authorised_date": "1999-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB10" ], "active_substances": [ "Iomeprol" ], "routes": [ "Intraarterial use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/006/003", "product_name": "Iomeron 250 mgI/ml Solution for Injection", "holder": "Bracco Imaging spa", "authorised_date": "1999-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB10" ], "active_substances": [ "Iomeprol" ], "routes": [ "Intraarterial use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/006/004", "product_name": "Iomeron 300 mgI/ml Solution for Injection", "holder": "Bracco Imaging spa", "authorised_date": "1999-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB10" ], "active_substances": [ "Iomeprol" ], "routes": [ "Intraarterial use", "Intraarticular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/006/005", "product_name": "Iomeron 350 mgI/ml Solution for Injection", "holder": "Bracco Imaging spa", "authorised_date": "1999-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB10" ], "active_substances": [ "Iomeprol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1826/006/006", "product_name": "Iomeron 400 mgI/ml Solution for Injection", "holder": "Bracco Imaging spa", "authorised_date": "1999-03-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08AB", "V08AB10" ], "active_substances": [ "Iomeprol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1832/001/002", "product_name": "Amoxicillin Centrient 500 mg hard capsules", "holder": "Centrient Pharmaceuticals Netherlands B.V", "authorised_date": "2013-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin (as trihydrate)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1843/001/001", "product_name": "Hydrex Surgical Scrub 4.0% w/v Cutaneous Solution", "holder": "Ecolab Deutschland GmbH", "authorised_date": "1995-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AC", "D08AC02" ], "active_substances": [ "Chlorhexidine gluconate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1843/002/001", "product_name": "Videne 7.5% w/w Surgical Scrub", "holder": "Ecolab Deutschland GmbH", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AG", "D08AG02" ], "active_substances": [ "Iodinated povidone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1843/002/002", "product_name": "Videne Antiseptic Solution 10% w/w Cutaneous Solution", "holder": "Ecolab Deutschland GmbH", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AG", "D08AG02" ], "active_substances": [ "Iodinated povidone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1843/002/003", "product_name": "Videne 10% w/w Alcoholic Tincture", "holder": "Ecolab Deutschland GmbH", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AG", "D08AG02" ], "active_substances": [ "Iodinated povidone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/001/001", "product_name": "Neophyr 1000 ppm mol/mol, medicinal gas, compressed", "holder": "SOL S.p.A.", "authorised_date": "2013-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "R07AX", "R07AX01" ], "active_substances": [ "Nitric oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/001/002", "product_name": "Neophyr 450 ppm mol/mol, medicinal gas, compressed", "holder": "SOL S.p.A.", "authorised_date": "2013-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "R07AX", "R07AX01" ], "active_substances": [ "Nitric oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/001/003", "product_name": "Neophyr 225 ppm mol/mol, medicinal gas, compressed", "holder": "SOL S.p.A.", "authorised_date": "2013-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "R07AX", "R07AX01" ], "active_substances": [ "Nitric oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/002/001", "product_name": "Medicinal air synthetic SOL 21.75% v/v medicinal gas, compressed", "holder": "SOL S.p.A.", "authorised_date": "2016-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/003/001", "product_name": "Donopa, 50 %/50 % v/v, medicinal gas, compressed", "holder": "SOL S.p.A.", "authorised_date": "2016-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "N01AX", "N01AX63" ], "active_substances": [ "Oxygen", "Nitrous oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/004/001", "product_name": "Nitrous oxide Medicinal SOL, 100 % v/v, medicinal gas, liquefied", "holder": "SOL S.p.A.", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, liquefied", "atc_codes": [ "N01AX", "N01AX13" ], "active_substances": [ "Nitrous oxide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/005/001", "product_name": "Liquid Medical Oxygen 100% Medicinal gas, cryogenic", "holder": "SOL S.p.A.", "authorised_date": "2018-05-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, cryogenic", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/005/002", "product_name": "Liquid Medical Oxygen 100% Medicinal gas, cryogenic", "holder": "SOL S.p.A.", "authorised_date": "2018-05-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicinal gas, cryogenic", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1848/005/003", "product_name": "Medical Oxygen 100% Medicinal gas, compressed", "holder": "SOL S.p.A.", "authorised_date": "2018-05-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1852/001/001", "product_name": "Pantoprazole Azevedos 40 mg powder for solution for injection/infusion", "holder": "Laboratorios Azevedos Industria Farmaceutica S.A.", "authorised_date": "2013-05-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1852/002/001", "product_name": "Esomeprazole Ticerin 40 mg powder for solution for injection or infusion", "holder": "Laboratorios Azevedos Industria Farmaceutica S.A.", "authorised_date": "2014-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1852/003/001", "product_name": "Aciclovir Azevedos 250 mg Powder for solution for infusion", "holder": "Laboratórios Azevedos - Indústria Farmacêutica S.A", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1852/004/001", "product_name": "Vancomycin 500 mg powder for concentrate for solution for infusion", "holder": "Laboratorios Azevedos Industria Farmaceutica S.A.", "authorised_date": "2016-04-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "Vancomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1852/004/002", "product_name": "Vancomycin 1000 mg powder for concentrate for solution for infusion", "holder": "Laboratorios Azevedos Industria Farmaceutica S.A.", "authorised_date": "2016-04-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "Vancomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1862/001/001", "product_name": "Rocuronium Bromide 10 mg/ml solution for Injection/Infusion", "holder": "Ibigen Srl", "authorised_date": "2011-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1862/002/001", "product_name": "Tranexamic Acid 100 mg/ml solution for injection/infusion", "holder": "Ibigen Srl", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B02AA", "B02AA02" ], "active_substances": [ "Tranexamic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1862/003/001", "product_name": "Flucloxacillin 250 mg Powder for solution for injection/infusion", "holder": "Ibigen Srl", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1862/003/002", "product_name": "Flucloxacillin 500 mg Powder for solution for injection/infusion", "holder": "Ibigen Srl", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1862/003/003", "product_name": "Flucloxacillin 1000 mg Powder for solution for injection/infusion", "holder": "Ibigen Srl", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1862/003/004", "product_name": "Flucloxacillin 2000 mg powder for solution for injection/infusion", "holder": "Ibigen Srl", "authorised_date": "2016-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1868/001/001", "product_name": "Vesanoid 10 mg soft capsules", "holder": "Cheplapharm Arzneimittel GmbH", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01XF01" ], "active_substances": [ "Tretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1868/002/001", "product_name": "Anexate 500 micrograms/5ml, solution for injection or infusion", "holder": "Cheplapharm Arzneimittel GmbH", "authorised_date": "1988-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AB", "V03AB25" ], "active_substances": [ "Flumazenil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/002/001", "product_name": "Altavita D3 50,000 IU oral solution", "holder": "Consilient Health Limited", "authorised_date": "2015-07-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/002/002", "product_name": "AltavitaD3 25,000IU oral solution", "holder": "Consilient Health Limited", "authorised_date": "2015-09-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/004/003", "product_name": "altavitaD3 25,000 IU soft capsules", "holder": "Consilient Health Limited", "authorised_date": "2016-09-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol (02)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/004/004", "product_name": "altavitaD3 50,000 IU soft capsules", "holder": "Consilient Health Limited", "authorised_date": "2016-09-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol (02)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/005/001", "product_name": "altavitaD3 1,000 IU soft capsules", "holder": "Consilient Health Limited", "authorised_date": "2016-09-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/005/002", "product_name": "altavitaD3 7,000 IU soft capsules", "holder": "Consilient Health Limited", "authorised_date": "2016-09-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/008/001", "product_name": "Colecalciferol 800 IU film-coated tablets", "holder": "Consilient Health Limited", "authorised_date": "2015-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"dosage_form": "Film-coated tablet", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/008/004", "product_name": "Colecalciferol 30000 IU film-coated tablets", "holder": "Consilient Health Limited", "authorised_date": "2015-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/026/001", "product_name": "Tapentadol Consilient Health 50 mg film-coated tablets", "holder": "Consilient Health Limited", "authorised_date": "2025-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1876/026/002", "product_name": "Tapentadol Consilient Health 75 mg film-coated tablets", "holder": "Consilient Health Limited", "authorised_date": "2025-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol 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"Clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins" ], "routes": [ "Intraglandular use", "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1907/001/003", "product_name": "XEOMIN 200 units powder for solution for injection", "holder": "Merz Pharmaceuticals GmbH", "authorised_date": "2016-07-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins" ], "routes": [ "Intraglandular use", "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1907/003/001", "product_name": "BOCOUTURE 50 units powder for solution for injection", "holder": "Merz Pharmaceuticals GmbH", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1907/003/002", "product_name": "BOCOUTURE 100 units powder for solution for injection", "holder": "Merz Pharmaceuticals GmbH", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1913/002/001", "product_name": "Cholurso 250 mg film-coated tablets", "holder": "Laboratoires Mayoly Spindler", "authorised_date": "2017-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1913/002/002", "product_name": "Cholurso 500 mg film-coated tablets", "holder": "Laboratoires Mayoly Spindler", "authorised_date": "2017-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1913/003/001", "product_name": "Transisoft 8.5 g powder for oral solution in sachet", "holder": "Laboratoires Mayoly Spindler", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution in sachet", "atc_codes": [ "A06AD", "A06AD15" ], "active_substances": [ "Macrogol 3350" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1913/004/001", "product_name": "Diabact UBT 50 mg tablets", "holder": "Laboratoires Mayoly Spindler", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "V04CX" ], "active_substances": [ "13c-urea" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1927/001/001", "product_name": "SimAlvia 60 mg/300 mg, soft capsules", "holder": "Laboratoires Galeniques Vernin", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A03AX", "A03AX58" ], "active_substances": [ "ALVERINE CITRATE", "Simeticone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1927/002/001", "product_name": "Spasmalvex 60 mg/300 mg, soft capsules", "holder": "Laboratoires Galeniques Vernin", "authorised_date": "2021-03-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A03AX58" ], "active_substances": [ "ALVERINE CITRATE", "Simeticone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1947/001/001", "product_name": "Piperacillin/Tazobactam 4g/0.5g powder for solution for infusion", "holder": "Stravencon Ltd", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1947/002/001", "product_name": "Cefuroxime 250 mg Powder for solution for injection", "holder": "Stravencon Ltd", "authorised_date": "2015-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1947/002/002", "product_name": "Cefuroxime 750 mg Powder for solution for injection", "holder": "Stravencon Ltd", "authorised_date": "2015-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1947/002/003", "product_name": "Cefuroxime 1500 mg Powder for solution for injection or infusion", "holder": "Stravencon Ltd", "authorised_date": "2015-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/009/001", "product_name": "Zoreeda 25 microgram/125 microgram per actuation pressurised inhalation, suspension", "holder": "Cipla Europe NV", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/009/002", "product_name": "Zoreeda 25 microgram/250 microgram per actuation pressurised inhalation, suspension", "holder": "Cipla Europe NV", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/012/001", "product_name": "Arquist 125 microgram per actuation pressurised inhalation, suspension", "holder": "Cipla Europe", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/012/002", "product_name": "Arquist 250 microgram per actuation pressurised inhalation, suspension", "holder": "Cipla Europe", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/013/001", "product_name": "Sereflo 25 microgram/125 microgram per actuation pressurised inhalation, suspension", "holder": "Cipla Europe NV", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/013/002", "product_name": "Sereflo 25 microgram/250 microgram per actuation pressurised inhalation, suspension", "holder": "Cipla Europe NV", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/014/001", "product_name": "Fexofast 120 mg Film-coated Tablets", "holder": "Cipla Europe NV", "authorised_date": "2011-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/014/002", "product_name": "Fexofast 180 mg Film-coated Tablets", "holder": "Cipla Europe NV", "authorised_date": "2011-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/015/001", "product_name": "Teriparatide Cipla 20 micrograms/80 microliters solution for injection in pre-filled syringe", "holder": "Cipla Europe", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/016/001", "product_name": "Pirfenidone Cipla 267 mg Film-coated Tablets", "holder": "Cipla Europe", "authorised_date": "2024-04-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/016/002", "product_name": "Pirfenidone Cipla 801 mg Film-coated Tablets", "holder": "Cipla Europe", "authorised_date": "2024-04-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/019/001", "product_name": "Rivaroxaban Azure 2.5 mg film-coated tablets", "holder": "Cipla Europe", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/019/002", "product_name": "Rivaroxaban Azure 10 mg film-coated tablets", "holder": "Cipla Europe", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/019/003", "product_name": "Rivaroxaban Azure 15 mg film-coated tablets", "holder": "Cipla Europe", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/019/004", "product_name": "Rivaroxaban Azure 20 mg film-coated tablets", "holder": "Cipla Europe", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/019/005", "product_name": "Rivaroxaban Azure 15 mg film-coated tablets Rivaroxaban Azure 20 mg film-coated tablets", "holder": "Cipla Europe", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1963/020/001", "product_name": "Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser solution", "holder": "Cipla Europe", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AK", "R03AK04" ], "active_substances": [ "Ipratropium bromide monohydrate", "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1966/001/001", "product_name": "ASACARD 162.5 mg prolonged release hard capsules", "holder": "New Haven Pharma (UK) Limited", "authorised_date": "1999-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "B01AC", "B01AC06" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1968/001/001", "product_name": "Noradrenaline (Norepinephrine) 0.08 mg/mL solution for infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "C01CA", "C01CA03" ], "active_substances": [ "Noradrenaline tartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/002/001", "product_name": "Adrenaline (Epinephrine) 1 mg/10 ml (1:10,000) Solution for Injection in Pre-Filled Syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Adrenaline tartrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/003/001", "product_name": "Atropine Sulfate Aguettant 0.1 mg/ml solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2015-10-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A03BA", "A03BA01" ], "active_substances": [ "Atropine Sulfate Monohydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/003/002", "product_name": "Atropine Sulfate Aguettant 0.2mg/ml Solution for Injection in Pre-Filled Syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2015-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A03BA", "A03BA01" ], "active_substances": [ "Atropine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/006/001", "product_name": "Junyelt, Concentrate for solution for infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2017-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA31" ], "active_substances": [ "Zinc gluconate", "Copper gluconate", "Manganese Gluconate", "Potassium iodide", "Sodium selenite" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/007/001", "product_name": "Phenylephrine 50 micrograms/ml, solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2015-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01CA", "C01CA06" ], "active_substances": [ "Phenylephrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/007/002", "product_name": "Phenylephrine 100 micrograms/ml solution for injection/infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2020-02-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C01CA06" ], "active_substances": [ "Phenylephrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/009/001", "product_name": "Lidocaine 10 mg/ml (1% w/v) solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2018-07-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N01BB", "N01BB02" ], "active_substances": [ "Lidocaine hydrochloride" ], "routes": [ "Infiltration" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/009/002", "product_name": "Lidocaine 20 mg/ml (2% w/v) solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2018-07-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N01BB", "N01BB02" ], "active_substances": [ "Lidocaine hydrochloride" ], "routes": [ "Infiltration" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/010/001", "product_name": "Murexal 10 mg/mL solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2020-04-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M03AB", "M03AB01" ], "active_substances": [ "Suxamethonium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/011/001", "product_name": "Ephedrine Hydrochloride 3 mg/ml solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/011/002", "product_name": "Ephedrine Hydrochloride 3 mg/ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2024-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/011/003", "product_name": "Ephedrine Hydrochloride 30 mg/ ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2024-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/012/001", "product_name": "Lidocaine hydrochloride 20 mg/ml, solution for injection/infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2020-11-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Infiltration", "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/013/001", "product_name": "Mykronor 5 micrograms/ml, solution for injection/infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C01CA03" ], "active_substances": [ "Noradrenaline tartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/015/001", "product_name": "Rocuronium bromide 10 mg/mL solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/016/001", "product_name": "Sugammadex 10 mg/ml solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/016/002", "product_name": "Sugammadex 50 mg/ml solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/017/001", "product_name": "Midazolam 1 mg/ml solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/017/002", "product_name": "Midazolam 1 mg/ml solution for injection/infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Intramuscular use", "Intravenous use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/017/003", "product_name": "Midazolam 5 mg/ml solution for injection/infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Intramuscular use", "Intravenous use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/018/001", "product_name": "0.9% Sodium Chloride Intravenous Infusion Solution", "holder": "Laboratoire Aguettant", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1968/019/001", "product_name": "5% Glucose Intravenous Infusion Solution", "holder": "Laboratoire Aguettant", "authorised_date": "1999-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA1968/020/001", "product_name": "Hartmann's Solution Compound Sodium Lactate Intravenous Infusion BP", "holder": "Laboratoire Aguettant", "authorised_date": "2007-05-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Calcium chloride dihydrate", "Potassium chloride", "Sodium lactate solution 60%" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/021/001", "product_name": "Paracetamol 10 mg/ml Solution for Infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2011-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/023/001", "product_name": "Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion", "holder": "Laboratoire Aguettant", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA03" ], "active_substances": [ "Noradrenaline tartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/024/001", "product_name": "Metaraminol 0.5mg/ ml Solution for injection in pre-filled syringe", "holder": "Laboratoire Aguettant", "authorised_date": "2026-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01CA09" ], "active_substances": [ "Metaraminol bitartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/025/001", "product_name": "Bupivacaine Heavy 5 mg/ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB01" ], "active_substances": [ "Bupivacaine hydrochloride monohydrate" ], "routes": [ "Intrathecal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/026/001", "product_name": "Droperidol 1.25 mg/ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AD08" ], "active_substances": [ "Droperidol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/026/002", "product_name": "Droperidol 2.5 mg/ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AD08" ], "active_substances": [ "Droperidol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/027/001", "product_name": "Lidocaine/Adrenaline (Epinephrine) 10 mg/ml + 5 microgram/ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB52" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate", "Adrenaline tartrate" ], "routes": [ "Epidural use", "Infiltration", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1968/027/002", "product_name": "Lidocaine/Adrenaline (Epinephrine) 20 mg/ml + 5 microgram/ml solution for injection", "holder": "Laboratoire Aguettant", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB52" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate", "Adrenaline tartrate" ], "routes": [ "Epidural use", "Infiltration", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1972/001/001", "product_name": "Fomicyt 40 mg/ml Powder for solution for infusion", "holder": "InfectoPharm Arzneimittel und Consilium GmbH", "authorised_date": "2015-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01XX", "J01XX01" ], "active_substances": [ "Fosfomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1972/002/001", "product_name": "Ritalin 10mg Tablets", "holder": "InfectoPharm Arzneimittel und Consilium GmbH", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1972/002/002", "product_name": "Ritalin LA 20mg prolonged-release capsules", "holder": "InfectoPharm Arzneimittel und Consilium GmbH", "authorised_date": "2003-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1972/002/003", "product_name": "Ritalin LA 30mg prolonged-release capsules", "holder": "InfectoPharm Arzneimittel und Consilium GmbH", "authorised_date": "2003-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1972/002/004", "product_name": "Ritalin LA 40mg prolonged-release capsules", "holder": "InfectoPharm Arzneimittel und Consilium GmbH", "authorised_date": "2003-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1982/003/001", "product_name": "Daptomycin Xellia 350 mg powder for solution for injection/infusion", "holder": "Xellia Pharmaceuticals ApS", "authorised_date": "2017-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX", "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1982/003/002", "product_name": "Daptomycin Xellia 500 mg powder for solution for injection/infusion", "holder": "Xellia Pharmaceuticals ApS", "authorised_date": "2017-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX", "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/002/001", "product_name": "Colecalciferol Aristo 20,000 IU soft capsules", "holder": "Aristo Pharma GmbH", "authorised_date": "2018-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/003/001", "product_name": "Tibolone Aristo 2.5 mg tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2018-01-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03CX", "G03CX01" ], "active_substances": [ "Tibolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/005/001", "product_name": "Calcipotriol/Betamethasone 50 microgram/g + 0.5 mg/g gel", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-06-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D05AX52" ], "active_substances": [ "Betamethasone", "Calcipotriol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/007/001", "product_name": "Fesoterodine Aristo 4 mg prolonged-release tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/007/002", "product_name": "Fesoterodine Aristo 8 mg prolonged-release tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/008/001", "product_name": "Abiraterone Aristo 250 mg tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/008/002", "product_name": "Abiraterone Aristo 500 mg film-coated tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/010/001", "product_name": "Prucalopride Aristo 1 mg film-coated tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AX05" ], "active_substances": [ "Prucalopride Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/010/002", "product_name": "Prucalopride Aristo 2 mg film-coated tablets", "holder": "Aristo Pharma GmbH", "authorised_date": "2021-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AX05" ], "active_substances": [ "Prucalopride Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/011/001", "product_name": "Apixaban Aristo 1.25 mg/ml oral suspension", "holder": "Aristo Pharma GmbH", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "B01A", "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1983/012/001", "product_name": "Arinaya 1.25 mg/ml 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"market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03A" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/001/006", "product_name": "Pregabalin Teva 200 mg capsules, hard", "holder": "Teva B.V.", "authorised_date": "2015-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03A" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/001/008", "product_name": "Pregabalin Teva 300 mg capsules, hard", "holder": "Teva B.V.", "authorised_date": "2015-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03A" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/002/001", "product_name": "Etoricoxib Teva 30 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/002/002", "product_name": "Etoricoxib Teva 60 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/002/003", "product_name": "Etoricoxib Teva 90 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/002/004", "product_name": "Etoricoxib Teva 120 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/003/001", "product_name": "Tenofovir Disoproxil Teva 245 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2015-08-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AF07" ], "active_substances": [ "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/006/001", "product_name": "Braltus 10 microgram per delivered dose inhalation powder, hard capsule", "holder": "Teva B.V.", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03BB", "R03BB04" ], "active_substances": [ "Tiotropium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/007/001", "product_name": "Cinacalcet Teva 30 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05B" ], "active_substances": [ "TALC PH.EUR.", "Cinacalcet" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/007/002", "product_name": "Cinacalcet Teva 60 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05B" ], "active_substances": [ "Cinacalcet" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/007/003", "product_name": "Cinacalcet Teva 90 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-02-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "H05B" ], "active_substances": [ "Cinacalcet" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/008/001", "product_name": "Lansoprazole Teva Pharma 15 mg gastro-resistant capsules, hard", "holder": "Teva B.V.", "authorised_date": "2015-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/008/002", "product_name": "Lansoprazole Teva Pharma 30 mg gastro-resistant capsules, hard", "holder": "Teva B.V.", "authorised_date": "2015-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/011/001", "product_name": "Fulvestrant Teva 250 mg Solution for Injection in Pre-filled Syringe", "holder": "Teva B.V.", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L02BA", "L02BA03" ], "active_substances": [ "Fulvestrant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/016/001", "product_name": "Emtricitabine/Tenofovir disoproxil Teva 200 mg/245 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-05-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Emtricitabine", "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/017/001", "product_name": "Rasagiline Teva 1 mg tablets", "holder": "Teva B.V.", "authorised_date": "2015-12-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Rasagiline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/019/001", "product_name": "Aripiprazole Teva 5 mg tablets", "holder": "Teva B.V.", "authorised_date": "2015-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/019/002", "product_name": "Aripiprazole Teva 10 mg tablets", "holder": "Teva B.V.", "authorised_date": "2015-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/019/003", "product_name": "Aripiprazole Teva 15 mg tablets", "holder": "Teva B.V.", "authorised_date": "2015-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/019/004", "product_name": "Aripiprazole Teva 30 mg tablets", "holder": "Teva B.V.", "authorised_date": "2015-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/020/001", "product_name": "Sitagliptin Teva 100 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2016-09-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH", "A10BH01" ], "active_substances": [ "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/021/001", "product_name": "Rispeva 0.5 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2015-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/024/001", "product_name": "Rosuvastatin Teva Pharma 5 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2015-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/024/002", "product_name": "Rosuvastatin Teva Pharma 10 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2015-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/024/003", "product_name": "Rosuvastatin Teva Pharma 20 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2015-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/024/004", "product_name": "Rosuvastatin Teva Pharma 40 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2015-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/025/001", "product_name": "Perindopril tosilate/Indapamide Teva 10 mg/2.5 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2017-01-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BA", "C09BA04" ], "active_substances": [ "Perindopril tosilate", "Indapamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/031/001", "product_name": "Sildenafil Teva 20 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/033/001", "product_name": "Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600 mg/200 mg/245 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2017-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR06" ], "active_substances": [ "Efavirenz", "Emtricitabine", "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/045/001", "product_name": "Anidulafungin Teva 100 mg Powder for Concentrate for Solution for Infusion", "holder": "Teva B.V.", "authorised_date": "2018-02-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX", "J02AX06" ], "active_substances": [ "Anidulafungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/046/001", "product_name": "COLOMYCIN 1 million International Units (IU) Powder for solution for injection, infusion or inhalation", "holder": "Teva B.V.", "authorised_date": "2005-06-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for 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"legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/050/001", "product_name": "Flecainide 50mg Tablets", "holder": "Teva B.V.", "authorised_date": "2006-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BC", "C01BC04" ], "active_substances": [ "Flecainide acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/050/002", "product_name": "Flecainide 100mg Tablets", "holder": "Teva B.V.", "authorised_date": "2006-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BC", "C01BC04" ], "active_substances": [ "Flecainide acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/001", "product_name": "Lenalidomide Teva 2.5 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide hydrochloride hydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/002", "product_name": "Lenalidomide Teva 5 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/003", "product_name": "Lenalidomide Teva 7.5 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/004", "product_name": "Lenalidomide Teva 10 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/005", "product_name": "Lenalidomide Teva 15 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/006", "product_name": "Lenalidomide Teva 20 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/051/007", "product_name": "Lenalidomide Teva 25 mg hard capsules", "holder": "Teva B.V.", "authorised_date": "2019-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX", "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/052/001", "product_name": "Quinine Sulphate 300 mg film coated tablets", "holder": "Teva B.V.", "authorised_date": "1985-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "P01BC", "P01BC01" ], "active_substances": [ "Quinine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/053/001", "product_name": "Tetridar 20 micrograms/80 microlitres Solution for Injection in pre-filled pen", "holder": "Teva B.V.", "authorised_date": "2018-06-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H05AA", "H05AA02" ], "active_substances": [ "Teriparatide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/054/001", "product_name": "Hydrocortone 10 mg Tablets", "holder": "Teva B.V.", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/055/001", "product_name": "Nasobec 50 Micrograms Aqueous Nasal Spray", "holder": "Teva B.V.", "authorised_date": "1999-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD01" ], "active_substances": [ "Beclometasone dipropionate" ], "routes": [ "Intranasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/066/001", "product_name": "Dasatinib Teva 20 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2019-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/066/002", "product_name": "Dasatinib Teva 50 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2019-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE06" ], "active_substances": [ "Dasatinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"2016-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/067/003", "product_name": "Ezetimibe/Simvastatin Teva Pharma 10 mg/80 mg tablets", "holder": "Teva B.V.", "authorised_date": "2016-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/068/001", "product_name": "Irinotecan Hydrochloride 20 mg/mL concentrate for solution for infusion", "holder": "Teva B.V.", "authorised_date": "2008-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX19" ], "active_substances": [ "Irinotecan hydrochloride trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/076/001", "product_name": "Olatuton 10 mg powder and solvent for prolonged-release suspension for injection", "holder": "Teva B.V.", "authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/076/002", "product_name": "Olatuton 20 mg powder and solvent for prolonged-release suspension for injection", "holder": "Teva B.V.", "authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/076/003", "product_name": "Olatuton 30 mg powder and solvent for prolonged-release suspension for injection", "holder": "Teva B.V.", "authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "H01CB", "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/078/001", "product_name": "Exorex Lotion 5% v/w Cutaneous Emulsion", "holder": "Teva B.V.", "authorised_date": "2003-10-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous emulsion", "atc_codes": [ "D05AA" ], "active_substances": [ "Coal tar solution" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/080/001", "product_name": "Zorclone 7.5 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/081/001", "product_name": "Doxycycline Teva 100mg Hard Capsules", "holder": "Teva B.V.", "authorised_date": "1985-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA", "J01AA02" ], "active_substances": [ "Doxycycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/082/001", "product_name": "Ipramol Steri-Neb 0.5 mg/2.5 mg per 2.5 ml nebuliser solution", "holder": "Teva B.V.", "authorised_date": "2005-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AL", "R03AL02" ], "active_substances": [ "Ipratropium bromide", 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"Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/085/002", "product_name": "Nortem 20mg Tablets", "holder": "Teva B.V.", "authorised_date": "1993-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05CD", "N05CD07" ], "active_substances": [ "Temazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/086/001", "product_name": "Salamol Steri-Neb 2.5 mg/2.5 ml nebuliser solution", "holder": "Teva B.V.", "authorised_date": "2002-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AC", "R03AC02" ], "active_substances": [ "SALBUTAMOL SULFATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/086/002", "product_name": "Salamol Steri-Neb 5 mg/2.5 ml Nebuliser Solution", "holder": "Teva B.V.", "authorised_date": "2003-01-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AC", "R03AC02" ], "active_substances": [ "Salbutamol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/087/001", "product_name": "Saline Steri-Neb 0.9% w/v Nebuliser 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[ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/098/001", "product_name": "Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/5 mg Tablets", "holder": "Teva B.V.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril tosilate", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/098/002", "product_name": "Perindopril Tosilate/Amlodipine Teva B.V. 5 mg/10 mg Tablets", "holder": "Teva B.V.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril tosilate", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/098/003", "product_name": "Perindopril Tosilate/Amlodipine Teva B.V. 10 mg/5 mg Tablets", "holder": "Teva B.V.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril tosilate", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/098/004", "product_name": "Perindopril Tosilate/Amlodipine Teva B.V. 10 mg/10 mg Tablets", "holder": "Teva B.V.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BB04" ], "active_substances": [ "Perindopril tosilate", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/099/001", "product_name": "Venlatev 37.5 mg hard prolonged-release capsules", "holder": "Teva B.V.", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/099/002", "product_name": "Venlatev 75 mg hard prolonged-release capsules", "holder": "Teva B.V.", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/099/003", "product_name": "Venlatev 150 mg hard prolonged-release capsules", "holder": "Teva B.V.", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/101/001", "product_name": "Paracetamol Teva 500 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2022-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/102/001", "product_name": "Sugammadex Teva 100 mg/ml solution for injection", "holder": "Teva B.V.", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/103/001", "product_name": "Abiraterone Teva 500 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2022-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/105/001", "product_name": "Dexamethasone phosphate Teva 4 mg/ml solution for injection", "holder": "Teva B.V.", "authorised_date": "2022-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Infiltration", "Intraarticular use", "Intramuscular use", "Intravenous use", "Subconjunctival use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"2024-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/108/003", "product_name": "Perindopril arginine/Indapamide/Amlodipine Teva 10 mg/2.5 mg/5 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to 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"holder": "Teva B.V.", "authorised_date": "2023-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD58" ], "active_substances": [ "Azelastine hydrochloride", "Fluticasone propionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/110/001", "product_name": "Antabuse 400 mg Effervescent Tablets", "holder": "Teva B.V.", "authorised_date": "1985-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N07BB", "N07BB01" ], "active_substances": [ "Disulfiram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/111/001", "product_name": "Floxapen 250mg Powder for solution for Injection or Infusion", "holder": "Teva B.V.", "authorised_date": "1979-01-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intraarticular use", "Intramuscular use", "Intrapleural use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/111/002", "product_name": "Floxapen 500 mg Powder for Solution for Injection or Infusion", "holder": "Teva B.V.", "authorised_date": "1979-01-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intraarticular use", "Intramuscular use", "Intrapleural use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/111/003", "product_name": "Floxapen 1000 mg powder for solution for injection or infusion", "holder": "Teva B.V.", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/111/004", "product_name": "Floxapen 2000 mg powder for solution for injection or infusion", "holder": "Teva B.V.", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/113/001", "product_name": "Neotigason 10 mg capsules", "holder": "Teva B.V.", "authorised_date": "1992-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "D05BB", "D05BB02" ], "active_substances": [ "Acitretin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/113/002", "product_name": "Neotigason 25 mg capsules", "holder": "Teva B.V.", "authorised_date": "1992-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "D05BB", "D05BB02" ], "active_substances": [ "Acitretin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/114/001", "product_name": "Cetriz 10mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2006-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/115/001", "product_name": "Exemestane Teva 25 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG06" ], "active_substances": [ "Exemestane" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/116/001", "product_name": "Buplex 200mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2009-07-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/116/002", "product_name": "Buplex 400mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2009-07-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/117/001", "product_name": "Buplex Rx 200 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2009-07-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/117/002", "product_name": "Buplex Rx 400 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2009-07-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/117/003", "product_name": "Buplex Rx 600 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2009-07-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be 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"PA1986/120/002", "product_name": "Sastravi 75mg/18.75mg/200mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2014-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/120/003", "product_name": "Sastravi 100mg/25mg/200mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2014-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/120/004", "product_name": "Sastravi 125mg/31.25mg/200mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2014-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/120/005", "product_name": "Sastravi 150mg/37.5mg/200mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2014-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/120/006", "product_name": "Sastravi 175mg/43.75mg/200mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2014-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N04BA", "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa", "Entacapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA09" ], "active_substances": [ "Bendamustine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/121/002", "product_name": "Bendamustine 100 mg Powder for Concentrate for Solution for Infusion", "holder": "Teva B.V.", "authorised_date": "2015-05-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA09" ], "active_substances": [ "Bendamustine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/122/001", "product_name": "Gemcitabine Teva 40 mg/ml Concentrate for Solution for Infusion", "holder": "Teva B.V.", "authorised_date": "2016-03-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/123/001", "product_name": "Ticagrelor Teva 90 mg Film-coated Tablets", "holder": "Teva B.V.", "authorised_date": "2024-01-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/124/001", "product_name": "Ferric carboxymaltose Teva 50 mg iron/ml dispersion for injection/infusion", "holder": "Teva B.V.", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersion for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "Ferric carboxymaltose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/125/001", "product_name": "Atorvastatin Teva Pharma 10 mg Film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2024-11-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/125/002", "product_name": "Atorvastatin Teva Pharma 20 mg Film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2024-11-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/126/001", "product_name": "Fluticasone Furoate Teva 27.5 micrograms/spray, nasal spray, suspension", "holder": "Teva B.V.", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD12" ], "active_substances": [ "Fluticasone furoate" ], "routes": [ "Intranasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) 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"dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA03" ], "active_substances": [ "Varenicline Citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/129/002", "product_name": "Varenicline Teva 1 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA03" ], "active_substances": [ "Varenicline Citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/129/003", "product_name": "Varenicline Teva 0.5 mg film-coated tablets Varenicline Teva 1 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA03" ], "active_substances": [ "Varenicline Citrate", "Varenicline Citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/130/001", "product_name": "Paracetamol 500 mg tablets", "holder": "Teva B.V.", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AF01" ], "active_substances": [ "Tofacitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1986/132/002", "product_name": "Tofacitinib Teva 10 mg film-coated tablets", "holder": "Teva B.V.", "authorised_date": "2026-10-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AF01" ], "active_substances": [ "Tofacitinib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1989/001/001", "product_name": "Caspofungin 50mg powder for concentrate for solution for infusion", "holder": "Demo S.A.", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX", "J02AX04" ], "active_substances": [ "Caspofungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1989/001/002", "product_name": "Caspofungin 70mg powder for concentrate for solution for infusion", "holder": "Demo S.A.", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX", "J02AX04" ], "active_substances": [ "Caspofungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1989/002/001", "product_name": "Esomeprazole 40 mg powder for solution for injection/infusion", "holder": "Demo S.A.", "authorised_date": "2025-07-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA1996/001/001", "product_name": "Celsior solution for organ preservation", "holder": "Institut Georges Lopez - IGL", "authorised_date": "2011-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for organ preservation", "atc_codes": [ "V07AB" ], "active_substances": [ "Glutathione", "Mannitol", "Lactobionic acid", "Glutamic acid", "Sodium hydroxide", "Calcium chloride 2 h2o", "Potassium chloride", "Magnesium chloride 6 h2o", "Histidine" ], "routes": [ "Extracorporeal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/001/002", "product_name": "FEIBA 50 U/ml powder and solvent for solution for infusion", "holder": "Baxalta Innovations GmbH", "authorised_date": "2010-05-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02BD", "B02BD03" ], "active_substances": [ "Feiba" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/001/003", "product_name": "FEIBA 100 U/ml powder and solvent for solution for infusion", "holder": "Baxalta Innovations GmbH", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02BD03" ], "active_substances": [ "Factor VIII inhibitor bypassing fraction" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/002/001", "product_name": "Flexbumin 200 g/l solution for infusion", "holder": "Baxalta Innovations GmbH", "authorised_date": "2007-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Human plasma protein" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/004/001", "product_name": "Human Albumin Baxalta 50 g/l Solution for Infusion", "holder": "Baxalta Innovations GmbH", "authorised_date": "2006-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Plasma protein containing at least 95% human albumin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/004/002", "product_name": "Human Albumin Baxalta 200 g/l Solution for Infusion", "holder": "Baxalta Innovations GmbH", "authorised_date": "2006-12-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Plasma protein containing at least 95% human albumin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/005/002", "product_name": "Prothromplex TOTAL 500 IU powder and solvent for solution for infusion", "holder": "Baxalta Innovations GmbH", "authorised_date": "2023-06-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for concentrate for solution for infusion", "atc_codes": [ "B02BD01" ], "active_substances": [ "Human coagulation factor ii", "Human coagulation factor vii", "Human coagulation factor ix", "Human coagulation factor x", "Human Protein C" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2004/008/001", "product_name": "Cuvitru 200 mg/ml solution for subcutaneous injection", "holder": "Baxalta Innovations GmbH", "authorised_date": "2016-07-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for...", "atc_codes": [ "J06BA01" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2018/001/001", "product_name": "Asacolon 400mg Gastro-Resistant Tablets", "holder": "Tillotts Pharma GmbH", "authorised_date": "1990-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2018/001/002", "product_name": "Asacolon 800mg Gastro-resistant Tablets", "holder": "Tillotts Pharma GmbH", "authorised_date": "2003-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2018/001/003", "product_name": "Asacolon 500 mg Suppositories", "holder": "Tillotts Pharma GmbH", "authorised_date": "1995-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2018/003/001", "product_name": "Entocort CR 3 mg Gastro-resistant Capsule, Hard", "holder": "Tillotts Pharma GmbH", "authorised_date": "1996-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A07EA", "A07EA06" ], "active_substances": [ "Budesonide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2018/004/001", "product_name": "Asacolon 1600 mg modified-release tablets", "holder": "Tillotts Pharma GmbH", "authorised_date": "2018-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2018/005/001", "product_name": "Asacolon 1000 mg Suppository", "holder": "Tillotts Pharma GmbH", "authorised_date": "2021-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2021/001/001", "product_name": "Accusol 35 Solution for haemofiltration, haemodialysis and haemodiafiltration", "holder": "Nikkiso Belgium bvba", "authorised_date": "2006-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Calcium chloride", "Magnesium chloride", "Sodium bicarbonate" ], "routes": [ "Haemodialysis", "Intraarterial use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2021/002/001", "product_name": "Accusol 35 Potassium 2 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration", "holder": "Nikkiso Belgium bvba", "authorised_date": "2006-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Calcium chloride", "Magnesium chloride", "Sodium bicarbonate", "Potassium chloride", "Glucose anhydrous" ], "routes": [ "Haemodialysis", "Intraarterial use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2021/002/002", "product_name": "Accusol 35 Potassium 4 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration", "holder": "Nikkiso Belgium bvba", "authorised_date": "2006-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Calcium chloride", "Magnesium chloride", "Sodium bicarbonate", "Potassium chloride", "Glucose anhydrous" ], "routes": [ "Haemodialysis", "Intraarterial use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2028/001/001", "product_name": "Cleenema Ready-to-Use 21.4 g/9.4 g Enema", "holder": "Casen-Recordati S.L.", "authorised_date": "1995-02-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal solution", "atc_codes": [ "A06AG", "A06AG01" ], "active_substances": [ "Sodium dihydrogen phosphate dihydrate", "Disodium phosphate dodecahydrate" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2028/002/001", "product_name": "CitraFleet, Powder for oral solution in sachet", "holder": "Casen-Recordati S.L.", "authorised_date": "2008-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution in sachet", "atc_codes": [ "A06AB", "A06AB58" ], "active_substances": [ "Sodium picosulfate", "Light magnesium oxide", "Citric acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2028/002/002", "product_name": "CitraFleet oral solution", "holder": "Casen-Recordati S.L.", "authorised_date": "2023-03-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AB58" ], "active_substances": [ "Sodium picosulfate", "Magnesium oxide, light", "Citric acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2028/003/001", "product_name": "Peglax 10 g powder for oral solution in sachet", "holder": "Casen-Recordati S.L.", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD15" ], "active_substances": [ "Macrogol 4000" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2028/004/001", "product_name": "Phospho-soda 24.4 g/10.8 g Oral solution", "holder": "Casen-Recordati S.L.", "authorised_date": "1998-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD" ], "active_substances": [ "Sodium phosphate dibasic dihydrate", "Disodium phosphas dodecahydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2030/001/001", "product_name": "Famciclovir 500 mg 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"HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/003", "product_name": "Warfarin Teva 2 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/004", "product_name": "Warfarin Teva 2.5 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/005", "product_name": "Warfarin Teva 3 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/006", "product_name": "Warfarin Teva 5 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/007", "product_name": "Warfarin Teva 6 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/008", "product_name": "Warfarin Teva 7.5 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/001/009", "product_name": "Warfarin Teva 10 mg tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2007-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B01AA", "B01AA03" ], "active_substances": [ "Warfarin sodium clathrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/002/001", "product_name": "Clarithromycin 250 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2006-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/002/002", "product_name": "Clarithromycin 500 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2006-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/003/001", "product_name": "Atorvastatin 10mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/003/002", "product_name": "Atorvastatin 20 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/003/003", "product_name": "Atorvastatin 40 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/003/004", "product_name": "Atorvastatin 80 mg film-coated tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/005/001", "product_name": "Ceziboe 0.25 mg solution for injection in pre-filled syringe", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CC02" ], "active_substances": [ "Cetrorelix" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/006/001", "product_name": "Estradiol SUN 10 micrograms vaginal tablets", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-08-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal tablet", "atc_codes": [ "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/007/001", "product_name": "Isotretinoin SUN 10 mg soft capsules", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/007/002", "product_name": "Isotretinoin SUN 20 mg soft capsules", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/009/001", "product_name": "Lanreotide SUN 60 mg solution for injection in a pre-filled syringe", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/009/002", "product_name": "Lanreotide SUN 90 mg solution for injection in a pre-filled syringe", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2050/009/003", "product_name": "Lanreotide SUN 120 mg solution for injection in a pre-filled syringe", "holder": "Sun Pharmaceutical Industries Europe B.V.", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/001/001", "product_name": "Folinic acid (as calcium folinate) 10 mg/ml solution for injection or infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2016-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AF", "V03AF03" ], "active_substances": [ "Folinic acid" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/003/001", "product_name": "Lidocaine Hydrochloride 1% w/v Solution for Injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2018-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/003/002", "product_name": "Lidocaine Hydrochloride 2% w/v Solution for Injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2018-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Epidural use", "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/004/001", "product_name": "Adenosine 3 mg/ml solution for injection in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01EB", "C01EB10" ], "active_substances": [ "Adenosine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/006/001", "product_name": "Cefuroxime 750 mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-08-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime Sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/006/002", "product_name": "Cefuroxime 1.5 g powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-08-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for 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Directive No 2001/83/EC)" }, { "licence_number": "PA2059/008/001", "product_name": "Geloplasma, Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2007-04-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA" ], "active_substances": [ "Modified liquid gelatine", "Sodium chloride", "Magnesium chloride hexahydrate", "Potassium chloride", "Sodium lactate solution" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/008/002", "product_name": "Geloplasma Solution for Infusion (Polyolefine/Freeflex Bag)", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA" ], "active_substances": [ "Modified liquid gelatine", "Sodium chloride", "Magnesium chloride hexahydrate", "Potassium chloride", "Sodium (s)-lactate solution" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/009/001", "product_name": "Levobupivacaine 0.625 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Levobupivacaine" ], "routes": [ "Epidural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/009/002", "product_name": "Levobupivacaine 1.25 mg/mL solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Levobupivacaine" ], "routes": [ "Epidural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/009/003", "product_name": "Levobupivacaine 2.5 mg/mL solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Levobupivacaine" ], "routes": [ "Epidural use", "Infiltration", "Intrathecal use", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/009/004", "product_name": "Levobupivacaine 5.0 mg/mL solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Levobupivacaine" ], "routes": [ "Epidural use", "Infiltration", "Intrathecal use", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/009/005", "product_name": "Levobupivacaine 7.5 mg/mL solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-10-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Levobupivacaine" ], "routes": [ "Epidural use", "Infiltration", "Intrathecal use", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/010/001", "product_name": "Levofloxacin 5 mg/ml solution for infusion, LDPE bottles", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA12" ], "active_substances": [ "Levofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/010/002", "product_name": "Levofloxacin 5 mg/ml solution for infusion, freeflex bags", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2011-02-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA12" ], "active_substances": [ "Levofloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/011/001", "product_name": "Linezolid 2 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01XX", "J01XX08" ], "active_substances": [ "Linezolid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/012/001", "product_name": "Meropenem 500 mg powder for solution for injection or infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/012/002", "product_name": "Meropenem 1 g powder for solution for injection or infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/013/001", "product_name": "Moxifloxacin 400 mg/250 ml Solution for Infusion, KabiPac bottles", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-01-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA14" ], "active_substances": [ "Moxifloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/013/002", "product_name": "Moxifloxacin 400 mg/250 ml Solution for Infusion, FreeFlex bags", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-01-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01MA", "J01MA14" ], "active_substances": [ "Moxifloxacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/014/001", "product_name": "Palonosetron 250 micrograms Solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2016-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA05" ], "active_substances": [ "Palonosetron hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/014/002", "product_name": "Palonosetron 250 micrograms solution for injection in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2016-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "A04AA", "A04AA05" ], "active_substances": [ "Palonosetron hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/015/001", "product_name": "Paracetamol 10 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/015/002", "product_name": "Paracetamol 10 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/016/001", "product_name": "Piperacillin/Tazobactam 2 g/0.25 g powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2008-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/016/002", "product_name": "Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2008-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/017/001", "product_name": "Propofol 1% (10 mg/ml) emulsion for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2005-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/017/003", "product_name": "Propofol 2% (20 mg/ml) emulsion for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2005-04-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/017/004", "product_name": "Propofol 1% (10 mg/ml) emulsion for injection/infusion in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2013-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion in pre-filled syringe", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/017/005", "product_name": "Propofol 2% (20 mg/ml) emulsion for injection/infusion in pre-filled syringe", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2013-04-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion in pre-filled syringe", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/018/001", "product_name": "Rocuronium 10 mg/ml solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2008-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/019/001", "product_name": "Zoledronic acid 4 mg/5 ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2012-10-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "M05BA", "M05BA08" ], "active_substances": [ "Zoledronic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/020/001", "product_name": "Voriconazole 200mg powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-10-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AC", "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/021/001", "product_name": "Ropivacaine 2 mg/ml solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB09" ], "active_substances": [ "Ropivacaine Hydrochloride" ], "routes": [ "Epidural use", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/021/002", "product_name": "Ropivacaine 7.5 mg/ml solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB09" ], "active_substances": [ "Ropivacaine Hydrochloride" ], "routes": [ "Epidural use", "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/022/001", "product_name": "SmofKabiven Low Osmo Peripheral emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Alanine", "Arginine", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine", "Methionine", "Phenylalanine", "Proline", "Serine", "Taurine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Calcium chloride", "Sodium glycerophosphate", "Magnesium sulphate", "Potassium chloride", "Sodium acetate", "Zinc sulphate", "Glucose", "Soya bean oil, refined", "Triglycerides, medium chain", "Olive oil, refined", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/023/002", "product_name": "Additrace N concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA31" ], "active_substances": [ "Chromic chloride hexahydrate", "Copper chloride dihydrate", "Ferric chloride hexahydrate", "Manganese chloride tetrahydrate", "Potassium iodide", "Sodium fluoride", "Sodium molybdate dihydrate", "Sodium selenite anhydrous", "Zinc chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/024/001", "product_name": "Addiphos concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA30" ], "active_substances": [ "Potassium dihydrogen phosphate", "Potassium hydroxide", "Disodium phosphate dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/025/001", "product_name": "Aminoven 8 solution for infusion, bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1999-09-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine acetate", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine", "Alanine", "Glycine", "Proline", "Serine", "Tyrosine", "Taurine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/025/002", "product_name": "Aminoven 16 solution for infusion, bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1999-09-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine acetate", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine", "Alanine", "Glycine", "Proline", "Serine", "Tyrosine", "Taurine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/025/003", "product_name": "Aminoven 25 solution for infusion, bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1999-09-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Isoleucine", "Leucine", "Lysine acetate", "Methionine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine", "Alanine", "Glycine", "Proline", "Serine", "Tyrosine", "Taurine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/026/001", "product_name": "Co-amoxiclav 1000mg/200mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/028/001", "product_name": "Bendamustine HCl 25 mg Powder for Concentrate for Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2016-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA09" ], "active_substances": [ "Bendamustine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/028/002", "product_name": "Bendamustine HCl 100 mg Powder for Concentrate for Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2016-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA09" ], "active_substances": [ "Bendamustine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/029/001", "product_name": "Paedisol Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2016-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Sodium acetate trihydrate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/032/001", "product_name": "Carboplatin 10 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2012-02-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XA", "L01XA02" ], "active_substances": [ "Carboplatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/034/001", "product_name": "Cytarabine 100 mg/ml Solution for Injection or Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2012-11-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01BC", "L01BC01" ], "active_substances": [ "Cytarabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/035/001", "product_name": "Water for injections, solvent for parenteral use", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-08-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for parenteral use", "atc_codes": [ "V07AB" ], "active_substances": [ "Water for injections" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/036/001", "product_name": "Etoposide 20 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CB", "L01CB01" ], "active_substances": [ "Etoposide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/038/001", "product_name": "Furosemide 20 mg/2 ml solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2008-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/039/001", "product_name": "Gemcitabine 200 mg powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/039/002", "product_name": "Gemcitabine 1 g powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/039/003", "product_name": "Gemcitabine 2 g powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/039/005", "product_name": "Gemcitabine 38 mg/ml Concentrate for Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-01-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/040/001", "product_name": "Glucose 5% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/002", "product_name": "Glucose 5% w/v, Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/003", "product_name": "Glucose 5% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/004", "product_name": "Glucose 5% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/005", "product_name": "Glucose 10% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/006", "product_name": "Glucose 10% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/007", "product_name": "Glucose 10% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/008", "product_name": "Glucose 10% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/009", "product_name": "Glucose 5% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/040/010", "product_name": "Glucose 10% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2059/041/001", "product_name": "Intralipid 20% w/v Emulsion for Infusion, Glass Bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1989-04-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA02" ], "active_substances": [ "Soya bean oil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/041/005", "product_name": "Intralipid 20% w/v Emulsion for Infusion Biofine bag", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2012-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA02" ], "active_substances": [ "Soya bean oil, refined" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/042/001", "product_name": "Ionolyte solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-10-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium acetate trihydrate", "Sodium chloride", "Potassium chloride", "Magnesium chloride hexahydrate", "Sodium hydroxide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/044/001", "product_name": "Irinotecan 20 mg/ml Concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2008-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX09" ], "active_substances": [ "Irinotecan hydrochloride trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/045/003", "product_name": "Kabiven emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2006-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Soya bean oil", "Glucose monohydrate", "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Calcium chloride 2 h2o", "Sodium glycerophosphate anhydrous", "Magnesium sulphate 7h2o", "Potassium chloride", "Sodium acetate 3 H20" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/045/004", "product_name": "Kabiven Peripheral emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2006-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Soya bean oil", "Alanine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Methionine", "Phenylalanine", "Proline", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium glycerophosphate anhydrous", "Potassium chloride", "Glucose monohydrate", "Arginine", "Lysine hydrochloride", "Serine", "Calcium chloride 2 h2o", "Magnesium sulphate 7h2o", "Sodium acetate 3 H20" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/048/001", "product_name": "Ondansetron Kabi 2 mg/ml solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2007-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/049/001", "product_name": "Oxaliplatin 5 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XA", "L01XA03" ], "active_substances": [ "Oxaliplatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/050/001", "product_name": "Paclitaxel 6 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CD", "L01CD01" ], "active_substances": [ "Paclitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/051/001", "product_name": "Peditrace concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1995-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA31" ], "active_substances": [ "Zinc chloride", "Copper chloride 2H2O", "Manganese chloride 4H2O", "Sodium selenite anhydrous", "Sodium fluoride", "Potassium iodide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/052/001", "product_name": "Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Potassium chloride", "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/052/002", "product_name": "Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Potassium chloride", "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/053/001", "product_name": "Potassium Chloride 0.15% w/v & Glucose 5% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-09-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Potassium chloride", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/053/002", "product_name": "Potassium Chloride 0.3% w/v & Glucose 5% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2015-09-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Potassium chloride", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/054/001", "product_name": "Potassium Chloride 15% w/v Concentrate for Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-07-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA", "B05XA01" ], "active_substances": [ "Potassium chloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/055/001", "product_name": "Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or infusion, ampoule", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1998-05-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/055/002", "product_name": "Propofol 1 % (10 mg/1 ml) Fresenius emulsion for injection or infusion, vial", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1998-05-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/055/003", "product_name": "Propofol 2 % (20 mg/1 ml) Fresenius emulsion for injection or infusion, ampoule", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2001-11-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/055/004", "product_name": "Propofol 2 % (20 mg/1 ml) Fresenius emulsion for injection or infusion, vial", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2001-11-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/056/001", "product_name": "Remifentanil 1 mg powder for concentrate for solution for injection or infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/056/002", "product_name": "Remifentanil 2 mg powder for concentrate for solution for injection or infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/056/003", "product_name": "Remifentanil 5 mg powder for concentrate for solution for injection or infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH06" ], "active_substances": [ "Remifentanil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/057/001", "product_name": "Hartmann’s Solution for Infusion, PVC bag", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2005-05-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate", "Sodium lactate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/057/002", "product_name": "Hartmann’s Solution for Infusion, PSEB bag", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2005-05-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate", "Sodium lactate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/057/003", "product_name": "Hartmann’s Solution for Infusion, PPC PSEB bag", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2005-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate", "Sodium lactate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/057/004", "product_name": "Hartmann’s Solution for Infusion, glass bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2005-05-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calciumchloride dihydrate", "Sodium lactate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/057/005", "product_name": "Hartmann's Solution for Infusion, PE bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate", "Sodium lactate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/058/002", "product_name": "SmofKabiven Central emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Soya bean oil, refined", "Medium chain triglycerides", "Refined soyabean oil", "Fish oil, rich in omega-3 acids", "L-alanine", "L-arginine", "Glycine (aminoacetic acid)", "L-histidine", "L-isoleucine", "L-leucine", "L-lysine", "L-methionine", "L-phenylalanine", "L-proline", "L-serine", "Taurine", "L-threonine", "L-tryptophan", "L-tyrosine", "L-valine", "Calcium chloride", "Sodium glycerophosphate", "Magnesium sulfate", "Potassium chloride", "Sodium acetate", "Zinc sulfate", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/059/002", "product_name": "SmofKabiven Electrolyte Free Central emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "L-alanine", "L-arginine", "Glycine", "L-histidine", "L-isoleucine", "L-leucine", "L-lysine acetate", "L-methionine", "L-phenylalanine", "L-proline", "L-serine", "Taurine", "L-threonine", "L-tryptophan", "L-tyrosine", "L-valine", "Glucose monohydrate", "Soya bean oil, refined", "Triglycerides, medium chain", "Olive oil, refined", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/060/001", "product_name": "SmofKabiven extra Nitrogen, emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2017-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Methionine", "Phenylalanine", "Proline", "Serine", "Taurine", "Tryptophan", "Tyrosine", "Valine", "Alanine", "Arginine", "Glycine", "Histidine", "Isoleucine", "Leucine", "Potassium chloride", "Soya bean oil, refined", "Triglycerides, medium chain", "Olive oil, refined", "Fish oil, rich in omega-3 acids", "Lysine", "Calcium chloride", "Sodium glycerophosphate", "Magnesium 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"Lysine", "Threonine", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/061/002", "product_name": "SmofKabiven Peripheral, emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-09-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "SOYA BEAN OIL, REFINED PH. EUR.", "Medium chain triglycerides", "Refined olive oil", "Fish oil, rich in omega-3 acids", "Isoleucine", "Leucine", "Methionine", "Lysine", "Phenylalanine", "Threonine", "Tryptophan", "Valine", "Arginine", "Histidine", "Alanine", "Glycine", "Proline", "Serine", "Tyrosine", "Taurine", "Calcium chloride", "Sodium glycerophosphate", "Magnesium sulphate", "Potassium chloride", "Sodium acetate", "Zinc sulphate heptahydrate", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/062/001", "product_name": "SMOFlipid 200 mg/ml emulsion for infusion, glass bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2004-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA02" ], "active_substances": [ "Soybean oil", "Triglycerides, medium chain", "Refined olive oil", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/062/002", "product_name": "SMOFlipid 200 mg/ml emulsion for infusion, excel bag", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2007-08-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA02" ], "active_substances": [ "Soya bean oil", "Medium chain triglycerides", "Refined olive oil", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/063/001", "product_name": "Sodium Chloride 0.9% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/063/002", "product_name": "Sodium Chloride 0.9% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/063/003", "product_name": "Sodium Chloride 0.9% w/v solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/063/004", "product_name": "Sodium Chloride 0.9% w/v Solution for Infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2003-08-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/063/005", "product_name": "Sodium Chloride 0.9% w/v Solution for Infusion, polyethylene bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/063/006", "product_name": "Sodium chloride 0.9% w/v solvent for parenteral use", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for parenteral use", "atc_codes": [ "B05XA", "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/064/001", "product_name": "Solivito N powder for concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1999-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "B05XC" ], "active_substances": [ "Thiamine nitrate", "Riboflavin sodium phosphate", "Nicotinamide", "Pyridoxine hydrochloride", "Sodium pantothenate", "Sodium ascorbate", "Biotin", "Folic acid", "Cyanocobalamin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/065/001", "product_name": "Vaminolact solution for infusion, 100 ml bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1991-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Cysteine", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Taurine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/065/002", "product_name": "Vaminolact solution for infusion, 500 ml bottle", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1991-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Cysteine", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Taurine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/066/001", "product_name": "Vancomycin 500 mg powder for concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2011-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for 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application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/067/001", "product_name": "Vitlipid N Adult concentrate for emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1988-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for emulsion for infusion", "atc_codes": [ "B05XC" ], "active_substances": [ "Ergocalciferol", "Phytomenadione", "Dl-alpha-tocopherol", "Retinol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/067/002", "product_name": "Vitlipid N Infant concentrate for emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "1988-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for emulsion for infusion", "atc_codes": [ "B05XC" ], "active_substances": [ "Ergocalciferol", "Phytomenadione", "Dl-alpha-tocopherol", "Retinol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/069/001", "product_name": "Flucloxacillin 500 mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Intraarticular use", "Intramuscular use", "Intrapleural use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/069/002", "product_name": "Flucloxacillin 1000 mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Intraarticular use", "Intramuscular use", "Intrapleural use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/069/003", "product_name": "Flucloxacillin 2000 mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Intraarticular use", "Intramuscular use", "Intrapleural use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/072/001", "product_name": "Amikacin 5 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J01GB", "J01GB06" ], "active_substances": [ "Amikacin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/073/001", "product_name": "Noradrenaline (Norepinephrine) Kabi 1 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2021-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA03" ], "active_substances": [ "Sodium chloride", "Noradrenaline tartrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/074/001", "product_name": "Imipenem/Cilastatin 250 mg/250 mg powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01DH51" ], "active_substances": [ "Imipenem", "Cilastatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/074/002", "product_name": "Imipenem/Cilastatin 500 mg/500 mg powder for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2020-12-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01DH51" ], "active_substances": [ "Imipenem", "Cilastatin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/077/001", "product_name": "Dexamethasone phosphate 4 mg/ml solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2022-07-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Infiltration", "Intraarticular use", "Intrabursal use", "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/078/001", "product_name": "Lacosamide Fresenius Kabi 10 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2022-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/079/001", "product_name": "Thiotepa Fresenius Kabi 15 mg powder for concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-05-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AC01" ], "active_substances": [ "Thiotepa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/079/002", "product_name": "Thiotepa Fresenius Kabi 100 mg powder for concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-05-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AC01" ], "active_substances": [ "Thiotepa" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/080/001", "product_name": "Ondansetron Kabi 0.08 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2022-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "A04AA01" ], "active_substances": [ "Ondansetron hydrochloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/080/002", "product_name": "Ondansetron Kabi 0.16 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2022-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "A04AA01" ], "active_substances": [ "Ondansetron hydrochloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/082/001", "product_name": "Cabazitaxel Fresenius Kabi 20 mg/ml concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-01-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CD04" ], "active_substances": [ "Cabazitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/083/001", "product_name": "Infutraze concentrate for solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "B05XA31" ], "active_substances": [ "Copper chloride dihydrate", "Manganese chloride tetrahydrate", "Potassium iodide", "Sodium selenite anhydrous", "Zinc chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/085/001", "product_name": "Benzylpenicillin sodium 600 mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/085/002", "product_name": "Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CE01" ], "active_substances": [ "Benzylpenicillin Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/086/001", "product_name": "Ephedrine Kabi 3 mg/mL solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/086/002", "product_name": "Ephedrine Kabi 10 mg/mL solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/086/003", "product_name": "Ephedrine Kabi 30 mg/mL solution for injection", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C01CA26" ], "active_substances": [ "Ephedrine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/087/001", "product_name": "Pedismof Neonate emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA10" ], "active_substances": [ "L-alanine", "L-arginine", "L-aspartic acid", "L-cysteine", "L-glutamine acid", "Glycine", "L-histidine", "L-isoleucine", "L-leucine", "L-lysine", "L-methionine", "L-phenylalanine", "L-proline", "L-serine", "Taurine", "L-threonine", "L-tryptophan", "L-tyrosine", "L-valine", "Glucose monohydrate", "Soya-bean oil refined", "Triglycerides, medium chain", "Olive oil, refined", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/087/002", "product_name": "Pedismof Neonate and Infant emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA10" ], "active_substances": [ "L-alanine", "L-arginine", "L-aspartic acid", "L-cysteine", "L-glutamine acid", "Glycine", "L-histidine", "L-isoleucine", "L-leucine", "L-lysine", "L-methionine", "L-phenylalanine", "L-proline", "L-serine", "Taurine", "L-threonine", "L-tryptophan", "L-tyrosine", "L-valine", "Calcium gluconate", "Sodium glycerophosphate", "Magnesium sulfate", "Potassium chloride", "Glucose monohydrate", "Soya-bean oil refined", "Triglycerides, medium chain", "Olive oil, refined", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/087/003", "product_name": "Pedismof emulsion for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA10" ], "active_substances": [ "L-alanine", "L-arginine", "L-aspartic acid", "L-cysteine", "L-glutamine acid", "Glycine", "L-histidine", "L-isoleucine", "L-leucine", "L-lysine", "L-methionine", "L-phenylalanine", "L-proline", "L-serine", "Taurine", "L-threonine", "L-tryptophan", "L-tyrosine", "L-valine", "Calcium gluconate", "Sodium glycerophosphate", "Magnesium sulfate", "Potassium chloride", "Sodium acetate", "Glucose monohydrate", "Soya-bean oil refined", "Triglycerides, medium chain", "Olive oil, refined", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/088/001", "product_name": "Levetiracetam Kabi 5 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2026-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/088/002", "product_name": "Levetiracetam Kabi 10 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2026-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2059/089/001", "product_name": "Paracetamol Fresenius Kabi 10 mg/ml solution for infusion", "holder": "Fresenius Kabi Deutschland GmbH", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA20595/001/001", "product_name": "Fomepizole SERB 5 mg/mL, concentrate for solution for infusion.", "holder": "SERB S.A.", "authorised_date": "2002-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "V03AB", "V03AB34" ], "active_substances": [ "Fomepizole sulphate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA20595/002/001", "product_name": "Epistatus 10 mg oromucosal solution", "holder": "SERB S.A.", "authorised_date": "2020-08-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA20595/002/002", "product_name": "Epistatus 2.5 mg oromucosal solution", "holder": "SERB S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA20595/002/003", "product_name": "Epistatus 5 mg oromucosal solution", "holder": "SERB S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA20595/002/004", "product_name": "Epistatus 7.5 mg oromucosal solution", "holder": "SERB S.A.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2071/001/001", "product_name": "Alacare 8 mg medicated plaster", "holder": "Photonamic GmbH & Co. KG", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "L01XD", "L01XD04" ], "active_substances": [ "5-aminolevulinic acid hydrochloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2090/002/001", "product_name": "Ibuprofen Farmalider 200 mg film-coated tablets", "holder": "Farmalider S.A.", "authorised_date": "2018-01-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen ph. eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2090/004/001", "product_name": "Diclofenac Liderlens 40 mg/ml cutaneous spray solution", "holder": "Farmalider S.A.", "authorised_date": "2022-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous spray, solution", "atc_codes": [ "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2102/001/001", "product_name": "Blissel 50 micrograms/g vaginal gel", "holder": "Italfarmaco S.A.", "authorised_date": "2016-09-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal gel", "atc_codes": [ "G03CA", "G03CA04" ], "active_substances": [ "Estriol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2102/002/001", "product_name": "Cadelius 600 mg/1000 IU ordispersible tablet", "holder": "Italfarmaco S.A.", "authorised_date": "2017-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium carbonate", "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2102/002/002", "product_name": "Cadelius 600 mg/2000 IU orodispersible tablets", "holder": "Italfarmaco S.A.", "authorised_date": "2020-08-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium carbonate", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2113/001/001", "product_name": "Oralair 100IR & 300IR sublingual tablets", "holder": "Stallergenes", "authorised_date": "2010-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "V01AA", "V01AA02" ], "active_substances": [ "Grass pollen allergen extract" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2113/001/002", "product_name": "Oralair 300 IR sublingual tablets", "holder": "Stallergenes", "authorised_date": "2010-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "V01AA", "V01AA02" ], "active_substances": [ "Grass pollen allergen extract" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" }, { "licence_number": "PA2113/002/001", "product_name": "ACTAIR 100 IR sublingual tablets", "holder": "Stallergenes", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "V01AA03" ], "active_substances": [ "Dermatophagoides Pteronyssinus Extract", "Dermatophagoides Farinae Extract" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)" }, { "licence_number": "PA2113/002/002", "product_name": "ACTAIR 100 IR & 300 IR sublingual tablets", "holder": "Stallergenes", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "V01AA03" ], "active_substances": [ "Dermatophagoides Pteronyssinus Extract", "Dermatophagoides Farinae Extract" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)" }, { "licence_number": "PA2113/002/003", "product_name": "ACTAIR 300 IR sublingual tablets", "holder": "Stallergenes", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "V01AA03" ], "active_substances": [ "Dermatophagoides Pteronyssinus Extract", "Dermatophagoides Farinae Extract" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application - change in withdrawal period (Article 19(1)(a) of Regulation (EU) 2019/6)" }, { "licence_number": "PA2118/002/003", "product_name": "Elantan 20 mg Tablets", "holder": "Merus Labs Luxco II S.à.R.L.", "authorised_date": "1983-04-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01DA", "C01DA14" ], "active_substances": [ "Isosorbid-5-mononitrat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2118/002/004", "product_name": "Elantan LA 50 mg Prolonged Release Capsules, hard", "holder": "Merus Labs Luxco II S.à.R.L.", "authorised_date": "1987-07-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C01DA", "C01DA14" ], "active_substances": [ "ISOSORBIDE MONONITRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2118/002/005", "product_name": "Elantan LA 25mg Prolonged Release Capsules", "holder": "Merus Labs Luxco II S.à.R.L.", "authorised_date": "1995-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C01DA", "C01DA14" ], "active_substances": [ "ISOSORBIDE MONONITRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2118/003/001", "product_name": "Isoket 1 mg/ml Concentrate for solution for injection or infusion, 10 ml Ampoule", "holder": "Merus Labs Luxco II S.à.R.L.", "authorised_date": "1982-12-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for injection/infusion", "atc_codes": [ "C01DA", "C01DA08" ], "active_substances": [ "Isosorbide dinitrate" ], "routes": [ "Intracoronary use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2128/002/001", "product_name": "Methadone hydrochloride 1 mg/ml oral solution", "holder": "Alkaloid - INT d.o.o", "authorised_date": "2019-09-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07BC02" ], "active_substances": [ "Methadone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2129/001/001", "product_name": "Imdur 60 mg Prolonged-release Film-coated Tablets", "holder": "Topridge Pharma (Ireland) Limited", "authorised_date": "1987-04-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01DA", "C01DA14" ], "active_substances": [ "ISOSORBIDE MONONITRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2130/001/001", "product_name": "Carbimazole 5 mg Tablets", "holder": "Essential-Healthcare Ltd.", "authorised_date": "2018-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BB", "H03BB01" ], "active_substances": [ "Carbimazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2130/001/002", "product_name": "Carbimazole 20 mg Tablets", "holder": "Essential-Healthcare Ltd.", "authorised_date": "2018-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BB", "H03BB01" ], "active_substances": [ "Carbimazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2137/001/001", "product_name": "Dexliq 4 mg/ml Oral Solution", "holder": "Laboratoires CTRS", "authorised_date": "2017-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2146/001/001", "product_name": "Nefrosol solution for haemofiltration", "holder": "B. Braun Avitum AG", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Sodium hydrogen carbonate", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2146/001/002", "product_name": "Nefrosol with 2 mmol/l Potassium solution for haemofiltration", "holder": "B. Braun Avitum AG", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Sodium hydrogen carbonate", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Glucose monohydrate", "Potassium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2146/001/003", "product_name": "Nefrosol with 4 mmol/l Potassium solution for haemofiltration", "holder": "B. Braun Avitum AG", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium chloride", "Sodium hydrogen carbonate", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Glucose monohydrate", "Potassium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2160/001/001", "product_name": "diTeBooster, suspension for injection in pre-filled single-dose syringes.Diphtheria and tetanus vaccine (adsorbed, reduced antigen content).", "holder": "AJ Vaccines A/S", "authorised_date": "2007-02-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AM", "J07AM51" ], "active_substances": [ "Diphtheria toxoid", "Tetanus toxoid" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2160/002/001", "product_name": "TdaPBooster, suspension for injection in pre-filled syringe.Diphtheria, tetanus and pertussis (acellular component) vaccine (adsorbed, reduced antigen content)", "holder": "AJ Vaccines A/S", "authorised_date": "2013-07-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AJ", "J07AJ52" ], "active_substances": [ "Diphtheria toxoid, purified", "Tetanus toxoid, purified", "Pertussis toxoid" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" }, { "licence_number": "PA2160/003/001", "product_name": "BCG VACCINE AJV", "holder": "AJ Vaccines A/S", "authorised_date": "2001-12-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "J07AN", "J07AN01" ], "active_substances": [ "Mycobacterium bovis (bcg) stam 1331" ], "routes": [ "Intradermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" }, { "licence_number": "PA2160/004/001", "product_name": "Tuberculin PPD RT23 AJV 2 T.U./0.1 mL, solution for injection", "holder": "AJ Vaccines A/S", "authorised_date": "1997-04-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V04CF", "V04CF01" ], "active_substances": [ "Tuberculin ppd" ], "routes": [ "Intradermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" }, { "licence_number": "PA2160/005/001", "product_name": "Vesiculture 30 mg/vial powder for intravesical suspension", "holder": "AJ Vaccines A/S", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for intravesical suspension", "atc_codes": [ "L03AX03" ], "active_substances": [ "MYCOBACTERIUM BOVIS, DANISH STRAIN 1331" ], "routes": [ "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/001/001", "product_name": "Atracurium besilate 10 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2017-11-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC", "M03AC04" ], "active_substances": [ "Atracurium besilate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/002/001", "product_name": "Morsadex 50 mg/2 ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M01AE", "M01AE17" ], "active_substances": [ "Dexketoprofen trometamol" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/003/001", "product_name": "Morphine sulfate 10 mg/ml Solution for Injection", "holder": "AS Kalceks", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/003/002", "product_name": "Morphine sulfate 15 mg/ml Solution for Injection", "holder": "AS Kalceks", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/003/003", "product_name": "Morphine sulfate 30 mg/ml Solution for Injection", "holder": "AS Kalceks", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/004/001", "product_name": "Rocuronium bromide 10 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/005/001", "product_name": "Oxycodone hydrochloride 10 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/005/002", "product_name": "Oxycodone hydrochloride 50 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2019-04-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA", "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/007/001", "product_name": "Sodium oxybate 500 mg/ml oral solution", "holder": "AS Kalceks", "authorised_date": "2019-11-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07XX04" ], "active_substances": [ "Sodium Oxybate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/008/001", "product_name": "Cisatracurium 2 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "M03AC11" ], "active_substances": [ "Cisatracurium Besilate", "Cisatracurium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/009/001", "product_name": "Noradrenaline (Norepinephrine) 1 mg/ml concentrate for solution for infusion", "holder": "AS Kalceks", "authorised_date": "2020-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA03" ], "active_substances": [ "Noradrenaline" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/010/001", "product_name": "Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion", "holder": "AS Kalceks", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N05CM18" ], "active_substances": [ "Dexmedetomidine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/011/001", "product_name": "Fentanyl 50 micrograms/ml solution for injection", "holder": "AS Kalceks", "authorised_date": "2020-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01AH01" ], "active_substances": [ "Fentanyl" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/012/001", "product_name": "Midazolam 5 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2020-05-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Intramuscular use", "Intravenous use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/012/002", "product_name": "Midazolam 1 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2021-12-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Intramuscular use", "Intravenous use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/013/001", "product_name": "Ondansetron 2 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/014/001", "product_name": "Dexamethasone phosphate 4 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2022-03-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Infiltration", "Intraarticular use", "Intramuscular use", "Intravenous use", "Subconjunctival use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/015/001", "product_name": "Levosimendan 2.5 mg/ml concentrate for solution for infusion", "holder": "AS Kalceks", "authorised_date": "2022-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CX08" ], "active_substances": [ "Levosimendan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/016/001", "product_name": "Meropenem 500 mg powder for solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/016/002", "product_name": "Meropenem 1 g powder for solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/017/001", "product_name": "Ceftriaxone 1 g powder for solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/017/002", "product_name": "Ceftriaxone 2 g powder for solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/020/001", "product_name": "Pantoprazole 40 mg powder for solution for injection", "holder": "AS Kalceks", "authorised_date": "2023-06-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/021/001", "product_name": "Clindamycin 150 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2024-08-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01FF01" ], "active_substances": [ "CLINDAMYCIN PHOSPHATE" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/022/001", "product_name": "Sugammadex 100 mg/ml solution for injection", "holder": "AS Kalceks", "authorised_date": "2023-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/023/001", "product_name": "Hydromorphone hydrochloride 20 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/023/002", "product_name": "Hydromorphone hydrochloride 50 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA03" ], "active_substances": [ "Hydromorphone hydrochloride" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/024/001", "product_name": "Folinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion", "holder": "AS Kalceks", "authorised_date": "2023-12-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AF03" ], "active_substances": [ "Calcium folinate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2165/025/001", "product_name": "Levetiracetam 100 mg/ml concentrate for solution for infusion", "holder": "AS Kalceks", "authorised_date": "2026-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2166/001/001", "product_name": "Nacsys 600 mg Effervescent Tablets", "holder": "Alpex Pharma (Irl) Limited", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "R05CB", "R05CB01" ], "active_substances": [ "Acetylcysteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2168/002/001", "product_name": "Meropenem 500 mg powder for solution for injection or infusion", "holder": "Acino AG", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2168/002/002", "product_name": "Meropenem 1 g powder for solution for injection or infusion", "holder": "Acino AG", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2179/001/001", "product_name": "Proursan 500 mg film-coated tablets", "holder": "PRO.MED.CS Praha a.s.", "authorised_date": "2018-07-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2179/001/002", "product_name": "Proursan 400 mg film-coated tablets", "holder": "PRO.MED.CS Praha a.s.", "authorised_date": "2021-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2179/003/001", "product_name": "REFLAD 50 mg film-coated tablets", "holder": "PRO.MED.CS Praha a.s.", "authorised_date": "2022-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A03FA07" ], "active_substances": [ "Itopride hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2200/001/001", "product_name": "Colchicine Tiofarma 500 microgram tablets", "holder": "Tiofarma B.V.", "authorised_date": "2017-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AC", "M04AC01" ], "active_substances": [ "COLCHICINE PH. EUR." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2200/001/002", "product_name": "Colchicine Tiofarma 1000 microgram tablets", "holder": "Tiofarma B.V.", "authorised_date": "2017-09-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AC", "M04AC01" ], "active_substances": [ "COLCHICINE PH. EUR." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2206/001/001", "product_name": "Rifaximin Alfasigma 550 mg film-coated tablets", "holder": "Alfasigma S.p.A", "authorised_date": "2012-12-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A07AA", "A07AA11" ], "active_substances": [ "Rifaximin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2206/002/001", "product_name": "Synacthen 250 micrograms/ml solution for injection", "holder": "Alfasigma S.p.A", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01AA", "H01AA02" ], "active_substances": [ "Tetracosactide acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2206/003/001", "product_name": "Syntocinon Ampoules 5 IU/ml solution for injection/infusion", "holder": "Alfasigma S.p.A", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01BB", "H01BB02" ], "active_substances": [ "Oxytocin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2206/003/002", "product_name": "Syntocinon Ampoules 10 IU/ml solution for injection/infusion", "holder": "Alfasigma S.p.A", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01BB", "H01BB02" ], "active_substances": [ "Oxytocin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2206/004/001", "product_name": "Zaditen 1mg/5ml oral solution", "holder": "Alfasigma S.p.A", "authorised_date": "1979-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AX", "R06AX17" ], "active_substances": [ "Ketotifen hydrogen fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2206/004/002", "product_name": "Zaditen 1 mg Tablets", "holder": "Alfasigma S.p.A", "authorised_date": "1979-12-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX17" ], "active_substances": [ "KETOTIFEN FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/001/001", "product_name": "CUTAQUIG, 165 mg/ml, solution for injection", "holder": "Octapharma (IP)", "authorised_date": "2020-05-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J06BA", "J06BA01" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/002/001", "product_name": "LG-octaplas, solution for infusion", "holder": "Octapharma (IP)", "authorised_date": "2001-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA" ], "active_substances": [ "Human plasma protein" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/002/002", "product_name": "LG-octaplas, Powder and solvent for solution for infusion", "holder": "Octapharma (IP)", "authorised_date": "2023-03-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B05AA" ], "active_substances": [ "Human plasma protein" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/004/001", "product_name": "Octanate 250 IU.Powder and solvent for solution for injection", "holder": "Octapharma (IP)", "authorised_date": "2004-06-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Human plasmafraktion (factor viii)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/004/002", "product_name": "Octanate 500 IU powder and solvent for solution for injection", "holder": "Octapharma (IP)", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Human coagulation factor viii" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/004/003", "product_name": "Octanate 1000 IU powder and solvent for solution for injection", "holder": "Octapharma (IP)", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD02" ], "active_substances": [ "Human coagulation factor viii" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/005/001", "product_name": "Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex", "holder": "Octapharma (IP)", "authorised_date": "2004-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02BD", "B02BD01" ], "active_substances": [ "Human plasma coagulation factor ix", "Human plasma coagulation factor ii", "Human plasma coagulation factor vii", "Human plasma coagulation factor x", "Protein c", "Protein s" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/005/002", "product_name": "Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex", "holder": "Octapharma (IP)", "authorised_date": "2015-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for infusion", "atc_codes": [ "B02BD", "B02BD01" ], "active_substances": [ "Human coagulation factor ix", "Human coagulation factor ii", "Human coagulation factor vii", "Human coagulation factor x", "Protein c", "Protein s" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/007/001", "product_name": "Albunorm 5%, 50 g/l, solution for infusion", "holder": "Octapharma (IP)", "authorised_date": "2009-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Human plasma protein not containing less than 96% human albumin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/007/002", "product_name": "Albunorm 20%, 200g/l, solution for infusion", "holder": "Octapharma (IP)", "authorised_date": "2009-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05AA", "B05AA01" ], "active_substances": [ "Human plasma protein not containing less than 96% human albumin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/008/001", "product_name": "Wilate, 500 IU VWF/500 IU FVIII, powder and solvent for solution for injection", "holder": "Octapharma (IP)", "authorised_date": "2012-03-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD06" ], "active_substances": [ "Human factor viii", "Von willebrand factor human" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/008/002", "product_name": "Wilate, 1000 IU VWF/1000 IU FVIII, powder and solvent for solution for injection", "holder": "Octapharma (IP)", "authorised_date": "2012-03-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "B02BD", "B02BD06" ], "active_substances": [ "Human factor viii", "Von willebrand factor human" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/010/001", "product_name": "Panzyga, 100 mg/ml solution for infusion", "holder": "Octapharma (IP)", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J06BA", "J06BA02" ], "active_substances": [ "Human normal immunoglobulin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/011/001", "product_name": "FIBRYGA, 1 g, powder and solvent for solution for injection/infusion", "holder": "Octapharma (IP)", "authorised_date": "2020-09-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B02BB01" ], "active_substances": [ "Human fibrinogen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2219/011/002", "product_name": "FIBRYGA 2 g powder and solvent for solution for injection/infusion", "holder": "Octapharma (IP)", "authorised_date": "2026-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "B02BB01" ], "active_substances": [ "Human fibrinogen" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2220/001/001", "product_name": "Voriconazole Ibisqus 200 mg powder for solution for infusion", "holder": "Instituto Biochimico Italiano G. Lorenzini S.p.A.", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AC", "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2220/002/001", "product_name": "Co-amoxiclav 500 mg/100 mg powder for solution for injection/infusion", "holder": "Instituto Biochimico Italiano G. Lorenzini S.p.A.", "authorised_date": "2019-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2220/002/002", "product_name": "Co-amoxiclav 1000 mg/200 mg powder for solution for injection/infusion", "holder": "Instituto Biochimico Italiano G. Lorenzini S.p.A.", "authorised_date": "2019-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2220/002/003", "product_name": "Co-amoxiclav 2000 mg/200 mg powder for solution for infusion", "holder": "Instituto Biochimico Italiano G. Lorenzini S.p.A.", "authorised_date": "2019-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2226/001/001", "product_name": "IELMAG3 0.2 mg kit for radiopharmaceutical preparation", "holder": "ROTOP Pharmaka GmbH", "authorised_date": "2013-08-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09CA", "V09CA03" ], "active_substances": [ "Mertiatide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2229/009/001", "product_name": "PROSTAP 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe", "holder": "Takeda Products Ireland Ltd", "authorised_date": "2011-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "L02AE", "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2229/009/002", "product_name": "PROSTAP 6 DCS 30 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe", "holder": "Takeda Products Ireland Ltd", "authorised_date": "2011-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "L02AE", "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2229/009/003", "product_name": "PROSTAP SR DCS 3.75 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe", "holder": "Takeda Products Ireland Ltd", "authorised_date": "2011-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "L02AE", "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2229/010/001", "product_name": "Protium 20 mg gastro-resistant tablets", "holder": "Takeda Products Ireland Ltd", "authorised_date": "1999-01-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2229/010/002", "product_name": "Protium 40 mg gastro-resistant tablets", "holder": "Takeda Products Ireland Ltd", "authorised_date": "1995-09-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2229/010/003", "product_name": "Protium i.v. 40 mg Powder for Solution for Injection", "holder": "Takeda Products Ireland Ltd", "authorised_date": "1998-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/001/001", "product_name": "Oxycodone hydrochloride 10mg/ml solution for injection or infusion", "holder": "hameln pharma gmbh", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N02AA05" ], "active_substances": [ "OXYCODONE HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/002/001", "product_name": "Furosemide 10 mg/ml solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2020-09-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/003/001", "product_name": "Clarithromycin 500 mg powder for concentrate for solution for infusion", "holder": "hameln pharma gmbh", "authorised_date": "2021-03-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/004/001", "product_name": "Dexamethasone Phosphate 4 mg/ml solution for injection", "holder": "hameln pharma gmbh", "authorised_date": "2021-08-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Intraarticular use", "Intrabursal use", "Intralesional use", "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/005/001", "product_name": "Daptomycin 350 mg powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2022-12-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/005/002", "product_name": "Daptomycin 500 mg powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2022-12-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/006/001", "product_name": "Voriconazole 200mg powder for solution for infusion", "holder": "hameln pharma gmbh", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/007/001", "product_name": "Vancomycin 500 mg powder for concentrate for solution for infusion", "holder": "hameln pharma gmbh", "authorised_date": "2024-08-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "A07AA09", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/007/002", "product_name": "Vancomycin 1000 mg powder for concentrate for solution for infusion", "holder": "hameln pharma gmbh", "authorised_date": "2024-08-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "A07AA09", "J01XA01" ], "active_substances": [ "VANCOMYCIN HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/008/001", "product_name": "Cefotaxime hameln 1 g powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "J01DD01" ], "active_substances": [ "Cefotaxime sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/008/002", "product_name": "Cefotaxime hameln 2 g powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for injection/infusion", "atc_codes": [ "J01DD01" ], "active_substances": [ "Cefotaxime sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/010/001", "product_name": "Ceftazidime hameln 500 mg powder for solution for injection", "holder": "hameln pharma gmbh", "authorised_date": "2025-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DD02" ], "active_substances": [ "Ceftazidime pentahydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/010/002", "product_name": "Ceftazidime hameln 1 g powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2025-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD02" ], "active_substances": [ "Ceftazidime pentahydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/010/003", "product_name": "Ceftazidime hameln 2 g powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2025-10-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD02" ], "active_substances": [ "Ceftazidime pentahydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/011/001", "product_name": "Ceftriaxone hameln 1 g powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2237/011/002", "product_name": "Ceftriaxone hameln 2 g powder for solution for injection/infusion", "holder": "hameln pharma gmbh", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2238/001/001", "product_name": "Methocarbamol 750 mg film-coated tablets", "holder": "HBS Healthcare", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M03BA", "M03BA03" ], "active_substances": [ "Methocarbamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/001/001", "product_name": "Eucardic 6.25 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1998-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AG", "C07AG02" ], "active_substances": [ "Carvedilol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/001/002", "product_name": "Eucardic 12.5 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1995-01-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AG", "C07AG02" ], "active_substances": [ "Carvedilol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/001/003", "product_name": "Eucardic 25 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1995-01-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AG", "C07AG02" ], "active_substances": [ "Carvedilol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/002/001", "product_name": "Konakion MM Ampoules 10 mg/ml Solution for Injection and Oral Solution", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1990-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B02BA", "B02BA01" ], "active_substances": [ "Phytomenadione" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/002/002", "product_name": "Konakion MM Paediatric Ampoules 2 mg/ 0.2 ml oral solution or solution for injection", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1995-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B02BA", "B02BA01" ], "active_substances": [ "Phytomenadione" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/003/001", "product_name": "Cymevene 500 mg powder for concentrate for solution for infusion", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2018-08-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J05AB", "J05AB06" ], "active_substances": [ "Ganciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/004/001", "product_name": "Fungizone 50 mg Powder for sterile concentrate", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AA", "J02AA01" ], "active_substances": [ "Amphotericin b" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/005/001", "product_name": "Questran 4g/sachet, Powder for oral suspension", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "C10AC", "C10AC01" ], "active_substances": [ "Colestyramine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/006/001", "product_name": "VEPESID 50 mg capsule, soft", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1983-10-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01CB", "L01CB01" ], "active_substances": [ "Etoposide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/006/002", "product_name": "VEPESID 100 mg capsule, soft", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1981-09-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01CB", "L01CB01" ], "active_substances": [ "Etoposide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/007/001", "product_name": "Hypnovel 10 mg/2 ml Solution for Injection", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1983-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05CD", "N05CD08" ], "active_substances": [ "Midazolam hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/007/002", "product_name": "Hypnovel 10 mg/5 ml Solution for Injection", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1985-03-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05CD", "N05CD08" ], "active_substances": [ "Midazolam hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use", "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/008/001", "product_name": "Lexotan 1.5mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1980-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA08" ], "active_substances": [ "Bromazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/008/002", "product_name": "Lexotan 3mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1980-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA08" ], "active_substances": [ "Bromazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/009/001", "product_name": "Losec MUPS 10 mg gastro-resistant tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1999-09-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/009/002", "product_name": "Losec MUPS 20 mg gastro-resistant tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1999-09-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/009/003", "product_name": "Losec MUPS 40 mg gastro-resistant tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1999-09-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole magnesium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/010/001", "product_name": "Atacand 4 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2002-04-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/010/002", "product_name": "Atacand 8 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2002-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/010/003", "product_name": "Atacand 16 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2002-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/011/001", "product_name": "Atacand Plus 8 mg/12.5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1998-11-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/011/002", "product_name": "Atacand Plus 16 mg/12.5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/013/001", "product_name": "Calcichew 500 mg chewable tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1993-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AA", "A12AA04" ], "active_substances": [ "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/013/002", "product_name": "Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1996-10-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Cholecalciferol", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/013/003", "product_name": "Calcichew-D3 Forte Double Strength 1000 mg/800 IU Chewable Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2009-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium carbonate", "Cholecalciferol concentrate (powder form)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/014/002", "product_name": "Blopress 4 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/014/003", "product_name": "Blopress 8 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/014/004", "product_name": "Blopress 16 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/014/005", "product_name": "Blopress 32 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2005-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/015/001", "product_name": "Blopress Plus 8 mg/12.5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/015/002", "product_name": "Blopress Plus 16 mg/12.5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2000-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/015/003", "product_name": "Blopress Plus 32 mg/12.5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/015/004", "product_name": "Blopress Plus 32 mg/25 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/016/001", "product_name": "Midon 2.5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1990-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA", "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/016/002", "product_name": "Midon 5 mg tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1990-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA", "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/017/001", "product_name": "One-Alpha 1 microgram soft capsules", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1978-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC03" ], "active_substances": [ "Alfacalcidol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/017/002", "product_name": "One-Alpha 0.25 micrograms soft capsules", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1978-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC03" ], "active_substances": [ "Alfacalcidol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/017/003", "product_name": "One-Alpha 2 micrograms/ml oral drops", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1999-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "A11CC", "A11CC03" ], "active_substances": [ "Alfacalcidol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/018/001", "product_name": "Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1992-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for cutaneous solution", "atc_codes": [ "D10AF", "D10AF52" ], "active_substances": [ "Erythromycin", "Zinc acetate dihydrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/019/001", "product_name": "Locoid Cream 0.1 % w/w", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1977-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AB", "D07AB02" ], "active_substances": [ "Hydrocortisone butyrate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/019/002", "product_name": "Locoid Lipocream 0.1% w/w Cream", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1984-05-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AB", "D07AB02" ], "active_substances": [ "Hydrocortisone butyrate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/020/001", "product_name": "Rivotril 0.5 mg Tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AE", "N03AE01" ], "active_substances": [ "Clonazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/021/001", "product_name": "Hydrea 500 mg Hard Capsules", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01XX", "L01XX05" ], "active_substances": [ "Hydroxycarbamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/001", "product_name": "Seroquel 25 mg film-coated tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2000-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/002", "product_name": "Seroquel 100 mg film-coated tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2000-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/005", "product_name": "Seroquel XR 50 mg prolonged-release tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2008-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/006", "product_name": "Seroquel XR 150mg prolonged-release tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2009-01-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/007", "product_name": "Seroquel XR 200mg prolonged-release tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2008-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/008", "product_name": "Seroquel XR 300mg prolonged-release tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2008-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/022/009", "product_name": "Seroquel XR 400mg prolonged-release tablets.", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2008-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/023/001", "product_name": "Valcyte 450 mg film-coated tablets", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2002-09-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB14" ], "active_substances": [ "Valganciclovir hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2239/023/002", "product_name": "Valcyte 50 mg/ml powder for oral solution", "holder": "CHEPLAPHARM Arzneimittel GmbH", "authorised_date": "2008-08-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J05AB", "J05AB14" ], "active_substances": [ "Valganciclovir hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2241/001/001", "product_name": "Leydex 12.5 mg Orodispersible Tablets", "holder": "Leyden Delta BV", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2241/001/002", "product_name": "Leydex 25 mg Orodispersible tablets", "holder": "Leyden Delta BV", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2241/001/003", "product_name": "Leydex 50 mg Orodispersible Tablets", "holder": "Leyden Delta BV", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2241/001/004", "product_name": "Leydex 100 mg Orodispersible Tablets", "holder": "Leyden Delta BV", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2241/001/005", "product_name": "Leydex 200 mg Orodispersible Tablets", "holder": "Leyden Delta BV", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/004/001", "product_name": "Zomig 2.5 mg Tablets", "holder": "Grunenthal Pharma Ltd", "authorised_date": "1998-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC03" ], "active_substances": [ "Zolmitriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/004/002", "product_name": "Zomig Rapimelt 2.5 mg orodispersible 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"registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/005/005", "product_name": "ZYDOL SR 200 mg prolonged-release tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "1997-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX02" ], "active_substances": [ "Tramadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) 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"licence_number": "PA2242/007/001", "product_name": "Versatis 700 mg medicated plaster", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "N01BB", "N01BB02" ], "active_substances": [ "Lidocaine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/001", "product_name": "Palexia 50 mg film-coated tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/002", "product_name": "Palexia 75 mg film-coated tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/003", "product_name": "Palexia 100 mg film-coated tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/004", "product_name": "Palexia SR 50 mg prolonged-release tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/007", "product_name": "Palexia SR 200 mg prolonged-release tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/008", "product_name": "Palexia SR 250 mg prolonged-release tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/012/009", "product_name": "PALEXIA SR 25 mg prolonged-release tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol 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"authorised_date": "2013-01-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02AX", "N02AX06" ], "active_substances": [ "Tapentadol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/013/001", "product_name": "Nexium 10 mg granules for gastro-resistant oral suspension in sachet", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2008-08-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for gastro-resistant oral suspension in sachet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/014/001", "product_name": "VIMOVO 500 mg/20 mg modified-release tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2010-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AE", "M01AE52" ], "active_substances": [ "Naproxen", "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/015/001", "product_name": "Nebido 1000 mg/4 ml, solution for injection", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03BA03" ], "active_substances": [ "Testosterone Undecanoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/016/001", "product_name": "Crestor 5 mg film-coated tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2005-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", 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"supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/017/001", "product_name": "Pabrinex Intravenous High Potency Concentrate for Solution for Infusion", "holder": "Grunenthal Pharma Limited.", "authorised_date": "1987-08-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "A11EB" ], "active_substances": [ "Ascorbic acid", "Riboflavin", "Pyridoxine hydrochloride", "Nicotinamide", "Thiamine hydrochloride", "Glucose (as monohydrate)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/018/001", "product_name": "Rectogesic 4 mg/g Rectal 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"atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/019/004", "product_name": "Abstral 400 microgram sublingual tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2009-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/019/005", "product_name": "Abstral 600 microgram sublingual tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2009-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2242/019/006", "product_name": "Abstral 800 microgram sublingual tablets", "holder": "Grunenthal Pharma Limited.", "authorised_date": "2009-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2243/001/001", "product_name": "Nitrolingual Pumpspray 400 micrograms per metered dose, sublingual spray", "holder": "G Pohl-Boskamp GmbH & Co. KG", "authorised_date": "1996-05-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Sublingual spray, solution", "atc_codes": [ "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2244/002/001", "product_name": "Fesoterodine Doc 4 mg prolonged-release tablets", "holder": "DOC Generici S.r.l.", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2244/002/002", "product_name": "Fesoterodine Doc 8 mg prolonged-release tablets", "holder": "DOC Generici S.r.l.", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2244/003/001", "product_name": "Ezetimibe/Atorvastatin DOC Generici 10 mg/ 10 mg film-coated tablet", "holder": "DOC Generici S.r.l.", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2244/003/002", "product_name": "Ezetimibe/Atorvastatin DOC Generici 10 mg/ 20 mg film-coated tablet", "holder": "DOC Generici S.r.l.", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2244/003/003", "product_name": "Ezetimibe/Atorvastatin DOC Generici 10 mg/ 40 mg film-coated tablet", "holder": "DOC Generici S.r.l.", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2244/003/004", "product_name": "Ezetimibe/Atorvastatin DOC Generici 10 mg/ 80 mg film-coated tablets", "holder": "DOC Generici S.r.l.", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2245/001/001", "product_name": "Dropizol 10 mg/ml Oral Drops Solution", "holder": "Atnahs Pharma Nordics A/S", "authorised_date": "2018-06-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "A07DA", "A07DA02" ], "active_substances": [ "OPIUM TINCTURE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2252/001/001", "product_name": "Trasylol 10,000 KIU/ml, solution for injection or infusion", "holder": "Nordic Group B.V.", "authorised_date": "2018-03-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B02AB", "B02AB01" ], "active_substances": [ "APROTININ CONCENTRATED SOLUTION" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/001", "product_name": "Difene 25mg Capsules", "holder": "Glenwood GmbH", "authorised_date": "1990-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/002", "product_name": "Difene 50mg Capsules", "holder": "Glenwood GmbH", "authorised_date": "1990-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/003", "product_name": "Difene 75 mg Dual Release Capsules", "holder": "Glenwood GmbH", "authorised_date": "1994-06-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/004", "product_name": "Difene 100 mg Dual Release Capsules", "holder": "Glenwood GmbH", "authorised_date": "1997-05-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/005", "product_name": "Difene 1% w/w Gel", "holder": "Glenwood GmbH", "authorised_date": "1995-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/006", "product_name": "Difene 100mg Suppositories", "holder": "Glenwood GmbH", "authorised_date": "1990-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/001/007", "product_name": "Difene Spray Gel 4% w/w Cutaneous Spray, Solution", "holder": "Glenwood GmbH", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous spray, solution", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/002/001", "product_name": "Catapres Ampoules 150 micrograms in 1 ml Solution for Injection", "holder": "Glenwood GmbH", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C02AC", "C02AC01" ], "active_substances": [ "Clonidine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/003/001", "product_name": "Catapres Tablets 100 micrograms", "holder": "Glenwood GmbH", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02AC", "C02AC01" ], "active_substances": [ "Clonidine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/004/001", "product_name": "Oramorph Oral Solution 10 mg/5 ml", "holder": "Glenwood GmbH", "authorised_date": "1990-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/004/002", "product_name": "Oramorph Concentrated oral solution 20 mg/ml", "holder": "Glenwood GmbH", "authorised_date": "1990-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02AA", "N02AA01" ], "active_substances": [ "Morphine sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/005/001", "product_name": "Plendil 2.5 mg prolonged-release tablets", "holder": "Glenwood GmbH", "authorised_date": "1997-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA", "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/005/002", "product_name": "Plendil 5 mg prolonged-release tablets", "holder": "Glenwood GmbH", "authorised_date": "1998-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA", "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2256/005/003", "product_name": "Plendil 10 mg prolonged-release tablets", "holder": "Glenwood GmbH", "authorised_date": "1998-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA", "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22575/001/001", "product_name": "Retrovir 100 mg capsules, hard", "holder": "ViiV Healthcare BV", "authorised_date": "2011-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J05AF", "J05AF01" ], "active_substances": [ "Zidovudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22575/001/002", "product_name": "Retrovir 100 mg/10 ml oral solution", "holder": "ViiV Healthcare BV", "authorised_date": "2011-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "J05AF", "J05AF01" ], "active_substances": [ "Zidovudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22575/001/003", "product_name": "Retrovir 10 mg/ml IV concentrate for solution for infusion", "holder": "ViiV Healthcare BV", "authorised_date": "2011-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J05AF", "J05AF01" ], "active_substances": [ "Zidovudine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/001/001", "product_name": "Copaxone 20 mg/ml solution for injection in pre-filled syringe", "holder": "TEVA GmbH", "authorised_date": "2004-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AX", "L03AX13" ], "active_substances": [ "Glatiramer acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/001/002", "product_name": "Copaxone 40mg/ml solution for injection in pre-filled syringe", "holder": "TEVA GmbH", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AX", "L03AX13" ], "active_substances": [ "Glatiramer acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/002/001", "product_name": "Rivaroxaban Teva 10 mg film-coated tablets", "holder": "TEVA GmbH", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/002/002", "product_name": "Rivaroxaban Teva 15 mg film-coated tablets", "holder": "TEVA GmbH", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/002/003", "product_name": "Rivaroxaban Teva 20 mg film-coated tablets", "holder": "TEVA GmbH", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/003/001", "product_name": "Eltrombopag Teva 25 mg Film-coated Tablets", "holder": "TEVA GmbH", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/003/002", "product_name": "Eltrombopag Teva 50 mg Film-coated Tablets", "holder": "TEVA GmbH", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/004/001", "product_name": "Sacubitril/Valsartan Teva 24 mg/26 mg film-coated tablets", "holder": "TEVA GmbH", "authorised_date": "2025-09-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/004/002", "product_name": "Sacubitril/Valsartan Teva 49 mg/51 mg film-coated tablets", "holder": "TEVA 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"product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/009/002", "product_name": "Rivaroxaban Teva GmbH 10 mg film-coated tablets", "holder": "TEVA GmbH", "authorised_date": "2026-07-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/010/001", "product_name": "Nintedanib Teva GmbH 100 mg Soft Capsules", "holder": "TEVA GmbH", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/010/002", "product_name": "Nintedanib Teva GmbH 150 mg Soft Capsules", "holder": "TEVA GmbH", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22579/012/001", "product_name": "Dolutegravir Teva 50 mg film-coated tablets", "holder": "TEVA GmbH", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AJ03" ], "active_substances": [ "Dolutegravir sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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"C01CA24" ], "active_substances": [ "Epinephrine" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22580/001/002", "product_name": "Anapen 300 micrograms in 0.3 ml solution for injection in a pre-filled syringe", "holder": "Bioprojet Pharma", "authorised_date": "2003-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Epinephrine" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22580/001/003", "product_name": "Anapen 500 micrograms/0.3 ml solution for injection in a pre-filled syringe", "holder": "Bioprojet Pharma", "authorised_date": "2018-08-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Epinephrine" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22580/002/001", "product_name": "Hidrasec Infants and Children 4 mg/mL Oral Suspension", "holder": "Bioprojet Pharma", "authorised_date": "2022-11-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A07XA04" ], "active_substances": [ "Racecadotril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22581/001/001", "product_name": "Duraphat 5000 ppm Fluoride Toothpaste", "holder": "Colgate-Palmolive A/S", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Toothpaste", "atc_codes": [ "A01AA", "A01AA01" ], "active_substances": [ "Sodium fluoride" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22583/001/001", "product_name": "Rapifen 500 micrograms/ml solution for injection or infusion", "holder": "Piramal Critical Care B.V.", "authorised_date": "1992-06-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N01AH", "N01AH02" ], "active_substances": [ "ALFENTANIL HYDROCHLORIDE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22583/002/001", "product_name": "Sublimaze 50 micrograms/ml solution for injection", "holder": "Piramal Critical Care B.V.", "authorised_date": "1997-06-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01AH", "N01AH01" ], "active_substances": [ "FENTANYL CITRATE" ], "routes": [ "Intravenous 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"authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye ointment", "atc_codes": [ "S01AD03" ], "active_substances": [ "Aciclovir" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22584/002/001", "product_name": "Oxybuprocaine Agepha 4 mg/ml eye drops, solution", "holder": "AGEPHA Pharma s.r.o.", "authorised_date": "2023-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01HA02" ], "active_substances": [ "Oxybuprocaine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"Prolonged-release tablet", "atc_codes": [ "N05AN", "N05AN01" ], "active_substances": [ "Lithium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22587/002/001", "product_name": "Iopidine 5 mg/ml Eye Drops, Solution", "holder": "Essential Pharma Limited", "authorised_date": "1995-04-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EA", "S01EA03" ], "active_substances": [ "Apraclonidine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22587/002/002", "product_name": "IOPIDINE 1%w/v Eye Drops, Solution", "holder": "Essential Pharma Limited", "authorised_date": "1996-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EA", "S01EA03" ], "active_substances": [ "Apraclonidine hydrochloride" ], "routes": [ "Ocular use", "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22587/003/001", "product_name": "Haldol Decanoate 50 mg/ml Solution for Injection", "holder": "Essential Pharma Limited", "authorised_date": "1993-10-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AD", "N05AD01" ], "active_substances": [ "HALOPERIDOL DECANOATE" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA22587/003/002", "product_name": "Haldol Decanoate 100 mg/ml Solution for Injection", "holder": "Essential Pharma Limited", "authorised_date": "1994-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AD", "N05AD01" ], "active_substances": [ "HALOPERIDOL DECANOATE" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA22587/004/001", "product_name": "Syntometrine 500 micrograms/5 IU solution for injection", "holder": "Essential Pharma Limited", "authorised_date": "2014-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G02AC", "G02AC01" ], "active_substances": [ "ERGOMETRINE MALEATE", "Oxytocin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/001/001", "product_name": "Deximune 25 mg Soft Capsules", "holder": "Dexcel Pharma GmbH", "authorised_date": "2007-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/001/002", "product_name": "Deximune 50 mg soft capsules", "holder": "Dexcel Pharma GmbH", "authorised_date": "2007-03-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/001/003", "product_name": "Deximune 100 mg Soft Capsules", "holder": "Dexcel Pharma GmbH", "authorised_date": "2007-03-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L04AD", "L04AD01" ], "active_substances": [ "Ciclosporin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/002/001", "product_name": "Isomel SR 60 mg Prolonged-Release Tablets", "holder": "Dexcel Pharma GmbH", "authorised_date": "1998-08-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01DA", "C01DA14" ], "active_substances": [ "Isosorbid-5-mononitrat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/006/001", "product_name": "Kwells 300 microgram Tablets", "holder": "Dexcel Pharma GmbH", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A04AD", "A04AD01" ], "active_substances": [ "Hyoscine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/007/001", "product_name": "Bisodol Antacid Chewable Tablets Calcium Carbonate 522mg Magnesium Carbonate Light 68mg Sodium Hydrogen Carbonate 64mg", "holder": "Dexcel Pharma GmbH", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AC", "A02AC01" ], "active_substances": [ "Sodium hydrogen carbonate", "Calcium carbonate", "Light magnesium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2261/008/001", "product_name": "Cymex Cream", "holder": "Dexcel Pharma GmbH", "authorised_date": "1997-04-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D08AJ", "D08AJ04" ], "active_substances": [ "Cetrimide", "Chlorocresol", "Dimeticone", "Urea" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/002/001", "product_name": "Concerta XL 18 mg prolonged-release tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2002-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride", "Methylphenidate hydrochloride", "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/002/002", "product_name": "Concerta XL 36 mg prolonged-release tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2002-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride", "Methylphenidate hydrochloride", "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/002/004", "product_name": "Concerta XL 27 mg prolonged-release tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2008-08-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/004/001", "product_name": "Durogesic DTrans 25 micrograms/hour transdermal patch", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1995-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/004/002", "product_name": "Durogesic DTrans 50 micrograms/hour Transdermal Patch", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1995-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/004/003", "product_name": "Durogesic DTrans 75 micrograms/hour Transdermal Patch", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1995-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/004/004", "product_name": "Durogesic DTrans 100 micrograms/hour transdermal patch", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1995-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/004/005", "product_name": "Durogesic DTrans 12 micrograms/hour Transdermal Patch", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2006-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/009/001", "product_name": "PARIET 10 mg gastro-resistant tablet", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1998-10-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC" ], "active_substances": [ "Rabeprazole sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/009/002", "product_name": "PARIET 20 mg gastro-resistant tablet", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1998-10-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC04" ], "active_substances": [ "Rabeprazole sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/001", "product_name": "RISPERDAL 1 mg/ml oral solution", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1996-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/002", "product_name": "RISPERDAL 6 mg film-coated tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/004", "product_name": "RISPERDAL 1 mg film-coated tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1994-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/005", "product_name": "RISPERDAL 2 mg film-coated tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1994-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/006", "product_name": "RISPERDAL 3 mg film-coated tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1994-02-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/007", "product_name": "RISPERDAL 4 mg film-coated tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1994-02-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/009", "product_name": "RISPERDAL 0.5 mg film-coated tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1996-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/010", "product_name": "RISPERDAL CONSTA 25 mg powder and solvent for prolonged-release suspension for injection", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2002-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/011", "product_name": "RISPERDAL CONSTA 37.5 mg powder and solvent for prolonged-release suspension for injection", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2002-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX", "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/010/012", "product_name": "RISPERDAL CONSTA 50 mg powder and solvent for prolonged-release suspension for injection", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "2002-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/012/002", "product_name": "Sporanox 100mg Capsules", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1996-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC02" ], "active_substances": [ "Itraconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/013/001", "product_name": "TOPAMAX 25mg Film-coated Tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1997-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/013/002", "product_name": "TOPAMAX 50mg Film-coated Tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1997-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/013/003", "product_name": "TOPAMAX 100 mg Film-coated Tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1997-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/013/004", "product_name": "TOPAMAX 200mg Film-coated Tablets", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1997-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/013/007", "product_name": "Topamax Sprinkle 15 mg Hard Capsules", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22612/013/008", "product_name": "Topamax Sprinkle 25 mg Hard Capsules", "holder": "Janssen Sciences Ireland Unlimited Company", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2262/001/001", "product_name": "Zipzoc 20%, Impregnated Dressing", "holder": "Evolan Pharma AB", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Impregnated dressing", "atc_codes": [ "D09AB", "D09AB01" ], "active_substances": [ "Zinc oxide" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2262/003/001", "product_name": "Chlorphenamine 10 mg/ml Solution for Injection", "holder": "Evolan Pharma AB", "authorised_date": "1995-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "R06AB", "R06AB04" ], "active_substances": [ "Chlorphenamine maleate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA2262/004/001", "product_name": "Glytrin 400 micrograms per metered dose Sublingual Spray", "holder": "Evolan Pharma AB", "authorised_date": "1990-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual spray, solution", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22620/001/001", "product_name": "ILUVIEN 190 micrograms intravitreal implant in applicator", "holder": "Alimera Sciences Europe Limited,", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Intravitreal implant in applicator", "atc_codes": [ "S01BA15" ], "active_substances": [ "Fluocinolone acetonide" ], "routes": [ "Intravitreal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22624/001/001", "product_name": "Utrogestan Vaginal 200 mg vaginal capsule, soft", "holder": "Besins Healthcare Ireland Limited", "authorised_date": "2019-06-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal capsule, soft", "atc_codes": [ "G03DA04" ], "active_substances": [ "PROGESTERONE, MICRONISED" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22624/001/002", "product_name": "Utrogestan Vaginal 300 mg Vaginal Capsules, soft", "holder": "Besins Healthcare Ireland Limited", "authorised_date": "2021-05-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal capsule, soft", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22624/001/004", "product_name": "Utrogestan Vaginal 400 mg soft vaginal capsules", "holder": "Besins Healthcare Ireland Limited", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Vaginal capsule, soft", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22624/002/001", "product_name": "Testosterone Besins 1000 mg/4 ml solution for injection", "holder": "Besins Healthcare Ireland Limited", "authorised_date": "2024-03-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03BA03" ], "active_substances": [ "Testosterone Undecanoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22637/008/001", "product_name": "Murine irritation & redness relief, 0.012% w/v, eye drops solution", "holder": "Elara Pharmaservices Europe Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GA01" ], "active_substances": [ "Naphazoline hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22641/002/001", "product_name": "GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe", "holder": "Chugai Pharma France", "authorised_date": "2009-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA10" ], "active_substances": [ "Lenograstim" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22641/002/002", "product_name": "GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe", "holder": "Chugai Pharma France", "authorised_date": "2009-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "L03AA", "L03AA10" ], "active_substances": [ "Lenograstim" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22643/001/001", "product_name": "Ponstan 250 mg Capsules", "holder": "Chemidex Pharma Limited", "authorised_date": "2004-03-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AG", "M01AG01" ], "active_substances": [ "Mefenamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22643/001/002", "product_name": "Ponstan Forte 500 mg Film-coated Tablets", "holder": "Chemidex Pharma Limited", "authorised_date": "2004-03-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AG", "M01AG01" ], "active_substances": [ "Mefenamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22643/001/003", "product_name": "Ponstan 500 mg capsules", "holder": "Chemidex Pharma Limited", "authorised_date": "2024-08-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule", "atc_codes": [ "M01AG01" ], "active_substances": [ "Mefenamic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22643/002/002", "product_name": "Monotrim 100 mg Tablets", "holder": "Chemidex Pharma Limited", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EA", "J01EA01" ], "active_substances": [ "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22643/002/003", "product_name": "Monotrim 200 mg Tablets", "holder": "Chemidex Pharma Limited", "authorised_date": "2009-06-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EA", "J01EA01" ], "active_substances": [ "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22643/003/001", "product_name": "Prednisolone 20 mg Rectal Foam", "holder": "Chemidex Pharma Limited", "authorised_date": "2011-02-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Rectal foam", "atc_codes": [ "D07AA", "D07AA03" ], "active_substances": [ "Prednisolone sodium metasulfobenzoate" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA22643/004/001", "product_name": "Indoramin 20 mg Film-coated Tablets", "holder": "Chemidex Pharma Limited", "authorised_date": "2008-02-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02CA", "C02CA02" ], "active_substances": [ "Indoramin base" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/001/001", "product_name": "CAMCOLIT 250 mg film-coated tablets", "holder": "Essential Pharma (M) Limited", "authorised_date": "2014-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AN", "N05AN01" ], "active_substances": [ "Lithium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/001/002", "product_name": "CAMCOLIT 400 mg film-coated tablets", "holder": "Essential Pharma (M) Limited", "authorised_date": "2014-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AN", "N05AN01" ], "active_substances": [ "Lithium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/002/001", "product_name": "Slow K 600mg Prolonged-release Coated Tablets", "holder": "Essential Pharma (M) Limited", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A12BA", "A12BA01" ], "active_substances": [ "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/003/001", "product_name": "Carbamazepine Essential Pharma 125 mg Suppositories", "holder": "Essential Pharma (M) Limited", "authorised_date": "2016-05-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/003/002", "product_name": "Carbamazepine Essential Pharma 250 mg Suppositories", "holder": "Essential Pharma (M) Limited", "authorised_date": "2016-05-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "N03AF", "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/004/001", "product_name": "Miacalcic 100 IU/ml solution for injection and infusion", "holder": "Essential Pharma (M) Limited", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H05BA", "H05BA01" ], "active_substances": [ "Calcitonin" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/004/002", "product_name": "Miacalcic 50 IU/ml solution for injection and infusion", "holder": "Essential Pharma (M) Limited", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H05BA", "H05BA01" ], "active_substances": [ "Calcitonin" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22644/005/001", "product_name": "Zarontin 250 mg/5 ml Syrup", "holder": "Essential Pharma (M) Limited", "authorised_date": "2016-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N03AD", "N03AD01" ], "active_substances": [ "Ethosuximide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/002/001", "product_name": "Nebivolol 10mg tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2014-01-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB12" ], "active_substances": [ "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/003/001", "product_name": "Levocetirizine Glenmark 5 mg Film-coated Tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2010-05-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/004/001", "product_name": "Desloratadine Glenmark 5 mg tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX", "R06AX27" ], "active_substances": [ "Desloratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/005/001", "product_name": "Escitalopram Glenmark 5 mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/005/002", "product_name": "Escitalopram Glenmark 10 mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/005/003", "product_name": "Escitalopram Glenmark 15 mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/005/004", "product_name": "Escitalopram Glenmark 20 mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/006/001", "product_name": "Atovaquone/Proguanil Hydrochloride 250 mg /100 mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2017-07-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "P01BB", "P01BB51" ], "active_substances": [ "Atovaquone", "PROGUANIL HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/007/001", "product_name": "Apremilast Glenmark 10 mg + 20 mg + 30 mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22645/007/002", "product_name": "Apremilast Glenmark 30mg film-coated tablets", "holder": "Glenmark Arzneimittel GmbH", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22647/001/001", "product_name": "Anusol Cream", "holder": "SOFIBEL", "authorised_date": "1990-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "C05AX", "C05AX04" ], "active_substances": [ "Bismuth oxide", "Balsam peru", "Zinc oxide" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22647/001/002", "product_name": "Anusol Ointment", "holder": "SOFIBEL", "authorised_date": "1990-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "C05AX", "C05AX04" ], "active_substances": [ "Bismuth subgallate", "Bismuth oxide", "Balsam peru", "Zinc oxide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22647/001/003", "product_name": "Anusol Suppositories", "holder": "SOFIBEL", "authorised_date": "1990-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "C05AX", "C05AX04" ], "active_substances": [ "Bismuth oxide", "Zinc oxide", "Balsam peru", "Bismuth subgallate" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22647/002/001", "product_name": "Anusol HC Ointment", "holder": "SOFIBEL", "authorised_date": "1990-03-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D07BA" ], "active_substances": [ "HYDROCORTISONE ACETATE", "Benzyl benzoate", "Bismuth subgallate", "Bismuth oxide", "Balsam peru", "Zinc oxide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22647/002/002", "product_name": "Anusol HC Suppositories", "holder": "SOFIBEL", "authorised_date": "1990-03-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "C05AA", "C05AA01" ], "active_substances": [ "HYDROCORTISONE ACETATE", "Benzyl benzoate", "Bismuth oxide", "Balsam peru", "Zinc oxide", "Bismuth subgallate" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2265/001/001", "product_name": "Solifenacin succinate Vivanta 5 mg film-coated tablets", "holder": "Vivanta Generics s.r.o.", "authorised_date": "2019-05-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2265/001/002", "product_name": "Solifenacin succinate Vivanta 10 mg film-coated tablets", "holder": "Vivanta Generics s.r.o.", "authorised_date": "2019-05-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2265/008/001", "product_name": "Linagliptin Vivanta 5 mg film-coated tablets", "holder": "Vivanta Generics s.r.o.", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH05" ], "active_substances": [ "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/001/001", "product_name": "Burinex 1 mg Tablets", "holder": "Karo Pharma AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA", "C03CA02" ], "active_substances": [ "Bumetanide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/001/002", "product_name": "Burinex 5 mg Tablets", "holder": "Karo Pharma AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA", "C03CA02" ], "active_substances": [ "Bumetanide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/002/001", "product_name": "Low Centyl K 1.25 mg/573 mg modified-release tablets", "holder": "Karo Pharma AB", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "C03AB", "C03AB01" ], "active_substances": [ "Bendroflumethiazide", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/002/002", "product_name": "Centyl K 2.5 mg/573 mg modified-release tablets", "holder": "Karo Pharma AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "C03AB", "C03AB01" ], "active_substances": [ "Bendroflumethiazide", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/003/001", "product_name": "Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets", "holder": "Karo Pharma AB", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CA", "J01CA08" ], "active_substances": [ "Pivmecillinam hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/004/001", "product_name": "Ultraproct 0.92 mg/g + 0.9 5mg/g + 5 mg/g Rectal Ointment", "holder": "Karo Pharma AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal ointment", "atc_codes": [ "C05AA", "C05AA08" ], "active_substances": [ "Fluocortolone pivalate", "Fluocortolone caproate", "Cinchocaine Hydrochloride" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/005/001", "product_name": "Scheriproct 1.5 mg/g + 5 mg/g rectal ointment", "holder": "Karo Pharma AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal ointment", "atc_codes": [ "C05AA", "C05AA04" ], "active_substances": [ "Prednisolone caproate", "Cinchocaine Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/005/002", "product_name": "Scheriproct 1 mg + 1 mg suppositories", "holder": "Karo Pharma AB", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "C05AA", "C05AA04" ], "active_substances": [ "Prednisolone", "Cinchocaine Hydrochloride" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/006/001", "product_name": "Gyno-Pevaryl Once 150 mg Vaginal Pessary", "holder": "Karo Pharma AB", "authorised_date": "", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G01AF", "G01AF05" ], "active_substances": [ "ECONAZOLE NITRATE" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/007/001", "product_name": "E45 Cream White Soft Paraffin 14.5% w/w Light Liquid Paraffin 12.6% w/w Anhydrous Lanolin 1.0% w/w", "holder": "Karo Pharma AB", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D02AX" ], "active_substances": [ "White soft paraffin", "Light liquid paraffin", "Lanolin anhydrous" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/008/001", "product_name": "HC45 Hydrocortisone Acetate Cream (Hydrocortisone Acetate 1% w/w)", "holder": "Karo Pharma AB", "authorised_date": "1996-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AA", "D07AA02" ], "active_substances": [ "HYDROCORTISONE ACETATE" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/009/001", "product_name": "Lamisil 1% w/w Cream", "holder": "Karo Pharma AB", "authorised_date": "1993-07-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AE", "D01AE15" ], "active_substances": [ "Terbinafine hydrochloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/009/002", "product_name": "Lamisil AT Cream", "holder": "Karo Pharma AB", "authorised_date": "2003-01-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AE", "D01AE15" ], "active_substances": [ "Terbinafine hydrochloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22650/009/003", "product_name": "Lamisil Once 1% cutaneous solution", "holder": "Karo Pharma AB", "authorised_date": "2006-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D01AE", "D01AE15" ], "active_substances": [ "Terbinafine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22654/002/001", "product_name": "Bisoprolol Fumarate 2.5 mg tablets", "holder": "Unichem Laboratories Ltd", "authorised_date": "2010-04-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22654/003/001", "product_name": "Bisocor 5 mg Tablets", "holder": "Unichem Laboratories Ltd", "authorised_date": "2001-06-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22654/003/002", "product_name": "Bisocor 10 mg Tablets", "holder": "Unichem Laboratories Ltd", "authorised_date": "2001-06-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22655/001/001", "product_name": "Osmohale, inhalation powder, hard capsule", "holder": "Pharmaxis Europe Limited", "authorised_date": "2007-10-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "V04CX" ], "active_substances": [ "Mannitol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/001/001", "product_name": "Dipentum 250mg hard Capsules", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1995-07-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A07EC", "A07EC03" ], "active_substances": [ "Olsalazine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/001/002", "product_name": "Dipentum 500mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1995-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A07EC", "A07EC03" ], "active_substances": [ "Olsalazine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/002/001", "product_name": "Naprosyn EC 250mg Gastro-resistant Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1990-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "M01AE", "M01AE02" ], "active_substances": [ "Naproxen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/002/002", "product_name": "Naprosyn EC 500mg Gastro-resistant Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1990-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "M01AE", "M01AE02" ], "active_substances": [ "Naproxen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/003/001", "product_name": "Kytril 1 mg/1 ml solution for injection", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1997-04-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA02" ], "active_substances": [ "Granisetron hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/003/002", "product_name": "Kytril 3 mg/3 ml solution for injection", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1991-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA02" ], "active_substances": [ "Granisetron hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/003/003", "product_name": "Kytril 1mg film-coated tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1994-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA02" ], "active_substances": [ "Granisetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/003/004", "product_name": "Kytril 2mg film-coated tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1998-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA02" ], "active_substances": [ "Granisetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/004/001", "product_name": "Frisium 10mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1980-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/005/001", "product_name": "Stemetil 12.5 mg/ml solution for injection - 1 ml Ampoule", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AB", "N05AB04" ], "active_substances": [ "PROCHLORPERAZINE MESILATE" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/005/002", "product_name": "Stemetil 5mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AB", "N05AB04" ], "active_substances": [ "Prochlorperazine maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/006/001", "product_name": "Zestoretic 10 mg /12.5 mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "2000-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA", "C09BA03" ], "active_substances": [ "Lisinopril Dihydrate", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/006/002", "product_name": "Zestoretic 20 mg/12.5 mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1997-10-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA", "C09BA03" ], "active_substances": [ "Hydrochlorothiazide", "lisinopril anhydrous" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/007/001", "product_name": "Zestril 5mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1989-05-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/007/002", "product_name": "Zestril 10 mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1989-05-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22657/007/003", "product_name": "Zestril 20mg Tablets", "holder": "Atnahs Pharma Netherlands B.V.", "authorised_date": "1989-05-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22661/001/001", "product_name": "SeHCAT 370kBq capsules", "holder": "GE Healthcare Buchler GmbH & Co KG", "authorised_date": "1989-11-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "V09DX", "V09DX01" ], "active_substances": [ "Tauroselcholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to Restricted Prescription (C)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22662/004/001", "product_name": "Clobazam Essential Pharmaceuticals 1 mg/ml oral suspension", "holder": "Essential Pharmaceuticals Limited", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/004/001", "product_name": "Vonodiol 100 mcg/20 mcg Film-coated Tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2009-08-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA07" ], "active_substances": [ "Levonorgestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/005/001", "product_name": "Veyann 0.02 mg/3 mg Film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2012-11-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Drospirenone", "Ethinyl estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/006/001", "product_name": "Dretinelle 0.02 mg/3 mg Film-coated Tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA17" ], "active_substances": [ "Ethinylestradiol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/007/001", "product_name": "Dretine 0.03 mg/3 mg Film-coated Tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2009-10-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AA", "G03AA12" ], "active_substances": [ "Ethinylestradiol", "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/008/001", "product_name": "Evorel 50 micrograms per 24 hours Transdermal Patch", "holder": "Theramex Ireland Limited", "authorised_date": "", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol hemihydrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/009/001", "product_name": "Evorel Conti 50/170 micrograms per 24 hours Transdermal Patch", "holder": "Theramex Ireland Limited", "authorised_date": "", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA53" ], "active_substances": [ "Estradiol hemihydrate", "Norethisterone acetate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/013/001", "product_name": "Duphaston 10 mg film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "1985-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03DB", "G03DB01" ], "active_substances": [ "Dydrogesterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/014/001", "product_name": "Femoston 1/10mg film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "1998-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FB", "G03FB08" ], "active_substances": [ "Dydrogesterone", "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/014/002", "product_name": "Femoston 2/10mg film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "1997-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FB", "G03FB08" ], "active_substances": [ "Dydrogesterone", "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/014/003", "product_name": "Femoston-conti 0.5 mg/2.5 mg film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA14" ], "active_substances": [ "Estradiol", "Dydrogesterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/014/004", "product_name": "Femoston-conti 1 mg/5 mg film-coated tablets", "holder": "Theramex Ireland Limited", "authorised_date": "2000-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA14" ], "active_substances": [ "Estradiol", "Dydrogesterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22668/015/001", "product_name": "Fematab 1mg film-coated tablet", "holder": "Theramex Ireland Limited", "authorised_date": "1999-04-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/001/001", "product_name": "Laxido Orange, powder for oral solution", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2008-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/001/002", "product_name": "Laxido, powder for oral solution", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2008-07-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/001/003", "product_name": "Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution in sachet", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/004/001", "product_name": "Erdotin 300 mg capsules", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "R05CB", "R05CB15" ], "active_substances": [ "Erdosteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/005/001", "product_name": "THORENS 10 000 I.U. /ml oral drops, solution", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2014-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/005/002", "product_name": "THORENS 25 000 I.U. /2.5 ml oral solution", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2014-02-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22680/005/003", "product_name": "Thorens 25 000 I.U. capsules, hard", "holder": "Galen Pharma Ireland Limited", "authorised_date": "2019-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/002/001", "product_name": "Ezetimibe/Atorvastatin Althera 10 mg/10 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/002/002", "product_name": "Ezetimibe/Atorvastatin Althera 10 mg/20 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/002/003", "product_name": "Ezetimibe/Atorvastatin Althera 10 mg/40 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/002/004", "product_name": "Ezetimibe/Atorvastatin Althera 10 mg/80 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/004/001", "product_name": "Ezetimibe/Atorvastatin 10 mg/10 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/004/002", "product_name": "Ezetimibe/Atorvastatin 10 mg/20 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/004/003", "product_name": "Ezetimibe/Atorvastatin 10 mg/40 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22683/004/004", "product_name": "Ezetimibe/Atorvastatin 10 mg/80 mg film-coated tablets", "holder": "Althera Laboratories Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22695/001/001", "product_name": "Golden Eye 0.1% w/v Eye drops, solution", "holder": "Cambridge Healthcare Ireland Limited", "authorised_date": "1993-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AX", "S01AX15" ], "active_substances": [ "Propamidine isetionate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA22695/001/002", "product_name": "Golden Eye 0.15% w/w Eye Ointment", "holder": "Cambridge Healthcare Ireland Limited", "authorised_date": "1993-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye ointment", "atc_codes": [ "S01AX", "S01AX14" ], "active_substances": [ "Dibromopropamidine isethionate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA22696/001/001", "product_name": "Iruxol Mono 1.2 U/g Ointment", "holder": "Smith & Nephew GmbH", "authorised_date": "1990-09-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D03BA", "D03BA52" ], "active_substances": [ "Protease", "Clostridiopeptidase a" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Competence of personnel (Article 23 of Directive No 2010/63/EU)" }, { "licence_number": "PA22697/001/001", "product_name": "Aciclovir 200 mg/5ml Oral Suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/001/002", "product_name": "Aciclovir 400 mg/5ml Oral Suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/002/001", "product_name": "Amitriptyline hydrochloride 10 mg/5 ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2015-04-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06AA", "N06AA09" ], "active_substances": [ "Amitriptyline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/002/002", "product_name": "Amitriptyline hydrochloride 25 mg/5 ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2015-04-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06AA", "N06AA09" ], "active_substances": [ "Amitriptyline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/002/003", "product_name": "Amitriptyline hydrochloride 50 mg/5 ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2015-04-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06AA", "N06AA09" ], "active_substances": [ "Amitriptyline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/003/001", "product_name": "Amlodipine Thame 5mg/5ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2015-08-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/003/002", "product_name": "Amlodipine Thame 10 mg/5 ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2015-08-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/005/001", "product_name": "Baclofen 5 mg/5 ml oral solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "M03BX", "M03BX01" ], "active_substances": [ "Baclofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/006/001", "product_name": "Clobazam Thame 5 mg/5 ml Oral Suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N05BA", "N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/006/002", "product_name": "Clobazam Thame 10 mg/5 ml Oral Suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-02-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N05BA", "N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/010/001", "product_name": "Fluoxetine 20 mg/ 5 ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-05-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06AB", "N06AB03" ], "active_substances": [ "FLUOXETINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/012/001", "product_name": "Levetiracetam Thame 100 mg/ml oral solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/013/001", "product_name": "Ondansetron 4 mg/5 ml syrup", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2018-08-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/015/001", "product_name": "Sodium chloride 5 mmol/ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A12CA01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/016/001", "product_name": "Syrisal 1 mmol/ml oral solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2016-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A12CA", "A12CA01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/017/001", "product_name": "Thamicarb 84 mg/ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A02AH" ], "active_substances": [ "Sodium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/018/001", "product_name": "Lamotrigine SyriMed 5mg/ml Oral Suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2022-09-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/019/001", "product_name": "Bisoprolol Syri Pharma 0.5 mg/ml", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2025-06-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/020/001", "product_name": "Clonidine hydrochloride 100 micrograms/ 5 ml Oral Solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2025-08-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C02AC01" ], "active_substances": [ "Clonidine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/021/001", "product_name": "Tolterodine tartrate 0.4 mg/ml oral suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/022/001", "product_name": "Diazepam 0.4 mg/ml oral suspension", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N05BA01" ], "active_substances": [ "Diazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/025/001", "product_name": "Gabapentin Thame 50 mg/ml oral solution", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22697/026/001", "product_name": "Kay-Cee-L Syrup 7.5% w/v", "holder": "Syri Pharma Limited t/a Thame Laboratories", "authorised_date": "1977-02-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "A12BA", "A12BA01" ], "active_substances": [ "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22698/022/001", "product_name": "Nitoman 25 mg Tablets", "holder": "Bausch Health Ireland Limited", "authorised_date": "2011-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07XX", "N07XX06" ], "active_substances": [ "Tetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22698/024/001", "product_name": "Megace 40 mg/ml Oral Suspension", "holder": "Bausch Health Ireland Limited", "authorised_date": "1998-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "L02AB", "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22698/028/001", "product_name": "Megace 160 mg tablets", "holder": "Bausch Health Ireland Limited", "authorised_date": "1989-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02AB", "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22701/003/001", "product_name": "Gliadel 7.7 mg Implant", "holder": "Clinigen Healthcare B.V.", "authorised_date": "1999-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "L01AD", "L01AD01" ], "active_substances": [ "Carmustine" ], "routes": [ "Intralesional use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22702/001/001", "product_name": "Derbac M Liquid 0.5% w/w cutaneous emulsion", "holder": "LanesHealth (Ireland) Limited", "authorised_date": "1993-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous emulsion", "atc_codes": [ "P03AX", "P03AX03" ], "active_substances": [ "Malathion" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22702/002/001", "product_name": "Olbas Oil", "holder": "LanesHealth (Ireland) Limited", "authorised_date": "1988-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, liquid", "atc_codes": [ "R05X" ], "active_substances": [ "Cajuput oil", "Clove oil", "Eucalyptus oil", "Juniper oil", "Mint oil, partly dementholised", "Methyl salicylate", "Menthol" ], "routes": [ "Inhalation use", "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22702/002/003", "product_name": "Olbas Inhaler nasal stick", "holder": "LanesHealth (Ireland) Limited", "authorised_date": "1997-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal stick", "atc_codes": [ "R01AX" ], "active_substances": [ "Cajuput oil", "Levomenthol", "Eucalyptus oil", "Peppermint oil" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22702/003/001", "product_name": "Audax Ear Drops Solution Choline Salicylate 20%w/v Glycerol 12.6%w/v", "holder": "LanesHealth (Ireland) Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Ear drops, solution", "atc_codes": [ "S02DA" ], "active_substances": [ "Choline salicylate", "Glycerol" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22703/001/001", "product_name": "Ilvico Cold and Flu film-coated tablets Paracetamol 325 mg Caffeine 30 mg Brompheniramine maleate 3 mg", "holder": "P&G Health Germany GmbH", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AB", "R06AB51" ], "active_substances": [ "Paracetamol", "BROMPHENIRAMINE MALEATE", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22714/001/001", "product_name": "Citidaron 1.5 mg tablets", "holder": "Aflofarm Farmacja Polska Sp. z o.o.", "authorised_date": "2018-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07BA" ], "active_substances": [ "Cytisine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22716/002/001", "product_name": "Sugammadex Juta 100 mg/ml solution for injection", "holder": "Juta Pharma GmbH", "authorised_date": "2023-07-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/001/001", "product_name": "Nabumetone Tillomed 500 mg Film-coated Tablets", "holder": "Tillomed Pharma GmbH", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX01" ], "active_substances": [ "Nabumetone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/002/001", "product_name": "Beta-Prograne 160mg Prolonged-Release Capsules", "holder": "Tillomed Pharma GmbH", "authorised_date": "1994-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C07AA", "C07AA05" ], "active_substances": [ "Propranolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/002/002", "product_name": "Half Beta-Prograne 80 mg Prolonged-Release Capsules", "holder": "Tillomed Pharma GmbH", "authorised_date": "1999-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "C07AA", "C07AA05" ], "active_substances": [ "Propranolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/003/001", "product_name": "Carmustine 100 mg powder and solvent for concentrate for solution for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2020-01-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for concentrate for solution for infusion", "atc_codes": [ "L01AD", "L01AD01" ], "active_substances": [ "Carmustine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/006/001", "product_name": "Melphalan Tillomed 50 mg powder and solvent for solution for injection/infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection/infusion", "atc_codes": [ "L01AA", "L01AA03" ], "active_substances": [ "Melphalan Hydrochloride" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/008/001", "product_name": "Emtricitabine/Tenofovir disoproxil Tillomed 200 mg/245 mg film-coated tablets", "holder": "Tillomed Pharma GmbH", "authorised_date": "2020-10-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Emtricitabine", "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/009/001", "product_name": "Foscarnet sodium hexahydrate Tillomed 24 mg/ml solution for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J05AD01" ], "active_substances": [ "Foscarnet Sodium Hexahydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/011/001", "product_name": "Treprostinil Tillomed 1 mg/ml solution for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/011/002", "product_name": "Treprostinil Tillomed 2.5 mg/ml solution for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/011/003", "product_name": "Treprostinil Tillomed 5 mg/ml solution for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/011/004", "product_name": "Treprostinil Tillomed 10 mg/ml solution for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC21" ], "active_substances": [ "Treprostinil" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/013/001", "product_name": "Pentamidine Tillomed 300 mg powder for solution for injection/infusion or powder for nebuliser solution", "holder": "Tillomed Pharma GmbH", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "P01CX01" ], "active_substances": [ "Pentamidine isethionate" ], "routes": [ "Inhalation use", "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22720/016/001", "product_name": "Amphotericin B Liposomal Tillomed 50 mg Powder for concentrate for dispersion for infusion", "holder": "Tillomed Pharma GmbH", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for dispersion for infusion", "atc_codes": [ "J02AA01" ], "active_substances": [ "Amphotericin b" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2273/001/001", "product_name": "Fluorescein 100 mg/ml solution for injection", "holder": "Pharmargus Limited", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "S01JA01" ], "active_substances": [ "Fluorescein sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22735/002/001", "product_name": "Isotretinoin GAP 10 mg capsule, soft", "holder": "Gap S.A.", "authorised_date": "2021-05-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22735/002/002", "product_name": "Isotretinoin GAP 20 mg capsule, soft", "holder": "Gap S.A.", "authorised_date": "2021-05-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/001/001", "product_name": "Acnecide 5% w/w Gel", "holder": "Galderma International", "authorised_date": "1984-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AE", "D10AE01" ], "active_substances": [ "Benzoyl Peroxide" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/001/002", "product_name": "Acnecide Wash 5 % w/w Gel", "holder": "Galderma International", "authorised_date": "1997-10-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AE", "D10AE01" ], "active_substances": [ "Benzoyl Peroxide" ], "routes": [ "Cutaneous use", "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/003/001", "product_name": "Calmurid HC 10%/5%/1% w/w Cream", "holder": "Galderma International", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07XA", "D07XA01" ], "active_substances": [ "Hydrocortisone", "Urea", "Lactic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/004/001", "product_name": "Curanail 5% w/v medicated nail lacquer", "holder": "Galderma International", "authorised_date": "2012-03-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated nail lacquer", "atc_codes": [ "D01AE", "D01AE16" ], "active_substances": [ "Amorolfine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/005/001", "product_name": "Differin 0.1% w/w Cream", "holder": "Galderma International", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AD", "D10AD03" ], "active_substances": [ "Adapalene" ], "routes": [ "Cutaneous use", "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/005/002", "product_name": "Differin 0.1% w/w Gel", "holder": "Galderma International", "authorised_date": "1994-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AD", "D10AD03" ], "active_substances": [ "Adapalene" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/006/001", "product_name": "EFRACEA 40 mg modified-release hard capsules", "holder": "Galderma International", "authorised_date": "2009-01-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "J01AA02" ], "active_substances": [ "Doxycycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/007/001", "product_name": "Epiduo 0.1%/2.5% gel", "holder": "Galderma International", "authorised_date": "2017-05-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AD53" ], "active_substances": [ "Adapalene", "Benzoyl Peroxide" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/007/002", "product_name": "Epiduo 0.3 %/2.5 % gel", "holder": "Galderma International", "authorised_date": "2022-10-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AD53" ], "active_substances": [ "Adapalene", "Anhydrous Benzoyl Peroxide" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/008/001", "product_name": "Etrivex 500 micrograms/g shampoo", "holder": "Galderma International", "authorised_date": "2007-04-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D07AD", "D07AD01" ], "active_substances": [ "Clobetasol propionate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/009/001", "product_name": "Loceryl 5% w/v Medicated Nail Lacquer", "holder": "Galderma International", "authorised_date": "1993-03-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated nail lacquer", "atc_codes": [ "D01AE", "D01AE16" ], "active_substances": [ "Amorolfine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/010/001", "product_name": "Metvix 160 mg/g cream", "holder": "Galderma International", "authorised_date": "2002-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "L01XD", "L01XD03" ], "active_substances": [ "METHYL AMINOLEVULINATE HYDROCHLORIDE" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/013/001", "product_name": "Rozex 7.5 mg/g Gel", "holder": "Galderma International", "authorised_date": "1991-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D06BX", "D06BX01" ], "active_substances": [ "Metronidazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/013/002", "product_name": "Rozex 7.5 mg/g Cream", "holder": "Galderma International", "authorised_date": "1998-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BX", "D06BX01" ], "active_substances": [ "Metronidazole" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/014/001", "product_name": "Silkis 3 micrograms per g ointment", "holder": "Galderma International", "authorised_date": "2006-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D05AX", "D05AX03" ], "active_substances": [ "Calcitriol" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/015/001", "product_name": "Soolantra 10 mg/g Cream", "holder": "Galderma International", "authorised_date": "2015-04-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D11AX", "D11AX22" ], "active_substances": [ "Ivermectin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/016/001", "product_name": "Tetralysal 300mg Hard Capsules", "holder": "Galderma International", "authorised_date": "1982-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA", "J01AA04" ], "active_substances": [ "Lymecycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22743/017/001", "product_name": "Aklief 50 microgram/g Cream", "holder": "Galderma International", "authorised_date": "2020-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AD06" ], "active_substances": [ "Trifarotene" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22745/001/001", "product_name": "Penthrox 99.9%, 3 ml inhalation vapour, liquid", "holder": "Medical Developments MD&P Limited", "authorised_date": "2015-11-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, liquid", "atc_codes": [ "N02BG", "N02BG09" ], "active_substances": [ "Methoxyflurane" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22745/002/001", "product_name": "Methoxyflurane Medical Developments MD&P 99.9%, 3 ml inhalation vapour, liquid", "holder": "Medical Developments MD&P Limited", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, liquid", "atc_codes": [ "N02BG09" ], "active_substances": [ "Methoxyflurane" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/001/001", "product_name": "Furosemide Bristol 20 mg Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/001/002", "product_name": "Furosemide Bristol 40 mg Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/002/001", "product_name": "Fluoxetine 20mg Hard Capsules", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2012-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB", "N06AB03" ], "active_substances": [ "Fluoxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/002/002", "product_name": "Fluoxetine 60 mg Hard Capsules", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2012-07-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AB", "N06AB03" ], "active_substances": [ "Fluoxetine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/003/001", "product_name": "Levocetirizine dihydrochloride 5 mg Film-Coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/004/001", "product_name": "Donepezil Hydrochloride 5mg Film-coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2013-03-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/004/002", "product_name": "Donepezil Hydrochloride 10mg Film-coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2013-03-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/005/001", "product_name": "Paracetamol/Caffeine 500mg/65mg Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Anhydrous caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/006/001", "product_name": "Gliclazide MR 30 mg prolonged-release tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A10BB", "A10BB09" ], "active_substances": [ "Gliclazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/007/001", "product_name": "Esomeprazole 20 mg gastro-resistant tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/007/002", "product_name": "Esomeprazole 40 mg gastro-resistant tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/008/001", "product_name": "Escitalopram 5 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/008/002", "product_name": "Escitalopram 10 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/008/003", "product_name": "Escitalopram 15 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/008/004", "product_name": "Escitalopram 20 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/009/001", "product_name": "Paracetamol/Codeine 500 mg/30 mg, effervescent tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AJ", "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/011/001", "product_name": "Brillphalac 3.335 g/5 ml oral solution", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2016-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD", "A06AD11" ], "active_substances": [ "Lactulose" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/012/001", "product_name": "Telmisartan 20 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/012/002", "product_name": "Telmisartan 40 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/012/003", "product_name": "Telmisartan 80 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2016-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/014/001", "product_name": "Majoven XL 37.5mg Prolonged Release Capsules, Hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-01-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/014/002", "product_name": "Majoven XL 75 mg prolonged-release capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-01-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/014/003", "product_name": "Majoven XL 150mg Prolonged Release Capsules, Hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-01-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/001", "product_name": "Pregabalin 25 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/002", "product_name": "Pregabalin 50 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/003", "product_name": "Pregabalin 75 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/004", "product_name": "Pregabalin 100 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/005", "product_name": "Pregabalin 150 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/006", "product_name": "Pregabalin 200 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/007", "product_name": "Pregabalin 225 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/015/008", "product_name": "Pregabalin 300 mg capsules, hard", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AX", "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/016/001", "product_name": "Aripiprazole 5 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/016/002", "product_name": "Aripiprazole 10 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/016/003", "product_name": "Aripiprazole 15 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/016/004", "product_name": "Aripiprazole 20 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/016/005", "product_name": "Aripiprazole 30 mg tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AX", "N05AX12" ], "active_substances": [ "Aripiprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/017/001", "product_name": "Rosuvastatin 5 mg Film-coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/017/002", "product_name": "Rosuvastatin 10 mg Film-coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/017/003", "product_name": "Rosuvastatin 20 mg Film-coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/017/004", "product_name": "Rosuvastatin 40 mg Film-coated Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/018/001", "product_name": "Etoricoxib 30 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/018/002", "product_name": "Etoricoxib 60 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/018/003", "product_name": "Etoricoxib 90 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/018/004", "product_name": "Etoricoxib 120 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH", "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/019/001", "product_name": "Levetiracetam Brillpharma 100 mg/ml oral solution", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-03-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX", "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/020/001", "product_name": "Tadalafil 2.5mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/020/004", "product_name": "Tadalafil 20mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2017-05-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE", "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/021/001", "product_name": "Bendroflumethiazide 2.5 mg Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2018-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03AA01" ], "active_substances": [ "Bendroflumethiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/021/002", "product_name": "Bendroflumethiazide 5 mg Tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2018-11-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03AA01" ], "active_substances": [ "Bendroflumethiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/022/004", "product_name": "Ibuprofen 200 mg soft capsules", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2019-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen ph. eur." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/023/001", "product_name": "Esomeprazole 20 mg gastro-resistant tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2018-03-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/024/001", "product_name": "Flucloxacillin 125 mg/5 ml Powder for Oral Solution, Sugar Free", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/024/002", "product_name": "Flucloxacillin 250 mg/5 ml Powder for Oral Solution, Sugar Free", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2020-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22749/025/001", "product_name": "Hydroxyzine hydrochloride 25 mg film-coated tablets", "holder": "Brillpharma (Ireland) Limited", "authorised_date": "2022-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05BB", "N05BB01" ], "active_substances": [ "Hydroxyzine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22753/001/001", "product_name": "Minoxidil for men 5% w/v cutaneous solution", "holder": "Careforsons Ireland Limited", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D11AX01" ], "active_substances": [ "Minoxidil" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22753/002/001", "product_name": "Finasteride 1mg film-coated tablets", "holder": "Careforsons Ireland Limited", "authorised_date": "2020-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "D11AX10" ], "active_substances": [ "Finasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22757/001/001", "product_name": "Voquily 1 mg/ml oral solution", "holder": "RAD Neurim Pharmaceuticals EEC SARL", "authorised_date": "2022-08-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05CH01" ], "active_substances": [ "Melatonin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/001/003", "product_name": "Humulin S (Soluble) 100 IU/ml Solution for Injection in vial", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in vial", "atc_codes": [ "A10AB", "A10AB01" ], "active_substances": [ "Human insulin (recombinant dna origin)" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/001/004", "product_name": "Humulin S (Soluble), 100 IU/ml Solution for Injection in cartridge", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "A10AB01" ], "active_substances": [ "Human insulin (recombinant dna origin)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/002/003", "product_name": "Humulin I (Isophane) 100 IU/ml Suspension for Injection in vial", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Human insulin (recombinant dna 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"PA2276/003/003", "product_name": "Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in vial", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Human insulin (recombinant dna origin)" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/003/004", "product_name": "Humulin M3 (Mixture 3) 100 IU/ml Suspension for Injection in cartridge", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in cartridge", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Human insulin (recombinant dna origin)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/005/002", "product_name": "Humulin I KwikPen (Isophane) 100 IU/ml Suspension for Injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AC", "A10AC01" ], "active_substances": [ "Human insulin (recombinant dna origin)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/006/002", "product_name": "Humulin M3 KwikPen (mixture 3) 100 IU/ml Suspension for Injection", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection", "atc_codes": [ "A10AD", "A10AD01" ], "active_substances": [ "Human insulin (recombinant dna origin)" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2276/007/008", "product_name": "Strattera 4 mg/mL oral solution", "holder": "Eli Lilly Nederland B.V.", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06BA", "N06BA09" ], "active_substances": [ "ATOMOXETINE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22760/001/001", "product_name": "Labetalol 5 mg/ml solution for injection/ infusion", "holder": "S.A.L.F. S.p.A. Laboratorio Farmacologico", "authorised_date": "2019-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C07AG01" ], "active_substances": [ "Labetalol hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/001/001", "product_name": "Docetaxel 20 mg/ml concentrate for solution for infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2011-08-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CD", "L01CD02" ], "active_substances": [ "Docetaxel (anhydrous)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/002/001", "product_name": "Pemetrexed Seacross 100 mg powder for concentrate for solution for infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2017-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/002/002", "product_name": "Pemetrexed Seacross 500 mg powder for concentrate for solution for infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2017-05-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/003/001", "product_name": "Epirubicin 2 mg/ml Solution for Injection", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01DB", "L01DB03" ], "active_substances": [ "Epirubicin hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/004/001", "product_name": "Doxorubicin 2 mg/ml Concentrate for Solution for Infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2010-01-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01DB", "L01DB01" ], "active_substances": [ "DOXORUBICIN HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/005/001", "product_name": "Azacitidine Seacross 25 mg/ml powder for suspension for injection", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for suspension for injection", "atc_codes": [ "L01BC07" ], "active_substances": [ "Azacitidine" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/007/001", "product_name": "Plerixafor Seacross 20 mg/ml solution for injection", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L03AX16" ], "active_substances": [ "Plerixafor" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/009/001", "product_name": "Voriconazole Seacross 200 mg powder for solution for infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/010/001", "product_name": "Zoledronic acid Seacross 5 mg solution for infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "M05BA08" ], "active_substances": [ "Zoledronic acid monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/011/001", "product_name": "Teicoplanin Seacross 200 mg powder for solution for injection/infusion or oral solution", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/011/002", "product_name": "Teicoplanin Seacross 400 mg powder for solution for injection/infusion or oral solution", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XA02" ], "active_substances": [ "Teicoplanin" ], "routes": [ "Intramuscular use", "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/012/001", "product_name": "Sodium Valproate Seacross 100 mg/ml solution for injection/infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-08-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N03AG01" ], "active_substances": [ "Sodium valproate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/013/001", "product_name": "Cyclophosphamide Seacross 200 mg powder for solution for injection/infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-12-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01AA01" ], "active_substances": [ "Cyclophosphamide monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/013/002", "product_name": "Cyclophosphamide Seacross 500 mg powder for solution for injection/infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-12-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01AA01" ], "active_substances": [ "Cyclophosphamide monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/013/003", "product_name": "Cyclophosphamide Seacross 1000 mg powder for solution for injection/infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-12-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01AA01" ], "active_substances": [ "Cyclophosphamide monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/013/004", "product_name": "Cyclophosphamide Seacross 2000 mg powder for solution for injection/infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2024-12-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "L01AA01" ], "active_substances": [ "Cyclophosphamide monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22766/015/001", "product_name": "Apacross 5 mg/ml powder for dispersion for infusion", "holder": "Seacross Pharma (Europe) Limited", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for dispersion for infusion", "atc_codes": [ "L01CD01" ], "active_substances": [ "Paclitaxel" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22773/001/001", "product_name": "Ibuprofen Banner 100 mg soft chewable capsules", "holder": "Patheon Softgels B.V.", "authorised_date": "2019-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable capsule, soft", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22778/002/001", "product_name": "Fibrovein 0.2% Solution for Injection", "holder": "STD Pharmaceutical (Ireland) Limited", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C05BB04" ], "active_substances": [ "Sodium tetradecyl sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22778/002/002", "product_name": "Fibrovein 0.5% Solution for Injection", "holder": "STD Pharmaceutical (Ireland) Limited", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C05BB04" ], "active_substances": [ "Sodium tetradecyl sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22778/002/003", "product_name": "Fibrovein 1% Solution for Injection", "holder": "STD Pharmaceutical (Ireland) Limited", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C05BB04" ], "active_substances": [ "Sodium tetradecyl sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22778/002/004", "product_name": "Fibrovein 3% Solution for Injection", "holder": "STD Pharmaceutical (Ireland) Limited", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C05BB04" ], "active_substances": [ "Sodium tetradecyl sulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22784/001/001", "product_name": "Appizped 10mg/15ml oral solution", "holder": "Proveca Pharma Limited", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22784/001/002", "product_name": "Appizped 20 mg/15ml oral solution", "holder": "Proveca Pharma Limited", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22808/001/001", "product_name": "Idrolax 10g, powder for oral solution in a sachet", "holder": "Mayoly Pharma France", "authorised_date": "2002-02-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution in sachet", "atc_codes": [ "A06AD", "A06AD15" ], "active_substances": [ "Macrogol 4000" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22815/001/001", "product_name": "Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed", "holder": "Glenmark Pharmaceuticals Nordic AB", "authorised_date": "2019-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22815/002/001", "product_name": "Tiogiva, 18 microgram, inhalation powder, hard capsule", "holder": "Glenmark Pharmaceuticals Nordic AB", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03BB04" ], "active_substances": [ "Tiotropium bromide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22835/005/001", "product_name": "Droperidol 0.5 mg/ml solution for injection", "holder": "Sintetica GmbH", "authorised_date": "2023-07-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AD08" ], "active_substances": [ "Droperidol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2284/001/001", "product_name": "Ropivacaine Readyfusor 10 mg/h solution for infusion in administration system", "holder": "BioQ Pharma B.V.", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for infusion in administration system", "atc_codes": [ "N01BB", "N01BB09" ], "active_substances": [ "Ropivacaine hydrochloride monohydrate" ], "routes": [ "Perineural use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22852/001/001", "product_name": "Medical Oxygen", "holder": "Air Liquide Healthcare Ireland Limited", "authorised_date": "2015-05-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, compressed", "atc_codes": [ "V03AN", "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22852/001/002", "product_name": "Medical Liquid Oxygen 100% Medicinal gas, cryogenic", "holder": "Air Liquide Healthcare Ireland Limited", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicinal gas, cryogenic", "atc_codes": [ "V03AN01" ], "active_substances": [ "Oxygen" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/001/001", "product_name": "Crinone 8% w/w progesterone vaginal gel", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "1997-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal gel", "atc_codes": [ "G03DA", "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/004/001", "product_name": "Cardicor 1.25 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/004/002", "product_name": "Cardicor 2.5 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/004/003", "product_name": "Cardicor 3.75 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/004/004", "product_name": "Cardicor 5 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/004/005", "product_name": "Cardicor 7.5 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/004/006", "product_name": "Cardicor 10 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2000-03-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "Bisoprolol hemifumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/005/001", "product_name": "Glucophage 500 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "1983-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/005/002", "product_name": "Glucophage 850 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "1983-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/005/003", "product_name": "Glucophage 1000 mg film-coated tablets", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/006/001", "product_name": "Saizen 5.83 mg/ml solution for injection in cartridge", "holder": "Merck Serono (Ireland) Limited", "authorised_date": "2011-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in cartridge", "atc_codes": [ "H01AC", "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2286/006/002", "product_name": "Saizen 8 mg/ml solution for 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[ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/001/001", "product_name": "Pyranistole 200 mg prolonged release capsules", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2018-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "B01AC", "B01AC07" ], "active_substances": [ "Dipyridamole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/002/001", "product_name": "Colchicine 500 microgram Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AC", "M04AC01" ], "active_substances": [ "Colchicine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/003/001", "product_name": "Hydrocortisone 10 mg Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2017-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/003/002", "product_name": "Hydrocortisone 20 mg Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2017-10-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB", "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/003/003", "product_name": "Hydrocortisone 5 mg Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2024-02-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/004/001", "product_name": "Clindamycin 75 mg Capsules, hard", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FF01" ], "active_substances": [ "Clindamycin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/004/002", "product_name": "Clindamycin 150 mg Capsules, hard", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FF01" ], "active_substances": [ "Clindamycin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/004/003", "product_name": "Clindamycin 300 mg Capsules, hard", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2019-04-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FF01" ], "active_substances": [ "Clindamycin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BB01" ], "active_substances": [ "Carbimazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/006/002", "product_name": "Carbimazole 20 mg Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2022-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BB01" ], "active_substances": [ "Carbimazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/007/001", "product_name": "Fludrocortisone Acetate Renata 0.1 mg tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2023-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AA02" ], "active_substances": [ "Fludrocortisone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/008/001", "product_name": "Naratriptan 2.5 mg film-coated tablet", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2024-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC02" ], "active_substances": [ "Naratriptan 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(Ireland) Limited", "authorised_date": "2023-11-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/010/001", "product_name": "Rivaroxaban 10 mg film-coated tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/011/001", "product_name": "Cabergoline 1 mg Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC06" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/011/002", "product_name": "Cabergoline 2 mg Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BC06" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/012/001", "product_name": "Tadalafil 5 mg film-coated tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/012/002", "product_name": "Tadalafil 20 mg film-coated tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2025-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/014/001", "product_name": "Cabergoline 500 micrograms Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2024-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G02CB03" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/016/001", "product_name": "Levonorgestrel/ Ethinylestradiol 150 micrograms/30 micrograms coated tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2026-08-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03AA07" ], "active_substances": [ "Levonorgestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/017/001", "product_name": "Levothyroxine Sodium 25 microgram tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2026-08-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/017/003", "product_name": "Levothyroxine Sodium 75 microgram tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2026-08-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/017/004", "product_name": "Levothyroxine Sodium 100 microgram tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2026-08-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/018/001", "product_name": "Opsaren 10 mg Film-coated Tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2026-02-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22865/021/001", "product_name": "Prednisolone Renata 5 mg tablets", "holder": "Renata Pharmaceuticals (Ireland) Limited", "authorised_date": "2026-08-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB06" ], "active_substances": [ "Prednisolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22869/001/001", "product_name": "Dolocopin 40mg/g Cream", "holder": "Ferndale Laboratories Limited", "authorised_date": "2015-11-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2287/001/001", "product_name": "ChloraPrep with Tint 2% w/v/70% v/v cutaneous solution", "holder": "Becton Dickinson France", "authorised_date": "2010-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AC", "D08AC52" ], "active_substances": [ "Chlorhexidine gluconate", "Isopropyl alcohol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2287/001/002", "product_name": "ChloraPrep 2% w/v/ 70% v/v cutaneous solution", "holder": "Becton Dickinson France", "authorised_date": "2012-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AC", "D08AC52" ], "active_substances": [ "Chlorhexidine gluconate", "Isopropyl alcohol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2287/001/003", "product_name": "ChloraPrep 2% w/v/70% v/v impregnated cutaneous swab", "holder": "Becton Dickinson France", "authorised_date": "2022-02-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Impregnated cutaneous swab", "atc_codes": [ "D08AC52" ], "active_substances": [ "Chlorhexidine digluconate", "Isopropyl alcohol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/001/001", "product_name": "Azuzote 30 mg film-coated tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2020-01-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BG06" ], "active_substances": [ "Nefopam hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/004/002", "product_name": "Fexofenadine Hydrochloride 120 mg Film-coated tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/004/003", "product_name": "Fexofenadine Hydrochloride 180 mg Film-coated tablets", "holder": "Azure 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"Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/010/003", "product_name": "Carbamazepine 400 mg Tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2020-10-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AF01" ], "active_substances": [ "Carbamazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/013/001", "product_name": "Dosulepin Hydrochloride 25 mg Hard Capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AA16" ], "active_substances": [ 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"2024-10-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03CA04" ], "active_substances": [ "Torasemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/015/001", "product_name": "Trazodone Hydrochloride 150 mg Film-Coated Tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2020-07-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"Azure Pharmaceuticals Ltd.", "authorised_date": "2022-01-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA01" ], "active_substances": [ "Betahistine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/018/001", "product_name": "Trazodone Hydrochloride Azure 50 mg hard capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/018/002", "product_name": "Trazodone Hydrochloride Azure 100 mg hard capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/020/001", "product_name": "Co-codamol 15 mg/500 mg film-coated tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Marketed", 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"dosage_form": "Film-coated tablet", "atc_codes": [ "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/027/001", "product_name": "Clopidogrel Azure 75 mg film-coated tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC04" ], "active_substances": [ "Clopidogrel Hydrogen Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/030/001", "product_name": "Micrazym 10000 units gastro-resistant capsules, hard", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/030/002", "product_name": "Micrazym 25000 units gastro-resistant capsules, hard", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2025-01-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/031/001", "product_name": "Propranolol Azure 10 mg film-coated tablets", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2023-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AA05" ], "active_substances": [ "Propranolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/031/002", "product_name": "Propranolol Azure 40 mg 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"Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/034/001", "product_name": "Atomoxetine Azure 10 mg hard capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/034/002", "product_name": "Atomoxetine Azure 18 mg hard capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/034/003", "product_name": "Atomoxetine Azure 25 mg hard capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"product_name": "Atomoxetine Azure 100 mg hard capsules", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-05-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/035/001", "product_name": "Budesonide Azure 0.5 mg/2 ml Nebuliser Suspension", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/035/002", "product_name": "Budesonide Azure 1 mg/2 ml Nebuliser Suspension", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser suspension", "atc_codes": [ "R03BA02" ], "active_substances": [ "Budesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22871/037/001", "product_name": "Progesterone 25 mg solution for injection", "holder": "Azure Pharmaceuticals Ltd.", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22874/001/001", "product_name": "Sodium Nitrite Hope Pharmaceuticals 30 mg/mL Solution for Injection", "holder": "Hope Pharmaceuticals Ltd", "authorised_date": "2019-02-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB08" ], "active_substances": [ "SODIUM NITRITE" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB", "V03AB06", "V03AB08" ], "active_substances": [ "SODIUM NITRITE", "Sodium thiosulfate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22879/001/002", "product_name": "Sevelamer Hydrochloride Waymade 800 mg film-coated tablets", "holder": "Waymade B.V.", "authorised_date": "2020-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE", "V03AE02" ], "active_substances": [ "Sevelamer hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03BA", "H03BA02" ], "active_substances": [ "Propylthiouracil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22902/002/001", "product_name": "Colchicine Halewood 500 microgram Tablets", "holder": "Halewood Chemicals (Ireland) Limited", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AC01" ], "active_substances": [ "Colchicine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22914/001/001", "product_name": "Cefixime Nectar Lifesciences 100 mg/5 ml Powder for Oral Suspension", "holder": "NECLIFE PT UNIPESSOAL LDA", "authorised_date": "2018-11-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01DA08" ], "active_substances": [ "Cefixime" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22919/001/001", "product_name": "After Bite 3.5% w/v Cutaneous Emulsion", "holder": "Zenview Limited", "authorised_date": "1991-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous emulsion", "atc_codes": [], "active_substances": [ "Ammonia" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA22937/001/001", "product_name": "Ghemaxan 2,000 IU (20 mg)/0.2 mL solution for injection in pre-filled syringes", "holder": "Chemi S.p.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Extracorporeal use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA22937/001/002", "product_name": "Ghemaxan 4,000 IU (40 mg)/0.4 mL solution for injection in pre-filled syringes", "holder": "Chemi S.p.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Extracorporeal use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA22937/001/003", "product_name": "Ghemaxan 6,000 IU (60 mg)/0.6 mL solution for injection in pre-filled syringes", "holder": "Chemi S.p.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Extracorporeal use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA22937/001/004", "product_name": "Ghemaxan 8,000 IU (80 mg)/0.8 mL solution for injection in pre-filled syringes", "holder": "Chemi S.p.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Extracorporeal use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply 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"Chemi S.p.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Extracorporeal use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA22937/001/007", "product_name": "Ghemaxan 15,000 IU (150 mg)/1 mL solution for injection in pre-filled syringes", "holder": "Chemi S.p.A.", "authorised_date": "2020-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Extracorporeal use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA22939/001/001", "product_name": "Amikacin Caragen 250 mg/ml solution for injection/infusion", "holder": "Caragen Limited", "authorised_date": "2021-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01GB06" ], "active_substances": [ "Amikacin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2294/001/001", "product_name": "Paracetamol 1000 mg, Phenylephrine hydrochloride 12.2 mg, Powder for oral solution, Lemon flavour", "holder": "WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH", "authorised_date": "2011-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Phenylephrine hydrochloride", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2294/002/001", "product_name": "Paracetamol 500 mg, Guaifenesin 200 mg, Phenylephrine Hydrochloride 10 mg, Powder for Oral Solution", "holder": "WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Guaifenesin", "Phenylephrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2294/003/001", "product_name": "Vicks Vaporub Inhalation Vapour, Ointment Levomenthol 2.75% w/wCamphor 5.00% w/wEucalyptus Oil 1.50% w/w Turpentine Oil 5.00% w/w", "holder": "WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH", "authorised_date": "2000-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, ointment", "atc_codes": [ "R05X" ], "active_substances": [ "Levomenthol", "Camphor", "Eucalyptus oil", "Turpentine oil" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2294/004/001", "product_name": "Vicks Sinex Micromist 0.05% w/v Nasal Spray, Solution", "holder": "WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AA", "R01AA05" ], "active_substances": [ "Oxymetazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2294/005/001", "product_name": "Vicks Inhaler Nasal Stick Menthol 125 mg Camphor 50 mg Siberian Pine Needle Oil 10 mg", "holder": "WICK Pharma - Zweigniederlassung der Procter & Gamble GmbH", "authorised_date": "1988-11-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal stick", "atc_codes": [ "R01AX", "R01AX10" ], "active_substances": [ "Camphor", "Menthol", "Siberian Pine Needle Oil" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22946/001/001", "product_name": "Mifegyne 200 mg tablets", "holder": "EXELGYN", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03XB01" ], "active_substances": [ "Mifepristone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22946/001/002", "product_name": "Mifegyne 600 mg tablets", "holder": "EXELGYN", "authorised_date": "2018-11-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03XB01" ], "active_substances": [ "Mifepristone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22946/002/001", "product_name": "MisoOne 400 microgram tablets", "holder": "EXELGYN", "authorised_date": "2019-11-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02AD06" ], "active_substances": [ "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22981/001/001", "product_name": "Colecalciferol EQL Pharma 800 IU tablet", "holder": "EQL Pharma AB", "authorised_date": "2021-07-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA22981/001/002", "product_name": "Colecalciferol EQL Pharma 2000 IU tablet", "holder": "EQL Pharma AB", "authorised_date": "2021-07-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/001/001", "product_name": "Potassium Chloride 0.3% w/v and Sodium Chloride 0.18% w/v in Glucose 4% w/v Intravenous Infusion BP (Viaflo Container)", "holder": "Baxter Holding B.V.", "authorised_date": "2008-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Potassium chloride", "Sodium chloride", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/001/002", "product_name": "Potassium Chloride 0.15% w/v, Sodium Chloride 0.18% w/v, Glucose 4% w/v Solution for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2011-06-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Potassium chloride", "Sodium chloride", "Glucose anhydrous" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/002/001", "product_name": "Sodium Chloride 0.9% w/v Intravenous Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2003-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/002/002", "product_name": "Sodium Chloride 0.45% w/v Solution for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/002/003", "product_name": "Sodium Chloride Intravenous Infusion BP 0.9% w/v (viaflex container)", "holder": "Baxter Holding B.V.", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/003/001", "product_name": "Glucose 5% w/v Intravenous Infusion BP, polyolefin/polyamide bag", "holder": "Baxter Holding B.V.", "authorised_date": "2003-05-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/003/002", "product_name": "Glucose 10% w/v Solution for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-06-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA03" ], "active_substances": [ "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/004/001", "product_name": "Chlorhexidine Acetate BP 0.05% w/v Irrigation solution", "holder": "Baxter Holding B.V.", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Irrigation solution", "atc_codes": [ "B05CA", "B05CA02" ], "active_substances": [ "Chlorhexidine acetate" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/005/001", "product_name": "Chlorhexidine acetate 0.015% w/v and Cetrimide 0.15% w/v Irrigation solution", "holder": "Baxter Holding B.V.", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Irrigation solution", "atc_codes": [ "D08AC", "D08AC52" ], "active_substances": [ "Chlorhexidine acetate", "Cetrimide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/006/001", "product_name": "Mannitol 10% Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2007-09-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BC", "B05BC01" ], "active_substances": [ "Mannitol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/006/002", "product_name": "Mannitol 15% w/v solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BC", "B05BC01" ], "active_substances": [ "Mannitol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/007/001", "product_name": "Plasma-Lyte 148 & Glucose 5% w/v solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2007-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Potassium chloride", "Magnesium chloride hexahydrate", "Sodium acetate trihydrate", "Sodium gluconate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/008/001", "product_name": "Sodium Chloride 0.45% w/v and Glucose 5.0% w/v Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2013-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB02" ], "active_substances": [ "Sodium chloride", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/008/002", "product_name": "Sodium Chloride 0.9% w/v and Glucose 5% w/v Solution for Infusion BP (Viaflo container)", "holder": "Baxter Holding B.V.", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05CB", "B05CB01" ], "active_substances": [ "Sodium chloride", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/008/003", "product_name": "Sodium Chloride 0.45% w/v and Glucose 2.5% w/v Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2004-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05CB", "B05CB01" ], "active_substances": [ "Sodium chloride", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/008/004", "product_name": "Sodium Chloride 0.3% w/v and Glucose 3.3% w/v Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2004-06-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05CB", "B05CB01" ], "active_substances": [ "Sodium chloride", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/008/005", "product_name": "Sodium Chloride 0.18% w/v and Glucose 4.0% w/v Intravenous Infusion BP, (Viaflo Container)", "holder": "Baxter Holding B.V.", "authorised_date": "2007-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA31" ], "active_substances": [ "Sodium chloride", "Anhydrous glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/009/001", "product_name": "Potassium Chloride 0.3 % w/v and Glucose 5% w/v Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2003-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB02" ], "active_substances": [ "Potassium chloride", "Glucose (as monohydrate)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/009/002", "product_name": "Potassium Chloride 0.15% w/v and Glucose 5% w/v Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2003-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA", "B05XA01" ], "active_substances": [ "Potassium chloride", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/010/001", "product_name": "Potassium Chloride 0.3% w/v & Sodium Chloride 0.9% w/v Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2003-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA01" ], "active_substances": [ "Potassium chloride", "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/010/002", "product_name": "Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Solution for Infusion - BP", "holder": "Baxter Holding B.V.", "authorised_date": "2007-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Potassium chloride", "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/011/001", "product_name": "Ringer’s Solution for Infusion, Viaflo container", "holder": "Baxter Holding B.V.", "authorised_date": "2003-07-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/012/001", "product_name": "Compound Sodium Lactate Solution for Infusion BP", "holder": "Baxter Holding B.V.", "authorised_date": "2003-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Calcium chloride dihydrate", "Sodium lactate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/013/001", "product_name": "Water for Injections Ph. Eur., viaflo container", "holder": "Baxter Holding B.V.", "authorised_date": "2002-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solvent for parenteral use", "atc_codes": [ "V07AB" ], "active_substances": [ "Water for injection" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/014/001", "product_name": "Heparin Sodium BP 1000 IU/l in 0.9% w/v Sodium Chloride IV Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1984-06-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AB", "B01AB01" ], "active_substances": [ "Heparin sodium", "Sodium chloride", "Disodium phosphate dodecahydrate", "Citric acid monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/014/002", "product_name": "Heparin Sodium BP 2000 IU/l in 0.9 % w/v Sodium Chloride IV infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1984-06-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AB", "B01AB01" ], "active_substances": [ "Citric acid monohydrate", "Disodium phosphate dodecahydrate", "Sodium chloride", "Heparin sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/018/001", "product_name": "Primene 10% Solution for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1995-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "L-isoleucine", "L-leucine", "L-valine", "L-lysine", "L-methionine", "L-threonine", "L-tryptophan", "L-arginine", "L-histidine", "L-alanine", "L-aspartic acid", "Cysteine", "L-glutamic acid", "Glycine", "L-proline", "L-serine", "L-tyrosine", "Ornithine hydrochloride", "Taurine", "L-phenylalanine" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/019/001", "product_name": "Cernevit, Powder for Solution for Injection or Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1993-01-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "A11BA" ], "active_substances": [ "Retinol palmitate", "Cholecalciferol", "Dl-a-tocopherol", "Ascorbic acid", "Cocarboxylase tetrahydrate", "Riboflavin sodium phosphate", "Pyridoxine hydrochloride", "Cyanocobalamin", "Folic acid", "Dexpanthenol", "D-biotin", "Nicotinamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/020/001", "product_name": "CLINIMIX N14G30E, solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1996-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "L-leucine", "L-phenylalanine", "L-methionine", "L-isoleucine", "L-valine", "L-histidine", "L-threonine", "L-tryptophan", "L-alanine", "L-arginine", "Glycine", "L-proline", "L-serine", "L-tyrosine", "Sodium acetate trihydrate", "Dibasic potassium phosphate", "Sodium chloride", "Magnesium chloride hexahydrate", "Calcium chloride dihydrate", "L-lysine hydrochloride", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/021/001", "product_name": "Brevibloc Premixed 10 mg/ml Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2010-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C07AB", "C07AB09" ], "active_substances": [ "Esmolol Hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/021/002", "product_name": "Brevibloc Premixed 10 mg/ml solution for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "C07AB", "C07AB09" ], "active_substances": [ "Esmolol Hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/023/001", "product_name": "Suprane Inhalation vapour, solution", "holder": "Baxter Holding B.V.", "authorised_date": "1999-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, solution", "atc_codes": [ "N01AB", "N01AB07" ], "active_substances": [ "Desflurane" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/024/001", "product_name": "Uromitexan 100mg/ml Solution for Injection or Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "1996-09-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "V03AF", "V03AF01" ], "active_substances": [ "Mesna" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/024/002", "product_name": "Uromitexan tablets 400 mg", "holder": "Baxter Holding B.V.", "authorised_date": "1996-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AF", "V03AF01" ], "active_substances": [ "Mesna" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/024/003", "product_name": "Uromitexan Tablets 600mg", "holder": "Baxter Holding B.V.", "authorised_date": "1996-04-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AF", "V03AF01" ], "active_substances": [ "Mesna" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/025/001", "product_name": "TISSEEL Ready to use Solutions for Sealant", "holder": "Baxter Holding B.V.", "authorised_date": "2010-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for sealant", "atc_codes": [ "B02BC", "V03AK" ], "active_substances": [ "Human fibrinogen", "Aprotinin", "Human factor xiii", "Human thrombin", "Calcium chloride" ], "routes": [ "Epilesional use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/025/002", "product_name": "TISSEEL Lyo Powder and Solvent for Sealant", "holder": "Baxter Holding B.V.", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for sealant", "atc_codes": [ "B02BC", "V03AK" ], "active_substances": [ "Human fibrinogen", "Aprotinin", "Human thrombin", "Human factor xiii", "Calcium chloride" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/026/001", "product_name": "ARTISS Solutions for Sealant, deep frozen", "holder": "Baxter Holding B.V.", "authorised_date": "2009-07-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for sealant", "atc_codes": [ "B02BC", "V03AK" ], "active_substances": [ "Human fibrinogen", "Human thrombin", "Calcium chloride", "Aprotinin" ], "routes": [ "Epilesional use", "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/027/001", "product_name": "Endoxana Injection 500 mg Powder for Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2008-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01AA", "L01AA01" ], "active_substances": [ "Cyclophosphamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/027/002", "product_name": "Endoxana Injection 1000 mg Powder for Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2008-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01AA", "L01AA01" ], "active_substances": [ "Cyclophosphamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/027/003", "product_name": "Endoxana Coated Tablets 50 mg", "holder": "Baxter Holding B.V.", "authorised_date": "2008-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "L01AA", "L01AA01" ], "active_substances": [ "Cyclophosphamide monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/028/001", "product_name": "Mitoxana 1 g Powder for Sterile Concentrate", "holder": "Baxter Holding B.V.", "authorised_date": "2008-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA06" ], "active_substances": [ "Ifosfamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/028/002", "product_name": "Mitoxana 2 g powder for sterile concentrate", "holder": "Baxter Holding B.V.", "authorised_date": "2008-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA06" ], "active_substances": [ "Ifosfamide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/029/001", "product_name": "Triomel Peripheral 4 g/L nitrogen 700 kcal/L with electrolytes emulsion for 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"product_name": "Triomel 5g/L nitrogen 990kcal/L with electrolytes, emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Refined olive oil + refined soybean oil", "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine acetate", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium acetate trihydrate", "Sodium glycerophosphate, hydrated", "Potassium chloride", "Magnesium chloride hexahydrate", "Calcium chloride dihydrate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/029/003", "product_name": "Triomel 7g/L nitrogen 1140kcal/L with electrolytes emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Refined olive oil + refined soybean oil", "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium glycerophosphate, hydrated", "Potassium chloride", "Magnesium chloride hexahydrate", "Calcium chloride dihydrate", "Lysine acetate", "Glucose monohydrate", "Sodium acetate trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/029/004", "product_name": "Triomel 7g/L nitrogen 1140kcal/L emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Refined olive oil + refined soybean oil", "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Lysine acetate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/029/005", "product_name": "Triomel 9g/L nitrogen 1070kcal/L with electrolytes emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Refined olive oil + refined soybean oil", "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium acetate trihydrate", "Sodium glycerophosphate, hydrated", "Potassium chloride", "Magnesium chloride hexahydrate", "Calcium chloride dihydrate", "Lysine acetate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/029/006", "product_name": "Triomel 9g/L nitrogen 1070kcal/L emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2010-04-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Refined olive oil + refined soybean oil", "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Lysine acetate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/030/001", "product_name": "Numeta G16%E emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2011-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Cysteine", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine monohydrate", "Methionine", "Ornithine hydrochloride", "Phenylalanine", "Proline", "Serine", "Taurine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium chloride", "Potassium acetate", "Calcium chloride dihydrate", "Magnesium acetate tetrahydrate", "Sodium glycerophosphate, hydrated", "Glucose monohydrate", "Refined olive oil + refined soybean oil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/030/002", "product_name": "Numeta G19%E emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2011-12-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Methionine", "Ornithine hydrochloride", "Phenylalanine", "Proline", "Serine", "Taurine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium chloride", "Potassium acetate", "Calcium chloride dihydrate", "Magnesium acetate tetrahydrate", "Sodium glycerophosphate, hydrated", "Alanine", "Arginine", "Aspartic Acid", "Cysteine", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Refined olive oil + refined soybean oil", "Lysine monohydrate", "Glucose monohydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/030/003", "product_name": "Numeta G13%E Preterm emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2016-05-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Cysteine", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine monohydrate", "Methionine", "Ornithine hydrochloride", "Phenylalanine", "Proline", "Serine", "Taurine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Potassium acetate", "Calcium chloride dihydrate", "Magnesium acetate tetrahydrate", "Sodium glycerophosphate, hydrated", "Glucose monohydrate", "Refined olive oil + refined soybean oil" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/031/001", "product_name": "Sevoflurane Baxter, 100%, inhalation vapour, liquid", "holder": "Baxter Holding B.V.", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, liquid", "atc_codes": [ "N01AB", "N01AB08" ], "active_substances": [ "Sevoflurane" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/032/001", "product_name": "Plasma-Lyte 148 (pH 7.4) solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2017-07-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB", "B05BB01" ], "active_substances": [ "Sodium chloride", "Potassium chloride", "Magnesium chloride hexahydrate", "Sodium acetate trihydrate", "Sodium gluconate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/033/001", "product_name": "Fluconazole 2 mg/ml solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2008-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "J02AC", "J02AC01" ], "active_substances": [ "Fluconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/035/001", "product_name": "Bupivacaine 2.5 mg/ml Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2010-09-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Bupivacaine hydrochloride, monohydrate" ], "routes": [ "Epidural use", "Intraarticular use", "Perineural use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/035/002", "product_name": "Bupivacaine 5 mg/ml Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2010-09-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB10" ], "active_substances": [ "Bupivacaine hydrochloride, monohydrate" ], "routes": [ "Epidural use", "Intraarticular use", "Perineural use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/036/001", "product_name": "Furosemide 10 mg/ml Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2009-04-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/037/001", "product_name": "Ondansetron 2mg/ml Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2009-11-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/038/001", "product_name": "Propofol 10 mg/ml Emulsion for injection/infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2011-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/038/002", "product_name": "Propofol 20 mg/ml Emulsion for injection/infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2011-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection/infusion", "atc_codes": [ "N01AX", "N01AX10" ], "active_substances": [ "Propofol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/041/001", "product_name": "Aciclovir 25mg/ml Concentrate for solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2013-03-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/043/007", "product_name": "TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine acetate", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Magnesium chloride hexahydrate", "Potassium chloride", "Sodium acetate trihydrate", "Sodium glycerophophate hydrate", "Glucose monohydrate", "Calcium chloride dihydrate", "Olive oil, refined", "Soya Bean Oil, Refined Ph.Eur" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/043/008", "product_name": "TRIOMEL 12 g/l nitrogen 950 kcal/l, emulsion for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2019-09-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA10" ], "active_substances": [ "Alanine", "Arginine", "Aspartic Acid", "Glutamic acid", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine acetate", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Glucose monohydrate", "Olive oil, refined", "Soya Bean Oil, Refined Ph.Eur" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/044/001", "product_name": "Finomel Peri Emulsion for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Alanine", "Arginine", "Glycine", "Histidine", "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium acetate trihydrate", "Potassium chloride", "Calcium chloride dihydrate", "Magnesium sulphate heptahydrate", "Sodium Glycerophosphate Hydrate", "Zinc sulphate heptahydrate", "Glucose monohydrate", "Soya Bean Oil, Refined Ph.Eur", "Olive oil, refined", "Medium chain triglycerides saturated", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/044/002", "product_name": "Finomel Emulsion for Infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Emulsion for infusion", "atc_codes": [ "B05BA", "B05BA01" ], "active_substances": [ "Glycine", "Alanine", "Arginine", "Histidine", "Isoleucine", "Leucine", "Lysine hydrochloride", "Methionine", "Phenylalanine", "Proline", "Serine", "Threonine", "Tryptophan", "Tyrosine", "Valine", "Sodium acetate trihydrate", "Potassium chloride", "Calcium chloride dihydrate", "Magnesium sulphate heptahydrate", "Sodium Glycerophosphate Hydrate", "Zinc sulphate heptahydrate", "Glucose monohydrate", "Soya Bean Oil, Refined Ph.Eur", "Olive oil, refined", "Medium chain triglycerides saturated", "Fish oil, rich in omega-3 acids" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/045/001", "product_name": "Maintelyte solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2019-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05BB02" ], "active_substances": [ "Sodium chloride", "GLUCOSE MONOHYDRATE PH. EUR.", "Sodium acetate, trihydrate", "POTASSIUM CHLORIDE PH. EUR.", "MAGNESIUM CHLORIDE HEXAHYDRATE PH. EUR." ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/048/001", "product_name": "Tranexamic acid 100 mg/mL solution for injection/infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2020-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B02AA02" ], "active_substances": [ "TRANEXAMIC ACID PH. EUR." ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/050/001", "product_name": "Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion", "holder": "Baxter Holding B.V.", "authorised_date": "2021-03-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "N05CM18" ], "active_substances": [ "Dexmedetomidine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2299/058/001", "product_name": "Sugammadex 100 mg/ml Solution for Injection", "holder": "Baxter Holding B.V.", "authorised_date": "2023-07-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/001/001", "product_name": "Ofost 5 IU/ml concentrate for solution for infusion or solution for intramuscular injection", "holder": "AS Grindeks", "authorised_date": "2020-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01BB02" ], "active_substances": [ "Oxytocin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/001/002", "product_name": "Ofost 10 IU/ml concentrate for solution for infusion or solution for intramuscular injection", "holder": "AS Grindeks", "authorised_date": "2020-12-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "H01BB02" ], "active_substances": [ "Oxytocin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/002/001", "product_name": "Ursogrix 250 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-02-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/003/001", "product_name": "Memantine Grindeks 10 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2021-03-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/001", "product_name": "Lenalidomide Grindeks 2.5 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/002", "product_name": "Lenalidomide Grindeks 5 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/003", "product_name": "Lenalidomide Grindeks 7.5 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/004", "product_name": "Lenalidomide Grindeks 10 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/005", "product_name": "Lenalidomide Grindeks 15 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/006", "product_name": "Lenalidomide Grindeks 20 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/004/007", "product_name": "Lenalidomide Grindeks 25 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2021-12-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX04" ], "active_substances": [ "Lenalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/006/001", "product_name": "Sitagliptin/Metformin hydrochloride Grindeks 50 mg/850 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Metformin Hydrochloride", "Sitagliptin Hydrochloride Monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/006/002", "product_name": "Sitagliptin/Metformin hydrochloride Grindeks 50 mg/1000 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin Hydrochloride Monohydrate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/007/001", "product_name": "Escitalopram Grindeks 5 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/007/002", "product_name": "Escitalopram Grindeks 10 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/007/003", "product_name": "Escitalopram Grindeks 20 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram oxalate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/008/001", "product_name": "Rivaroxaban Grindeks 10 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-07-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/008/002", "product_name": "Rivaroxaban Grindeks 15 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-07-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/008/003", "product_name": "Rivaroxaban Grindeks 20 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-07-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/018/001", "product_name": "Lisinopril Grindeks 5 mg tablets", "holder": "AS Grindeks", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/018/002", "product_name": "Lisinopril Grindeks 10 mg tablets", "holder": "AS Grindeks", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/018/003", "product_name": "Lisinopril Grindeks 20 mg tablets", "holder": "AS Grindeks", "authorised_date": "2023-05-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/020/001", "product_name": "Apixaban Grindeks 2.5 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-09-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/020/002", "product_name": "Apixaban Grindeks 5 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-09-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/021/001", "product_name": "Risperidone Grindeks 0.5 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/021/002", "product_name": "Risperidone Grindeks 1 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/021/003", "product_name": "Risperidone Grindeks 2 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/021/004", "product_name": "Risperidone Grindeks 3 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/021/005", "product_name": "Risperidone Grindeks 4 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/021/006", "product_name": "Risperidone Grindeks 6 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/022/001", "product_name": "Pomalidomide Grindeks 1 mg hard capsule", "holder": "AS Grindeks", "authorised_date": "2024-11-01", "product_type": "HM", "market_status": "Not 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"PA22992/022/003", "product_name": "Pomalidomide Grindeks 3 mg hard capsule", "holder": "AS Grindeks", "authorised_date": "2024-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/022/004", "product_name": "Pomalidomide Grindeks 4 mg hard capsule", "holder": "AS Grindeks", "authorised_date": "2024-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AX06" ], "active_substances": [ "Pomalidomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/024/001", "product_name": "Mirtazapine Grindeks 15 mg orodispersible tablets", "holder": "AS Grindeks", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/024/002", "product_name": "Mirtazapine Grindeks 30 mg orodispersible tablets", "holder": "AS Grindeks", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/024/003", "product_name": "Mirtazapine Grindeks 45 mg orodispersible tablets", "holder": "AS Grindeks", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/025/001", "product_name": "Mildronate 500 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C01EB22" ], "active_substances": [ "Meldonium dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/026/001", "product_name": "Lacosamide Grindeks 50 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/026/002", "product_name": "Lacosamide Grindeks 100 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/026/003", "product_name": "Lacosamide Grindeks 150 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/026/004", "product_name": "Lacosamide Grindeks 200 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/027/001", "product_name": "Loperamide Grindeks 2 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/028/001", "product_name": "Alprazolam Grindeks 250 microgram tablets", "holder": "AS Grindeks", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/028/002", "product_name": "Alprazolam Grindeks 500 microgram tablets", "holder": "AS Grindeks", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/028/003", "product_name": "Alprazolam Grindeks 1 mg tablets", "holder": "AS Grindeks", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/001", "product_name": "Pregabalin Grindeks 25 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/002", "product_name": "Pregabalin Grindeks 50 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/003", "product_name": "Pregabalin Grindeks 75 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/004", "product_name": "Pregabalin Grindeks 100 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/005", "product_name": "Pregabalin Grindeks 150 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/006", "product_name": "Pregabalin Grindeks 200 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/029/007", "product_name": "Pregabalin Grindeks 300 mg hard capsules", "holder": "AS Grindeks", "authorised_date": "2026-04-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF02" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/030/001", "product_name": "Zopiclone Grindeks 3.75 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/030/002", "product_name": "Zopiclone Grindeks 5 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/030/003", "product_name": "Zopiclone Grindeks 7.5 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2024-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/038/001", "product_name": "Alsemora 10 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22992/038/002", "product_name": "Alsemora 20 mg film-coated tablets", "holder": "AS Grindeks", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DX01" ], "active_substances": [ "Memantine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "*** AWAITING VALUE ***" ], "supply_status": "", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/001/001", "product_name": "Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2021-12-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "R06AA59" ], "active_substances": [ "Pyridoxine hydrochloride", "Doxylamine hydrogen succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/002/001", "product_name": "Slyndy 4 mg film-coated tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2021-07-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "QG03AC10" ], "active_substances": [ "Drospirenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/003/001", "product_name": "Xonvea MR 20 mg/20 mg modified-release tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "R06AA59" ], "active_substances": [ "Doxylamine hydrogen succinate", "Pyridoxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/004/001", "product_name": "Doxpirexel 20 mg/ 20 mg modified-release tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "R06AA59" ], "active_substances": [ "Pyridoxine hydrochloride", "Doxylamine hydrogen succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/005/001", "product_name": "Doxylamine/Pyridoxine Exeltis Healthcare 20mg/ 20mg modified-release tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "R06AA59" ], "active_substances": [ "Doxylamine hydrogen succinate", "Pyridoxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/006/001", "product_name": "Xonvea 10 mg/10 mg gastro-resistant tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2019-04-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "R06AA59" ], "active_substances": [ "Pyridoxine hydrochloride", "DOXYLAMINE SUCCINATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA22998/007/001", "product_name": "Kelzy 2 mg/0.02 mg prolonged release tablets", "holder": "Exeltis Healthcare S.L.", "authorised_date": "2024-07-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G03AA16" ], "active_substances": [ "Dienogest", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23005/001/001", "product_name": "Metopirone 250 mg soft capsules", "holder": "Esteve Pharmaceuticals S.A.", "authorised_date": "2012-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "V04CD", "V04CD01" ], "active_substances": [ "Metyrapone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/001/001", "product_name": "Peiotal 25 microgram/50 microgram/dose pressurised inhalation, suspension", "holder": "Genetic S.p.A.", "authorised_date": "2022-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/001/002", "product_name": "Peiotal 25 microgram/125 microgram/dose pressurised inhalation, suspension", "holder": "Genetic S.p.A.", "authorised_date": "2022-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/001/003", "product_name": "Peiotal 25 microgram/250 microgram/dose pressurised inhalation, suspension", "holder": "Genetic S.p.A.", "authorised_date": "2022-01-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/002/001", "product_name": "Beclometasone/formoterol 100 micrograms /6 micrograms per actuation pressurised inhalation, solution", "holder": "Genetic S.p.A.", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03AK08" ], "active_substances": [ "Beclometasone 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Directive No 2001/83/EC)" }, { "licence_number": "PA23010/004/001", "product_name": "Salmeterol/Fluticasone 50 microgram/100 microgram/dose inhalation powder, pre-dispensed", "holder": "Genetic S.p.A.", "authorised_date": "2024-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/004/002", "product_name": "Salmeterol/Fluticasone 50 microgram/250 microgram/dose inhalation powder, pre-dispensed", "holder": "Genetic S.p.A.", "authorised_date": "2024-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/004/003", "product_name": "Salmeterol/Fluticasone 50 microgram/500 microgram/dose inhalation powder, pre-dispensed", "holder": "Genetic S.p.A.", "authorised_date": "2024-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23010/007/001", "product_name": "Latanoprost 50 microgram/ml eye drops, solution in single-dose container", "holder": "Genetic S.p.A.", "authorised_date": "2026-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23029/001/001", "product_name": "Dienogest Stragen 2 mg film-coated tablets", "holder": "G&G Pharmaceutical (Netherlands) B.V.", "authorised_date": "2019-06-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03DB", "G03DB08" ], "active_substances": [ "Dienogest" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23030/001/001", "product_name": "Bronx Airmaster 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed", "holder": "Neutec Inhaler Ireland Limited", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23030/001/002", "product_name": "Bronx Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed", "holder": "Neutec Inhaler Ireland Limited", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23030/001/003", "product_name": "Bronx Airmaster 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed", "holder": "Neutec Inhaler Ireland Limited", "authorised_date": "2020-04-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23030/002/001", "product_name": "Salbutamol Neutec 2.5 mg/2.5 ml nebuliser solution", "holder": "Neutec Inhaler Ireland Limited", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AC02" ], "active_substances": [ "SALBUTAMOL SULFATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23030/003/001", "product_name": "Ipratropium bromide/Salbutamol Neutec 0.5 mg/2.5 mg per 2.5 ml nebuliser solution", "holder": "Neutec Inhaler Ireland Limited", "authorised_date": "2023-09-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R03AL02" ], "active_substances": [ "Ipratropium bromide monohydrate", "SALBUTAMOL SULFATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23039/001/001", "product_name": "Lithium Chloride 0.15 mmol/ml. Solution for Injection", "holder": "LiDCO Netherlands B.V.", "authorised_date": "2005-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05AN", "N05AN01" ], "active_substances": [ "Lithium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23067/001/001", "product_name": "PREGABALIN BASICS 20 mg/ml oral solution", "holder": "Basics GmbH", "authorised_date": "2022-01-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AX16" ], "active_substances": [ "Pregabalin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2307/004/001", "product_name": "Madopar 200 mg/50 mg hard capsules", "holder": "Roche Products (Ireland) Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Benserazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2307/004/002", "product_name": "Madopar 50 mg/12.5 mg dispersible tablets", "holder": "Roche Products (Ireland) Limited", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Benserazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2307/004/003", "product_name": "Madopar 100 mg/25 mg dispersible tablets", "holder": "Roche Products (Ireland) Limited", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Benserazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2307/005/001", "product_name": "Pulmozyme 2500 U/ 2.5ml, nebuliser solution", "holder": "Roche Products (Ireland) Limited", "authorised_date": "1994-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R05CB", "R05CB13" ], "active_substances": [ "Dornase alfa" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2307/008/002", "product_name": "Rocephin 1 g powder and solvent for IM injection only", "holder": "Roche Products (Ireland) Limited", "authorised_date": "2005-05-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "J01DD04" ], "active_substances": [ "Ceftriaxone sodium", "Lidocaine Hydrochloride Monohydrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2307/008/003", "product_name": "Rocephin 1 g powder for solution for injection/infusion", "holder": "Roche Products (Ireland) Limited", "authorised_date": "2021-06-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2308/001/001", "product_name": "Voltfast Sachets 50mg Powder for Oral Solution", "holder": "Wisdom Pharmaceutical Technology Co Limited", "authorised_date": "2006-07-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "M01AB", "M01AB05" ], "active_substances": [ "Diclofenac potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/006/001", "product_name": "Dexsol 2 mg/ 5 ml Oral Solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2006-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/007/001", "product_name": "Dexamethasone 10 mg/5ml Oral Solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2013-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "H02AB", "H02AB02" ], "active_substances": [ "Dexamethasone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/008/001", "product_name": "Metformin Hydrochloride 500 mg/5 ml Oral Solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2007-10-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A10BA", "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/009/001", "product_name": "Clonazepam Rosemont 0.5 mg/5 ml oral solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N03AE", "N03AE01" ], "active_substances": [ "Clonazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/010/001", "product_name": "Gabapentin Rosemont 50 mg/ml Oral Solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2012-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/011/001", "product_name": "Methadone Hydrochloride Sugar Free 1 mg/1 ml Oral Solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07BC", "N07BC02" ], "active_substances": [ "Methadone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/012/001", "product_name": "Ketovite Liquid", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A11BA" ], "active_substances": [ "Ergocalciferol", "Choline chloride", "Cyanocobalamin", "Vitamin A" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/013/001", "product_name": "Lisinopril 1 mg/ml Oral Solution", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2015-07-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril Dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/014/001", "product_name": "Monotrim 10 mg/ml Oral Suspension", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2006-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J01EA", "J01EA01" ], "active_substances": [ "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23081/018/001", "product_name": "Posiforlid 20 mg/g eye ointment", "holder": "Taw Pharma (Ireland) Limited", "authorised_date": "2025-07-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye ointment", "atc_codes": [ "S01AX05" ], "active_substances": [ "Bibrocathol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23086/001/001", "product_name": "Anafranil SR 75 mg Prolonged-release Tablets", "holder": "pharmaand GmbH", "authorised_date": "1988-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06AA", "N06AA04" ], "active_substances": [ "Clomipramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/001/001", "product_name": "Fulvestrant 250 mg solution for injection in pre-filled syringe", "holder": "Reddy Holding GmbH", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L02BA03" ], "active_substances": [ "Fulvestrant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/003/001", "product_name": "Bortezomib 3.5 mg powder for solution for injection", "holder": "Reddy Holding GmbH", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/004/001", "product_name": "Daptomycin 350 mg powder for solution for injection/infusion", "holder": "Reddy Holding GmbH", "authorised_date": "2024-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/004/002", "product_name": "Daptomycin 500 mg powder for solution for injection/infusion", "holder": "Reddy Holding GmbH", "authorised_date": "2024-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/006/001", "product_name": "Sugammadex 100 mg/ml solution for injection", "holder": "Reddy Holding GmbH", "authorised_date": "2022-10-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/007/001", "product_name": "Pazopanib Reddy 200 mg film-coated tablets", "holder": "Reddy Holding GmbH", "authorised_date": "2025-03-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01XE", "L01XE11" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23092/007/002", "product_name": "Pazopanib Reddy 400 mg film-coated tablets", "holder": "Reddy Holding GmbH", "authorised_date": "2025-03-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01EX03" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23101/001/001", "product_name": "Fefol Spansule 150 mg/0.5 mg Modified Release Capsules", "holder": "Intapharm Labs Ltd", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "B03AD", "B03AD03" ], "active_substances": [ "Dried ferrous sulphate", "Folic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23120/001/001", "product_name": "Hexiprep 2.0% w/v/70.0% v/v Impregnated Pad", "holder": "GAMA Healthcare Ireland Ltd", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Impregnated pad", "atc_codes": [ "D08AC52" ], "active_substances": [ "Chlorhexidine digluconate solution", "Isopropyl alcohol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23126/001/001", "product_name": "Solferol 400 IU Soft Capsules", "holder": "Windzor Pharma Ireland Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23126/001/002", "product_name": "Solferol 800 IU Soft Capsules", "holder": "Windzor Pharma Ireland Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23126/001/003", "product_name": "Solferol 1,000 IU Soft Capsules", "holder": "Windzor Pharma Ireland Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23126/001/004", "product_name": "Solferol 10,000 IU Soft Capsules", "holder": "Windzor Pharma Ireland Limited", "authorised_date": "2017-10-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23126/002/001", "product_name": "Solferol 20,000 IU Soft Capsules", "holder": "Windzor Pharma Ireland Limited", "authorised_date": "2016-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/003/001", "product_name": "Salactol Collodion", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1981-02-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Collodion", "atc_codes": [ "D11AF" ], "active_substances": [ "Salicylic acid", "Lactic acid" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/004/001", "product_name": "Anhydrol Forte 20% w/v Cutaneous Solution", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1982-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D11AA" ], "active_substances": [ "Aluminium chloride hexahydrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/005/001", "product_name": "Emulsiderm Emollient Bath Additive/Cutaneous Emulsion liquid paraffin 25% w/w, isopropyl myristate 25% w/w, benzalkonium chloride 0.5% w/w", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1982-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous emulsion", "atc_codes": [ "D02AX" ], "active_substances": [ "Isopropyl myristate", "Liquid paraffin", "Benzalkonium chloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/006/001", "product_name": "Exterol 5% w/w Ear Drops, Solution", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1982-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear drops, solution", "atc_codes": [ "S02AA06" ], "active_substances": [ "Urea hydrogen peroxide" ], "routes": [ "Auricular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/007/001", "product_name": "Salatac Gel Salicylic Acid 12.0% w/w Lactic Acid 4.0% w/w", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1989-11-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D11AF" ], "active_substances": [ "Salicylic acid", "Lactic acid" ], "routes": [ "Cutaneous use", "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/008/001", "product_name": "Capasal Therapeutic Shampoo", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1991-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D05AA" ], "active_substances": [ "Salicylic acid", "Coconut oil", "Coal tar" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/010/001", "product_name": "Betacap Scalp Application 0.1 % w/w cutaneous solution", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1993-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D07AC", "D07AC01" ], "active_substances": [ "Betamethasone valerate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/011/001", "product_name": "Ibugel 5% w/w Gel", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1995-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA13" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23128/012/001", "product_name": "Nicam 4% w/w Gel", "holder": "Dermal Laboratories (Ireland) Limited", "authorised_date": "1992-10-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AX" ], "active_substances": [ "Nicotinamide" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23137/001/001", "product_name": "Mercaptopurine Silver Pharma 50 mg tablets", "holder": "Silver Pharma S.L.", "authorised_date": "2021-07-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01BB02" ], "active_substances": [ "Mercaptopurine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/002/001", "product_name": "Vensir XL 75 mg prolonged-release hard capsules", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2008-08-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/002/002", "product_name": "Vensir XL 150 mg prolonged-release hard capsules", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2008-08-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/003/001", "product_name": "Buprenorphine 2 mg Sublingual Tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/003/002", "product_name": "Buprenorphine 8 mg Sublingual Tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/004/001", "product_name": "Ethambutol Hydrochloride 100mg film-coated tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J04AK", "J04AK02" ], "active_substances": [ "Ethambutol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/004/002", "product_name": "Ethambutol Hydrochloride 400mg film-coated tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J04AK", "J04AK02" ], "active_substances": [ "Ethambutol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/005/001", "product_name": "Methotrexate 10 mg tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2011-03-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AX", "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/005/002", "product_name": "Methotrexate 2.5mg tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2012-02-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AX", "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/006/001", "product_name": "Clorom XL 500 mg Prolonged-Release Tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2011-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/007/001", "product_name": "Lorazepam 1mg tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2012-12-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA06" ], "active_substances": [ "Lorazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/007/002", "product_name": "Lorazepam 2.5 mg tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2012-12-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA06" ], "active_substances": [ "Lorazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/008/001", "product_name": "Midodrine Hydrochloride Aspire 2.5 mg tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2022-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be 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"registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA13" ], "active_substances": [ "Leflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/009/002", "product_name": "Leflunomide 20mg film-coated tablets", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2011-08-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA13" ], "active_substances": [ "Leflunomide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"D07AB10" ], "active_substances": [ "Alclometasone dipropionate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/011/002", "product_name": "Modrasone Ointment 0.05% w/w", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "1984-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D07AB", "D07AB10" ], "active_substances": [ "Alclometasone dipropionate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/012/001", "product_name": "Bortezomib 1 mg powder for solution for injection", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX", "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/012/002", "product_name": "Bortezomib 3.5 mg powder for solution for injection", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2017-06-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX", "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/012/003", "product_name": "Bortezomib 2.5 mg powder for solution for injection", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2019-03-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/013/001", "product_name": "Eyzeetan 0.3 mg/ml + 5 mg/ml eye drops, solution", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED51" ], "active_substances": [ "Bimatoprost", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/014/001", "product_name": "Eyreida 0.3 mg/ml eye drops, solution", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2019-11-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EE03" ], "active_substances": [ "Bimatoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/015/001", "product_name": "Clindamycin + Benzoyl Peroxide 10 mg/g + 50 mg/g gel", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2021-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AF51" ], "active_substances": [ "Clindamycin", "Anhydrous Benzoyl Peroxide" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23142/016/001", "product_name": "Zindaclin 1% Gel", "holder": "Aspire Pharma (Malta) Limited", "authorised_date": "2002-11-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AF", "D10AF01" ], "active_substances": [ "CLINDAMYCIN PHOSPHATE" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23144/001/001", "product_name": "Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel", "holder": "Lobsor Pharmaceuticals AB", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Intestinal gel", "atc_codes": [ "N04BA03" ], "active_substances": [ "Levodopa", "Carbidopa monohydrate", "Entacapone" ], "routes": [ "Intestinal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/002/001", "product_name": "Phenoxymethylpenicillin Sugar Free 125 mg/5 ml Powder for Oral solution", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-03-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "Phenoxymethylpenicillin potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/002/002", "product_name": "Phenoxymethylpenicillin Sugar Free 250 mg/5 ml Powder for Oral solution", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-03-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "J01CE", "J01CE02" ], "active_substances": [ "Phenoxymethylpenicillin potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/003/001", "product_name": "Timolol 0.25% w/v Eye Drops, Solution", "holder": "Brown & Burk IR Limited", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "C07AA", "C07AA06" ], "active_substances": [ "Timolol" ], "routes": [ "Intraocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/003/002", "product_name": "Timolol 0.5% w/v Eye Drops, Solution", "holder": "Brown & Burk IR Limited", "authorised_date": "2013-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "C07AA", "C07AA06" ], "active_substances": [ "Timolol" ], "routes": [ "Intraocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/004/001", "product_name": "Co-amoxiclav 250mg/125mg Film-coated tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/004/002", "product_name": "Co-amoxiclav 500mg/125mg Film-coated tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/004/003", "product_name": "Co-amoxiclav 875mg/125mg Film-coated Tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/005/001", "product_name": "Co-amoxiclav Sugar Free 200 mg/28.5 mg/5 ml Powder for Oral Suspension", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/005/002", "product_name": "Co-Amoxiclav Sugar Free 400 mg/57 mg/5 ml Powder for Oral Suspension", "holder": "Brown & Burk IR Limited", "authorised_date": "2012-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/006/001", "product_name": "Griseofulvin 500 mg film-coated tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2011-03-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "D01BA", "D01BA01" ], "active_substances": [ "Griseofulvin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/008/001", "product_name": "Dorzolamide/Timolol Brown & Burk 20 mg/ml + 5 mg/ml eye drops, solution in single-dose container", "holder": "Brown & Burk IR Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01ED51" ], "active_substances": [ "Dorzolamide hydrochloride", "Timolol Maleate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/009/001", "product_name": "Clobazam Brown & Burk 10mg Tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2026-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/009/002", "product_name": "Clobazam Brown & Burk 20 mg Tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2026-04-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA09" ], "active_substances": [ "Clobazam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/010/001", "product_name": "Methenamine hippurate Brown & Burk 1 g tablets", "holder": "Brown & Burk IR Limited", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01XX05" ], "active_substances": [ "Methenamine hippurate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23148/011/001", "product_name": "Olopatadine Brown & Burk 1 mg/mL eye drops, solution", "holder": "Brown & Burk IR Limited", "authorised_date": "2025-05-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX09" ], "active_substances": [ "Olopatadine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/005/001", "product_name": "Raporsin 8 mg prolonged-release tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-11-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/005/002", "product_name": "Raporsin 4 mg prolonged-release tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-05-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/014/001", "product_name": "Telmisartan 20 mg Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/014/002", "product_name": "Telmisartan 40 mg Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/014/003", "product_name": "Telmisartan 80 mg Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/018/001", "product_name": "Etoricoxib 30 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/018/002", "product_name": "Etoricoxib 60 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/018/003", "product_name": "Etoricoxib 90 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-02-01", 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"holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/019/005", "product_name": "Atomoxetine Accord 60 mg hard capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/019/006", "product_name": "Atomoxetine Accord 80 mg hard capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/019/007", "product_name": "Atomoxetine Accord 100 mg Hard Capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA09" ], "active_substances": [ "Atomoxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/021/001", "product_name": "Anidulafungin 100 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-01-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J02AX06" ], "active_substances": [ "Anidulafungin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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"N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/034/001", "product_name": "Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-03-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "L01DB", "L01DB03" ], "active_substances": [ "Epirubicin hydrochloride" ], "routes": [ "Intravenous use", "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"atc_codes": [ "G04BD", "G04BD04" ], "active_substances": [ "Oxybutynin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/038/002", "product_name": "Oxybutynin Hydrochloride 5mg Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G04BD", "G04BD04" ], "active_substances": [ "Oxybutynin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/041/001", "product_name": "Tolterodine Tartrate 1 mg Film-coated Tablet", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/041/002", "product_name": "Tolterodine Tartrate 2 mg Film-coated Tablet", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/046/001", "product_name": "Fulvestrant 250 mg Solution for injection in pre-filled syringe", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L02BA", "L02BA03" ], "active_substances": [ "Fulvestrant" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/059/001", "product_name": "Losartan Potassium 25 mg Film-coated Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/059/002", "product_name": "Losartan Potassium 50 mg Film-coated Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be 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"market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L04AX", "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/060/002", "product_name": "Methofill 7.5 mg solution for injection in pre-filled injector", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled injector", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to 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"routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/060/009", "product_name": "Methofill 25 mg solution for injection in pre-filled injector", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled injector", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/060/010", "product_name": "Methofill 27.5 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"active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/061/001", "product_name": "Methotrexate 25 mg/ml Solution for Injection", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-09-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intraarterial use", "Intramuscular use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/061/002", "product_name": "Methotrexate 100 mg/ml concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/062/001", "product_name": "Methotrexate 2.5 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-07-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/062/002", "product_name": "Methotrexate 10 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-07-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/063/001", "product_name": "Midazolam 1 mg/ml Solution for Injection or Infusion", "holder": "Accord Healthcare 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[ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/063/005", "product_name": "Midazolam 2 mg/ml Solution for injection or infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2006-09-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N05CD", "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/063/006", "product_name": "Midazolam 5 mg/ml Solution for injection or infusion", "holder": "Accord 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"Mirtazapine 15 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2006-02-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/072/002", "product_name": "Mirtazapine 30 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2006-02-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/072/003", "product_name": "Mirtazapine 45 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2006-02-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/074/001", "product_name": "Olmesartan medoxomil/Amlodipine 20 mg/5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2018-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/074/002", "product_name": "Olmesartan medoxomil/Amlodipine 40 mg/5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2018-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/074/003", "product_name": "Olmesartan medoxomil/Amlodipine 40 mg/10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2018-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/075/001", "product_name": "Amlodipine 5 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/075/002", "product_name": "Amlodipine 10 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/076/001", "product_name": "Anastrozole 1 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2010-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/077/001", "product_name": "Bendamustine 25 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA09" ], "active_substances": [ "Bendamustine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/077/002", "product_name": "Bendamustine 100 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2014-10-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01AA", "L01AA09" ], "active_substances": [ "Bendamustine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"product_name": "Gemcitabine 1 g Powder for Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/092/003", "product_name": "Gemcitabine 2g Powder for Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/092/004", "product_name": "Gemcitabine 100 mg/ml Concentrate for Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-03-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BC", "L01BC05" ], "active_substances": [ "Gemcitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/099/001", "product_name": 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"Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/107/003", "product_name": "Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA", "C09DA07" ], "active_substances": [ "Telmisartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/108/001", "product_name": "Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-07-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01XX", "L01XX19" ], "active_substances": [ "Irinotecan hydrochloride trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/109/001", "product_name": "Letrozole 2.5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2010-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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"Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/110/003", "product_name": "Montelukast 10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2011-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/111/001", "product_name": "Naltrexone Hydrochloride 50mg film-coated tablets", "holder": "Accord 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"Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/132/005", "product_name": "Esomeprazole 40 mg powder for solution injection/infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole magnesium trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/134/001", "product_name": "Tendrotil SR 2 mg Prolonged-Release Capsules, Hard", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-09-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/134/002", "product_name": "Tendrotil SR 4 mg Prolonged-Release Capsules, Hard", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2012-09-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply 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"Brinzolamide 10 mg/ml eye drops, Suspension", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2015-10-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, suspension", "atc_codes": [ "S01EC", "S01EC04" ], "active_substances": [ "Brinzolamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/150/001", "product_name": "Candesartan 4 mg Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2011-04-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/157/002", "product_name": "Prasugrel Accord 10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC", "B01AC22" ], "active_substances": [ "Prasugrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/163/001", "product_name": "Furosemide 10 mg/ml Solution for Injection or Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2005-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C03CA", "C03CA01" ], "active_substances": [ "Furosemide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/164/001", "product_name": "Gabapentin 600 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2011-12-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BF01" ], "active_substances": [ 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"supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/170/001", "product_name": "Paracetamol 10 mg/ml Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/174/001", "product_name": "Rasagiline Accord 1 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2015-11-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BD", "N04BD02" ], "active_substances": [ "Rasagiline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/177/001", "product_name": "Sertraline 50 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/177/002", "product_name": "Sertraline 100 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/178/001", "product_name": "Tranexamic acid 100 mg/ml Solution for Injection", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B02AA", "B02AA02" ], "active_substances": [ "Tranexamic acid" ], 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"holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronate sodium monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/186/001", "product_name": "Lecalpin 10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-09-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription 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"Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "B01AC", "B01AC06" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/192/001", "product_name": "Mycophenolate Mofetil 500 mg film-coated Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2008-11-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA", "L04AA06" ], "active_substances": [ "Mycophenolate mofetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/194/001", "product_name": "Bisoprolol 2.5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2015-10-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/194/002", "product_name": "Bisoprolol 5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2015-10-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/194/003", "product_name": "Bisoprolol 10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2015-10-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/195/001", "product_name": "Atorvastatin 10 mg 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be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/195/003", "product_name": "Atorvastatin 40 mg Film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/195/004", "product_name": "Atorvastatin 80 mg Film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/197/001", "product_name": "Clarithromycin 250 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2017-04-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 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"2018-03-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA01" ], "active_substances": [ "Diazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/200/002", "product_name": "Emtricitabine/Tenofovir disoproxil Accordpharma 200 mg/245 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-06-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR03" ], "active_substances": [ "Emtricitabine", "Tenofovir disoproxil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/201/001", "product_name": "Etoposide 20 mg/ml Concentrate for Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01CB", "L01CB01" ], "active_substances": [ "Etoposide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/204/001", "product_name": "Metoclopramide hydrochloride 10 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2016-03-11", "product_type": "HM", 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"Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/218/001", "product_name": "Paracetamol 10 mg/ml solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/219/001", "product_name": "Allopurinol 100 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AA", "M04AA01" ], 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"authorised_date": "2014-02-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AH", "M01AH01" ], "active_substances": [ "Celecoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/229/001", "product_name": "Olanzapine 5 mg Orodispersible Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH", "N05AH03" ], "active_substances": [ "Olanzapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"product_name": "Zolmitriptan 2.5 mg Orodispersible Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2009-08-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02CC", "N02CC03" ], "active_substances": [ "Zolmitriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/235/001", "product_name": "Ambrisentan Accord 5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/235/002", "product_name": "Ambrisentan Accord 10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2019-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX", "C02KX02" ], "active_substances": [ "Ambrisentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/237/001", "product_name": "Daptomycin Accordpharma 350 mg powder for solution for injection/infusion", "holder": "Accord 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/239/001", "product_name": "Carmustine 100 mg powder and solvent for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for concentrate for solution for infusion", "atc_codes": [ "L01AD01" ], "active_substances": [ "Carmustine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/241/001", "product_name": "Enalapril maleate Accord 5 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"Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/241/003", "product_name": "Enalapril maleate Accord 20 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/243/001", "product_name": "Fesoterodine Accord 8 mg prolonged-release tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2021-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04BD11" ], "active_substances": [ "Fesoterodine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/245/001", "product_name": "Metformin Accord 500 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/245/002", "product_name": "Metformin Accord 850 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/245/003", "product_name": "Metformin Accord 1000 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-03-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BA02" ], "active_substances": [ "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/246/001", "product_name": "Loratadine Accord 10 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-10-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/247/001", "product_name": "Nebivolol Accord 5 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AB12" ], "active_substances": [ "Nebivolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/248/001", "product_name": "Sperizak 25 mg powder and solvent for prolonged-release suspension for injection", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/248/002", "product_name": "Sperizak 37.5 mg powder and solvent for prolonged-release suspension for injection", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/248/003", "product_name": "Sperizak 50 mg powder and solvent for prolonged-release suspension for injection", "holder": "Accord Healthcare 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"Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/250/002", "product_name": "Carmustine 300 mg powder and solvent for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for concentrate for solution for infusion", "atc_codes": [ "L01AD01" ], "active_substances": [ "Carmustine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/253/001", "product_name": "Vinorelbine Accord 20 mg soft capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01CA04" ], "active_substances": [ "Vinorelbine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/253/002", "product_name": "Vinorelbine Accord 30 mg soft capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01CA04" ], "active_substances": [ "Vinorelbine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/254/001", "product_name": "Naloxone Accord", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "V03AB15" ], "active_substances": [ "Naloxone hydrochloride dihydrate" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/255/001", "product_name": "Paracetamol/Codeine phosphate hemihydrate Accord 500 mg/30 mg tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-06-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/256/001", "product_name": "Rocuronium bromide Accord 10 mg/mL solution for injection in pre filled syringe", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-05-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion in pre-filled syringe", "atc_codes": [ "M03AC09" ], "active_substances": [ "Rocuronium bromide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/257/001", "product_name": "Enzalutamide Accord 40 mg soft capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L02BB04" ], "active_substances": [ "Enzalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/258/001", "product_name": "Daptomycin Accord Healthcare 350 mg powder for solution for injection/infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/258/002", "product_name": "Daptomycin Accord Healthcare 500 mg powder for solution for injection/infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XX09" ], "active_substances": [ "Daptomycin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/259/001", "product_name": "Ranolazine Accord 375 mg prolonged-release tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/259/002", "product_name": "Ranolazine Accord 500 mg prolonged-release tablet", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/259/003", "product_name": "Ranolazine Accord 750 mg prolonged-release tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01EB18" ], "active_substances": [ "Ranolazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/260/001", "product_name": "Protizole 20 mg gastro-resistant tablet", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2008-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/260/002", "product_name": "Protizole 40 mg gastro-resistant tablet", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2008-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC02" ], "active_substances": [ "Pantoprazole sodium sesquihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/261/001", "product_name": "Sildenvia 50 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/263/001", "product_name": "Orlistat Accord 120 mg hard capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A08AB01" ], "active_substances": [ "Orlistat" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/265/001", "product_name": "Pazopanib Accord 200 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/265/002", "product_name": "Pazopanib Accord 400 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-12-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L01" ], "active_substances": [ "Pazopanib hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/266/001", "product_name": "Paracetamol/Codeine Accord 500 mg/30 mg, effervescent Tablet", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/267/001", "product_name": "Paracetamol/Codeine Phosphate Hemihydrate/Caffeine Accord 500 mg/8 mg/30 mg Effervescent Tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-04-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "N02AJ06" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate", "Caffeine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/268/001", "product_name": "Duloxetine Accord 30 mg hard gastro-resistant capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-01-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/268/002", "product_name": "Duloxetine Accord 60 mg hard gastro-resistant capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-01-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "N06AX21" ], "active_substances": [ "Duloxetine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/269/001", "product_name": "Tacrolimus 0.03% ointment", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2022-11-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D11AH01" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/270/001", "product_name": "Pirfenidone Accord 267 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/270/002", "product_name": "Pirfenidone Accord 801 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/271/001", "product_name": "Sugammadex Accord 100 mg/mL solution for injection", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Not applicable", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/272/001", "product_name": "Nintedanib Accordpharma 100 mg soft capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/272/002", "product_name": "Nintedanib Accordpharma 150 mg soft capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "L01EX09" ], "active_substances": [ "Nintedanib esylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/273/001", "product_name": "Ticagrelor Accord 60 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-02-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/273/002", "product_name": "Ticagrelor Accord 90 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-02-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/274/001", "product_name": "Voriconazole Accord 200 mg Powder for Solution for Infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/275/001", "product_name": "Sacubitril/Valsartan Accord 24 mg/26 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/275/002", "product_name": "Sacubitril/Valsartan Accord 49 mg/51 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/275/003", "product_name": "Sacubitril/Valsartan Accord 97 mg/103 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DX04" ], "active_substances": [ "Sacubitril sodium", "Valsartan disodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/276/001", "product_name": "Eribulin Accord 0.44 mg/ml solution for injection", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX41" ], "active_substances": [ "Eribulin Mesilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/277/001", "product_name": "Atorvastatin Accord 10 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/277/002", "product_name": "Atorvastatin Accord 20 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/277/003", "product_name": "Atorvastatin Accord 40 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/279/001", "product_name": "Lenvatinib Accord 4 mg hard capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-08-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX08" ], "active_substances": [ "Lenvatinib besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/279/002", "product_name": "Lenvatinib Accord 10 mg hard capsules", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-08-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX08" ], "active_substances": [ "Lenvatinib besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/280/001", "product_name": "Linagliptin Accord 5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH05" ], "active_substances": [ "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/001", "product_name": "Selexipag Accord 200 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/002", "product_name": "Selexipag Accord 400 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/003", "product_name": "Selexipag Accord 600 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/004", "product_name": "Selexipag Accord 800 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/005", "product_name": "Selexipag Accord 1 000 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/006", "product_name": "Selexipag Accord 1 200 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/007", "product_name": "Selexipag Accord 1 400 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/281/008", "product_name": "Selexipag Accord 1 600 microgram film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC27" ], "active_substances": [ "Selexipag" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/282/001", "product_name": "Decitabine Accord 40 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BC08" ], "active_substances": [ "Decitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/282/002", "product_name": "Decitabine Accord 50 mg powder for concentrate for solution for infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "L01BC08" ], "active_substances": [ "Decitabine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/283/001", "product_name": "Colistimethate sodium Accord 1 million IU powder for solution for injection/infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XB01" ], "active_substances": [ "Colistimethate sodium" ], "routes": [ "Intracerebroventricular use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/283/002", "product_name": "Colistimethate sodium Accord 2 million IU powder for solution for injection/infusion", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01XB01" ], "active_substances": [ "Colistimethate sodium" ], "routes": [ "Intracerebroventricular use", "Intrathecal use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/286/001", "product_name": "Bosentan Accord 62.5 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX01" ], "active_substances": [ "Bosentan monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/286/002", "product_name": "Bosentan Accord 125 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-10-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX01" ], "active_substances": [ "Bosentan monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/288/001", "product_name": "Edoxaban Accord 15 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/288/002", "product_name": "Edoxaban Accord 30 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2315/288/003", "product_name": "Edoxaban Accord 60 mg film-coated tablets", "holder": "Accord Healthcare Ireland Ltd.", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF03" ], "active_substances": [ "Edoxaban tosylate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23153/001/001", "product_name": "Mucotex 250 mg/5 ml syrup", "holder": "Amdeepcha (Malta) Ltd", "authorised_date": "2019-01-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CB03" ], "active_substances": [ "Carbocisteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23154/001/001", "product_name": "Arimidex 1 mg film-coated tablets", "holder": "Laboratoires Juvise Pharmaceuticals", "authorised_date": "2000-08-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23154/002/001", "product_name": "Casodex 50 mg film-coated tablets", "holder": "Laboratoires Juvise Pharmaceuticals", "authorised_date": "2000-04-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23154/003/001", "product_name": "Pylera 140 mg/125 mg/125 mg capsules, hard", "holder": "Laboratoires Juvise Pharmaceuticals", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A02BD08" ], "active_substances": [ "Bismuth subcitrate potassium", "Metronidazole", "Tetracycline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23155/001/001", "product_name": "Folic Acid 400 microgram Tablets", "holder": "Generic Pharma International (G.P.I) Limited", "authorised_date": "2018-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "B03BB", "B03BB01" ], "active_substances": [ "Folic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23163/001/001", "product_name": "Astilin 10 mg film-coated tablets", "holder": "Ascot Laboratories (Ireland) Limited", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA", "N06AA09" ], "active_substances": [ "Amitriptyline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23163/001/002", "product_name": "Astilin 25 mg film-coated tablets", "holder": "Ascot Laboratories (Ireland) Limited", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA", "N06AA09" ], "active_substances": [ "Amitriptyline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23163/002/001", "product_name": "Methadone Hydrochloride 5 mg tablets", "holder": "Ascot Laboratories (Ireland) Limited", "authorised_date": "2018-09-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07BC", "N07BC02" ], "active_substances": [ "Methadone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23163/003/001", "product_name": "Acetylcysteine Essential-Healthcare 600 mg effervescent tablets", "holder": "Ascot Laboratories (Ireland) Limited", "authorised_date": "2018-03-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Effervescent tablet", "atc_codes": [ "R05CB", "R05CB01" ], "active_substances": [ "Acetylcysteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23163/004/001", "product_name": "Abendur 2.5 mg tablets", "holder": "Ascot Laboratories (Ireland) Limited", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03AA01" ], "active_substances": [ "Bendroflumethiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23163/004/002", "product_name": "Abendur 5 mg tablets", "holder": "Ascot Laboratories (Ireland) Limited", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C03AA01" ], "active_substances": [ "Bendroflumethiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23169/001/001", "product_name": "Fingolimod Tillomed 0.5 mg hard capsules", "holder": "Tillomed Pharma GmbH", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AE01" ], "active_substances": [ "Fingolimod" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23169/002/001", "product_name": "Midodrine Tillomed 2.5 mg tablets", "holder": "Tillomed Pharma GmbH", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23169/002/002", "product_name": "Midodrine Tillomed 5 mg tablets", "holder": "Tillomed Pharma GmbH", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23176/005/001", "product_name": "Trazodone Hydrochloride 50 mg/5 ml Oral Solution", "holder": "Lexon Pharmaceuticals (Ireland) Limited", "authorised_date": "2019-06-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06AX", "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2318/002/001", "product_name": "Doxorubicin Rivopharm 2 mg/ml concentrate for solution for infusion", "holder": "Rivopharm Limited", "authorised_date": "2011-12-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01DB", "L01DB01" ], "active_substances": [ "DOXORUBICIN HYDROCHLORIDE" ], "routes": [ "Intravenous use", "Intravesical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/001/001", "product_name": "NASACORT 55 micrograms/dose, nasal spray, suspension", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1998-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD11" ], "active_substances": [ "Triamcinolone acetonide" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/001/002", "product_name": "Nasacort Allergy 55 micrograms/dose nasal spray, suspension", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "2011-12-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD11" ], "active_substances": [ "Triamcinolone acetonide" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/003/001", "product_name": "Telfast 30 mg film-coated tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "2004-02-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06A" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/003/002", "product_name": "Telfast 120 mg film-coated tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1997-11-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/003/003", "product_name": "Telfast 180 mg film-coated tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1997-11-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/008/001", "product_name": "Maalox Plus 200 mg/175 mg/25 mg Oral Suspension", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1975-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02AF", "A02AF02" ], "active_substances": [ "Aluminium hydroxide", "Magnesium hydroxide", "Simeticone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/008/002", "product_name": "Maalox Plus Chewable Tablets 200 mg/200 mg/25 mg", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1975-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AF", "A02AF02" ], "active_substances": [ "ALUMINIUM OXIDE, HYDRATED PH. EUR", "MAGNESIUM HYDROXIDE PH. EUR.", "Dimeticone ph. eur. (as simeticone ph. eur.)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/009/001", "product_name": "Maalox 200mg/175mg per 5ml Oral Suspension", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1982-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A02AD", "A02AD01" ], "active_substances": [ "Magnesium hydroxide", "Aluminium hydroxide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/009/002", "product_name": "Maalox 400mg/400mg Chewable Tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1982-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02AD", "A02AD01" ], "active_substances": [ "Magnesium hydroxide", "Aluminium oxide, hydrated" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/011/001", "product_name": "Phenergan 5 mg/5 ml oral solution", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AD", "R06AD02" ], "active_substances": [ "Promethazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/011/002", "product_name": "Phenergan 25 mg film-coated tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AD", "R06AD02" ], "active_substances": [ "Promethazine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/013/001", "product_name": "Selsun Shampoo 2.5% w/v", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D11AC", "D11AC03" ], "active_substances": [ "Selenium disulfide" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/014/001", "product_name": "Telfast Allergy 120 mg film-coated tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "2013-03-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AX", "R06AX26" ], "active_substances": [ "Fexofenadine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/015/001", "product_name": "Bisolvon 4mg/5ml Oral Solution", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1984-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CB", "R05CB02" ], "active_substances": [ "Bromhexine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/016/001", "product_name": "Buscopan Ampoules 20 mg/ml Solution for Injection", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "A03BB", "A03BB01" ], "active_substances": [ "Hyoscine butylbromide" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/016/002", "product_name": "Buscopan 10 mg Coated Tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "A03BB", "A03BB01" ], "active_substances": [ "Hyoscine butylbromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/017/001", "product_name": "Dulcolax Pico Liquid 5 mg/5 ml oral solution", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1975-08-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AB", "A06AB08" ], "active_substances": [ "Sodium picosulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/018/002", "product_name": "Dulcolax 10 mg Suppositories", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1986-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A06AB", "A06AB02" ], "active_substances": [ "Bisacodyl" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/018/003", "product_name": "Dulcolax 5mg Gastro-resistant Tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "1986-06-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A06AB", "A06AB02" ], "active_substances": [ "Bisacodyl" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23180/022/001", "product_name": "Buscopan Rx 10mg Coated Tablets", "holder": "Opella Healthcare France SAS T/A Sanofi", "authorised_date": "2016-12-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "A03BB", "A03BB01" ], "active_substances": [ "Hyoscine butylbromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/002/001", "product_name": "Combogesic 10 mg/ml Paracetamol + 3 mg/ml Ibuprofen solution for infusion", "holder": "Jed Pharma Limited", "authorised_date": "2021-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen sodium dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/003/001", "product_name": "Expudyne 250 mg/5 ml oral solution", "holder": "Jed Pharma Limited", "authorised_date": "2023-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CB03" ], "active_substances": [ "Carbocisteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/005/001", "product_name": "Expudyne Rx 750 mg/5 ml oral solution", "holder": "Jed Pharma Limited", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CB03" ], "active_substances": [ "Carbocisteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/006/001", "product_name": "Ceftriaxone 1g powder for solution for injection/infusion", "holder": "Jed Pharma Limited", "authorised_date": "2023-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "J01DD04" ], "active_substances": [ "Ceftriaxone sodium" ], "routes": [ "Intramuscular use", "Intravenous bolus use", "Intravenous drip use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/009/001", "product_name": "Eptifibatide Jed 0.75 mg/ml solution for infusion", "holder": "Jed Pharma Limited", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B01AC16" ], "active_substances": [ "Eptifibatide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/009/002", "product_name": "Eptifibatide Jed 2 mg/ml solution for injection", "holder": "Jed Pharma Limited", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AC16" ], "active_substances": [ "Eptifibatide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/010/001", "product_name": "Esomeprazole Aristo 20 mg gastro-resistant capsules, hard", "holder": "Jed Pharma Limited", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole magnesium dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/010/002", "product_name": "Esomeprazole Aristo 40 mg gastro-resistant capsules, hard", "holder": "Jed Pharma Limited", "authorised_date": "2012-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/011/001", "product_name": "Levothyroxine sodium Aristo 25 micrograms tablets", "holder": "Jed Pharma Limited", "authorised_date": "2020-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/011/002", "product_name": "Levothyroxine sodium Aristo 50 micrograms tablets", "holder": "Jed Pharma Limited", "authorised_date": "2020-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23183/011/003", "product_name": "Levothyroxine sodium Aristo 100 micrograms tablets", "holder": "Jed Pharma Limited", "authorised_date": "2020-01-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H03AA", "H03AA01" ], "active_substances": [ "Levothyroxine sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23188/001/001", "product_name": "Carnation Corn Caps 40% w/w Medicated plasters", "holder": "Cuxson Gerrard Healthcare Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "D11AF" ], "active_substances": [ "Salicylic acid" ], "routes": [ "Route of administration not applicable" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23188/001/002", "product_name": "Carnation Callous Caps 40% w/w Medicated plasters", "holder": "Cuxson Gerrard Healthcare Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "D11AF" ], "active_substances": [ "Salicylic acid" ], "routes": [ "Route of administration not applicable" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23188/001/003", "product_name": "Carnation Vericap Verruca Treatment 10% w/w medicated plaster", "holder": "Cuxson Gerrard Healthcare Limited", "authorised_date": "1990-01-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "D02AF" ], "active_substances": [ "Salicylic acid" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23188/002/001", "product_name": "Belladonna 0.25% w/w Medicated Plaster", "holder": "Cuxson Gerrard Healthcare Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "M02AX", "M02AX10" ], "active_substances": [ "Belladonna alkaloids" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23198/001/001", "product_name": "Cozaar Comp 100 mg/12.5 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2008-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/001/002", "product_name": "Cozaar Comp 50 mg/12.5 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1997-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/001/003", "product_name": "Cozaar Comp 100mg/25mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/002/001", "product_name": "Cozaar 12.5mg Film-coated Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/002/002", "product_name": "Cozaar 50 mg Film-coated Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1995-06-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/002/003", "product_name": "Cozaar 100 mg Film-coated Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/003/001", "product_name": "FOSAMAX Once Weekly 70 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2001-05-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/004/001", "product_name": "Sinemet 12.5 mg/50 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1990-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Carbidopa", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/004/002", "product_name": "Sinemet 10 mg/100 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Carbidopa", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/004/003", "product_name": "Sinemet Plus 25 mg/100 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1981-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/004/004", "product_name": "Sinemet 25 mg/250 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/004/005", "product_name": "Sinemet CR 50mg/200 mg Prolonged-release Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1991-12-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/004/006", "product_name": "Half Sinemet CR 25mg/100mg Prolonged-Release Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1993-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BA", "N04BA02" ], "active_substances": [ "Levodopa", "Carbidopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/005/001", "product_name": "Innovace 2.5 mg Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1987-07-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/005/002", "product_name": "Innovace 5 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1985-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/005/003", "product_name": "Innovace 10 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1985-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/005/004", "product_name": "Innovace 20 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1985-09-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/006/001", "product_name": "Innozide 20 mg/12.5 mg Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1991-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09BA", "C09BA02" ], "active_substances": [ "Enalapril maleate", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/007/001", "product_name": "Proscar 5mg Film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1992-08-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04CB", "G04CB01" ], "active_substances": [ "Finasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/008/001", "product_name": "Zocor 10 mg, film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1989-11-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/008/002", "product_name": "Zocor 20 mg, film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1989-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/008/003", "product_name": "Zocor 40 mg, film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1989-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/009/001", "product_name": "DiproSalic 0.05% w/w + 2% w/w scalp application", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1983-10-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D07XC", "D07XC01" ], "active_substances": [ "Betamethasone dipropionate", "Salicylic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/010/001", "product_name": "Elocon 0.1% w/w Cream", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1993-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07AC13" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/010/002", "product_name": "Elocon 0.1% w/w Ointment", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1993-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D07AC", "D07AC13" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/010/003", "product_name": "Elocon 0.1% w/w Scalp Lotion, Cutaneous Solution", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1993-12-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D07AC", "D07AC13" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/011/001", "product_name": "NASONEX 50 micrograms/actuation Nasal Spray, Suspension", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1998-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD09" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/012/001", "product_name": "Asmanex Twisthaler 200 micrograms Inhalation Powder", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2002-04-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03BA", "R03BA07" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/012/002", "product_name": "Asmanex Twisthaler 400 micrograms Inhalation Powder", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2002-04-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03BA", "R03BA07" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/014/001", "product_name": "Singulair Paediatric 4 mg chewable tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1998-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/014/003", "product_name": "Singulair Paediatric 5 mg chewable tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1998-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/014/004", "product_name": "Singulair 10 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1998-02-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/015/001", "product_name": "Zispin SolTab 15 mg orodispersible tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2003-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/015/002", "product_name": "Zispin SolTab 30 mg orodispersible tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2003-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/015/003", "product_name": "Zispin SolTab 45 mg orodispersible tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2003-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/016/001", "product_name": "Cerazette 75 microgram film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1998-08-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03AC", "G03AC09" ], "active_substances": [ "Desogestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/017/001", "product_name": "Implanon NXT, 68 mg implant for subdermal use", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1999-03-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "G03AC", "G03AC08" ], "active_substances": [ "Etonogestrel" ], "routes": [ "Implantation" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/018/001", "product_name": "Marviol 150/30 microgram Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1983-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AA", "G03AA09" ], "active_substances": [ "Desogestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/019/001", "product_name": "Mercilon 150/20 microgram Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1988-05-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AA", "G03AA09" ], "active_substances": [ "Desogestrel", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/020/001", "product_name": "NuvaRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2002-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Vaginal delivery system", "atc_codes": [ "G03BB", "G03BB01" ], "active_substances": [ "Etonogestrel", "Ethinylestradiol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/021/001", "product_name": "Livial 2.5 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1987-12-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03CX", "G03CX01" ], "active_substances": [ "Tibolone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/022/001", "product_name": "Atozet 10 mg/10 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/022/002", "product_name": "Atozet 10 mg/20 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/022/003", "product_name": "Atozet 10 mg/40 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/022/004", "product_name": "Atozet 10 mg/80 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2014-11-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/023/001", "product_name": "Ezetrol 10 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AX", "C10AX09" ], "active_substances": [ "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/024/001", "product_name": "Inegy 10mg/10mg Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2004-12-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/024/002", "product_name": "Inegy 10 mg/20 mg Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2004-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/024/003", "product_name": "Inegy 10 mg/40 mg tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2004-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/024/004", "product_name": "Inegy 10 mg/80 mg Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2004-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10BA", "C10BA02" ], "active_substances": [ "Ezetimibe", "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/025/001", "product_name": "Zispin 15 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1997-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/025/002", "product_name": "Zispin 30 mg film-coated tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "1997-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX11" ], "active_substances": [ "Mirtazapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/026/001", "product_name": "Monadia 50mcg/actuation Nasal spray, suspension", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2024-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD09" ], "active_substances": [ "Mometasone furoate monohydrate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/027/001", "product_name": "Rizadia 5 mg oral lyophilisate", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2024-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02CC04" ], "active_substances": [ "Rizatriptan benzoate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23198/027/002", "product_name": "Rizadia 5 mg Tablets", "holder": "Organon Pharma (Ireland) Limited", "authorised_date": "2024-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02CC04" ], "active_substances": [ "Rizatriptan benzoate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23199/001/001", "product_name": "Isoprenaline hydrochloride Macure 0.2 mg/ml concentrate for solution for infusion", "holder": "Macure Pharma ApS", "authorised_date": "2021-07-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA02" ], "active_substances": [ "Isoprenaline hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23199/002/001", "product_name": "Lorazepam Macure 4 mg/ml solution for injection", "holder": "Macure Pharma ApS", "authorised_date": "2021-11-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05BA06" ], "active_substances": [ "Lorazepam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23199/003/001", "product_name": "Diazepam Macure 5 mg/ml emulsion for injection", "holder": "Macure Pharma ApS", "authorised_date": "2026-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Emulsion for injection", "atc_codes": [ "N05BA01" ], "active_substances": [ "Diazepam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA2321/002/001", "product_name": "Esomeprazole Tillomed 40 mg powder for solution for injection/infusion", "holder": "Laboratorios Tillomed Spain, S.L.U.", "authorised_date": "2020-02-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA2321/003/001", "product_name": "Treosulfan Tillomed 5 g powder for solution for infusion", "holder": "Laboratorios Tillomed Spain, S.L.U.", "authorised_date": "2019-03-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "L01AB02" ], "active_substances": [ "Treosulfan" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/001/001", "product_name": "Equasym XL 10 mg modified-release capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2006-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/001/002", "product_name": "Equasym XL 20 mg modified-release capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2006-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/001/003", "product_name": "Equasym XL 30 mg modified-release capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2006-07-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/001/004", "product_name": "Equasym XL 40 mg modified-release capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/001/005", "product_name": "Equasym XL 50 mg modified-release capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/001/006", "product_name": "Equasym XL 60 mg modified-release capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "N06BA", "N06BA04" ], "active_substances": [ "Methylphenidate hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/002/001", "product_name": "Foznol 250 mg Chewable Tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2005-06-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum carbonate hydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/002/002", "product_name": "Foznol 500 mg Chewable Tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2005-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/002/003", "product_name": "Foznol 750 mg Chewable Tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2005-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/002/004", "product_name": "Foznol 1000 mg Chewable Tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2005-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/002/005", "product_name": "Foznol 750 mg Oral Powder", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral powder", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum carbonate hydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/002/006", "product_name": "Foznol 1000 mg Oral Powder", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral powder", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum carbonate hydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/004/001", "product_name": "Mezavant XL 1200 mg gastro-resistant, prolonged release tablets", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2007-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/005/001", "product_name": "Tyvense 20 mg capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2015-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA", "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/005/002", "product_name": "Tyvense 30 mg capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06", "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/005/003", "product_name": "Tyvense 40 mg capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2015-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA", "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/005/004", "product_name": "Tyvense 50 mg capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06", "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/005/005", "product_name": "Tyvense 60 mg capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2015-07-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06BA", "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23211/005/006", "product_name": "Tyvense 70 mg capsules, hard", "holder": "Takeda Pharmaceuticals International AG Ireland Branch", "authorised_date": "2013-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06", "N06BA12" ], "active_substances": [ "Lisdexamfetamine dimesylate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23214/001/001", "product_name": "Finovare 20 mg/g Cream", "holder": "Citrine Healthcare Limited", "authorised_date": "2023-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06AX01" ], "active_substances": [ "Fusidic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23214/002/001", "product_name": "Pruridene 1 mg/g Gel", "holder": "Citrine Healthcare Limited", "authorised_date": "2024-08-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D04AA13" ], "active_substances": [ "Dimetindene maleate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23217/001/001", "product_name": "Amoxicillin Delbert 500 mg powder for solution for injection or infusion", "holder": "Laboratoires DELBERT", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CA", "J01CA04" ], "active_substances": [ "Amoxicillin" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2322/001/001", "product_name": "AmBisome Liposomal Amphotericin B 50 mg Powder for Concentrate for Dispersion for Infusion", "holder": "Gilead Sciences Ireland UC", "authorised_date": "1990-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J02AA", "J02AA01" ], "active_substances": [ "Amphotericin b" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/008/001", "product_name": "Nozinan 25 mg/ml solution for injection/infusion", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1983-01-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N05AA", "N05AA02" ], "active_substances": [ "LEVOMEPROMAZINE HYDROCHLORIDE" ], "routes": [ "Intramuscular use", "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/009/001", "product_name": "Surmontil 50mg hard Capsules", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AA", "N06AA06" ], "active_substances": [ "Trimipramine maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/009/002", "product_name": "Surmontil 25mg film-coated Tablets", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AA", "N06AA06" ], "active_substances": [ "Trimipramine maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/010/001", "product_name": "Dolmatil 200mg Tablets", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1987-04-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AL", "N05AL01" ], "active_substances": [ "Sulpiride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/011/001", "product_name": "Molipaxin 50 mg capsules", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1977-02-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX", "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/011/002", "product_name": "Molipaxin 100 mg capsules", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1977-02-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N06AX", "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23229/011/003", "product_name": "Molipaxin 150mg Film-coated Tablets", "holder": "Neuraxpharm Ireland Limited", "authorised_date": "1985-12-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX", "N06AX05" ], "active_substances": [ "Trazodone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2324/001/001", "product_name": "Livazo 1mg film-coated tablets", "holder": "Kowa Pharmaceutical Europe GmbH", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA08" ], "active_substances": [ "Pitavastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2324/001/002", "product_name": "Livazo 2mg film-coated tablets", "holder": "Kowa Pharmaceutical Europe GmbH", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA08" ], "active_substances": [ "Pitavastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2324/001/003", "product_name": "Livazo 4mg film-coated tablets", "holder": "Kowa Pharmaceutical Europe GmbH", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA08" ], "active_substances": [ "Pitavastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2325/002/001", "product_name": "Ametop 40 mg/g Gel", "holder": "Alliance Pharma (Ireland) Limited", "authorised_date": "2018-07-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "N01BA", "N01BA03" ], "active_substances": [ "Tetracaine base" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2325/003/001", "product_name": "Anbesol Anaesthetic Antiseptic Oromucosal Solution", "holder": "Alliance Pharma (Ireland) Limited", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal solution", "atc_codes": [ "N01BB", "N01BB52" ], "active_substances": [ "Lidocaine hydrochloride", "Chlorocresol", "Cetylpyridinium chloride" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2325/009/001", "product_name": "Naseptin 0.1% & 0.5% w/w Nasal Cream", "holder": "Alliance Pharma (Ireland) Limited", "authorised_date": "1998-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal cream", "atc_codes": [ "D06AX", "D06AX04" ], "active_substances": [ "Chlorhexidine Dihydrochloride", "Neomycin sulfate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2325/010/001", "product_name": "Nu-seals 75 mg gastro-resistant tablets", "holder": "Alliance Pharma (Ireland) Limited", "authorised_date": "2002-04-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "B01AC", "B01AC06" ], "active_substances": [ "Acetylsalicylic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2325/011/001", "product_name": "Occlusal 26% w/w Cutaneous Solution", "holder": "Alliance Pharma (Ireland) Limited", "authorised_date": "2004-04-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D02AF" ], "active_substances": [ "Salicylic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA2325/015/001", "product_name": "Thwart 26% w/w Cutaneous Solution", "holder": "Alliance Pharma (Ireland) Limited", "authorised_date": "2002-04-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D02AF" ], "active_substances": [ "Salicylic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23250/001/001", "product_name": "Plerixafor 20 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"dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/003/001", "product_name": "Bortezomib 3.5 mg powder for solution for injection", "holder": "MSN Labs Europe Limited", "authorised_date": "2022-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/004/001", "product_name": "Rivaroxaban MSN 2.5 mg film-coated tablets", "holder": "MSN Labs 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"B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/005/001", "product_name": "Clopidogrel MSN 75 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC04" ], "active_substances": [ "Clopidogrel Hydrogen Sulfate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/007/001", "product_name": "Fingolimod MSN 0.5 mg hard 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prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/008/002", "product_name": "Sitagliptin/Metformin MSN 50 mg/1000 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin hydrochloride", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/009/001", "product_name": "Tapentadol MSN 25 mg prolonged-release tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/009/002", "product_name": "Tapentadol MSN 50 mg prolonged-release tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/009/005", "product_name": "Tapentadol MSN 200 mg prolonged-release tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/009/006", "product_name": "Tapentadol MSN 250 mg prolonged-release tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AX06" ], "active_substances": [ "Tapentadol tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/010/001", "product_name": "Dimethyl fumarate MSN 120 mg gastro-resistant hard capsules", "holder": "MSN Labs Europe Limited", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/010/002", "product_name": "Dimethyl fumarate MSN 240 mg gastro-resistant hard capsules", "holder": "MSN Labs Europe Limited", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/011/001", "product_name": "Eltrombopag MSN 25 mg 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be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/012/001", "product_name": "Sugammadex 100 mg/mL solution for injection", "holder": "MSN Labs Europe Limited", "authorised_date": "2024-01-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/013/001", "product_name": "Apixaban MSN 2.5 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/013/002", "product_name": "Apixaban MSN 5 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/014/001", "product_name": "Eplerenone MSN 25 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/014/002", "product_name": "Eplerenone MSN 50 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/017/001", "product_name": "Macitentan MSN 10 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-06-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/020/001", "product_name": "Dapagliflozin MSN 5 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/020/002", "product_name": "Dapagliflozin MSN 10 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BK01" ], "active_substances": [ "Dapagliflozin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/023/001", "product_name": "Pirfenidone MSN 267 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/023/002", "product_name": "Pirfenidone MSN 801 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/024/001", "product_name": "Ticagrelor MSN 60 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/024/002", "product_name": "Ticagrelor MSN 90 mg film-coated tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AC24" ], "active_substances": [ "Ticagrelor" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23250/025/001", "product_name": "Naproxen/Esomeprazole MSN 500 mg/20 mg modified-release tablets", "holder": "MSN Labs Europe Limited", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AE52" ], "active_substances": [ "Naproxen", "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23258/001/001", "product_name": "Enoxaparin sodium Ledraxen 10,000 IU (100 mg)/1 mL, solution for injection in pre-filled syringe", "holder": "Venipharm", "authorised_date": "2022-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA23258/001/002", "product_name": "Enoxaparin sodium Ledraxen 8,000 IU (80 mg)/0.8 mL, solution for injection in pre-filled syringe", "holder": "Venipharm", "authorised_date": "2022-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA23258/001/003", "product_name": "Enoxaparin sodium Ledraxen 6,000 IU (60 mg)/0.6 mL, solution for injection in pre-filled syringe", "holder": "Venipharm", "authorised_date": "2022-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA23258/001/004", "product_name": "Enoxaparin sodium Ledraxen 4,000 IU (40 mg)/0.4 mL, solution for injection in pre-filled syringe", "holder": "Venipharm", "authorised_date": "2022-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA23258/001/005", "product_name": "Enoxaparin sodium Ledraxen 2,000 IU (20 mg)/0.2 mL, solution for injection in pre-filled syringe", "holder": "Venipharm", "authorised_date": "2022-09-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Similar biological application (Article 10(4) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/004/001", "product_name": "Artelac 3.2 mg/ml Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1996-07-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Hypromellose" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/004/002", "product_name": "Artelac Preservative Free Single Dose Unit", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1996-07-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Hypromellose" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/005/002", "product_name": "Vividrin Preservative Free SDU 2% w/v Eye Drops solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "2000-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX01" ], "active_substances": [ "Sodium cromoglycate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/006/001", "product_name": "Geltears 0.2 % w/w carbomer eye gel", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1997-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carbomer" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/007/001", "product_name": "Minims Atropine Sulphate 1% Eye Drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01FA", "S01FA01" ], "active_substances": [ "Atropine sulfate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23259/008/001", "product_name": "Vidisic 0.2 % w/w eye gel", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1993-08-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carbomer" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/008/002", "product_name": "Vidisic Preservative Free Single Dose Unit", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "2001-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carbomer" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/009/001", "product_name": "Liposic 2 mg/g eye gel", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "2002-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye gel", "atc_codes": [ "S01XA", "S01XA20" ], "active_substances": [ "Carbomer" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/010/001", "product_name": "Minims Chloramphenicol 0.5% Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AA", "S01AA01" ], "active_substances": [ "Chloramphenicol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/011/001", "product_name": "Minims Cyclopentolate Hydrochloride 1% w/v Eye Drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01FA", "S01FA04" ], "active_substances": [ "Cyclopentolate hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/012/002", "product_name": "Minims Fluorescein Sodium 2%, w/v Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01JA", "S01JA01" ], "active_substances": [ "Fluorescein sodium" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/013/001", "product_name": "Minims Artificial Tears 0.35% w/w + 0.44% w/w Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1992-03-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AX", "S01AX07" ], "active_substances": [ "Sodium chloride", "Hydroxyethylcellulose" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/014/001", "product_name": "Minims Lidocaine Hydrochloride 4% w/v & Fluorescein Sodium 0.25% w/v Eye Drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1983-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01JA", "S01JA51" ], "active_substances": [ "Fluorescein sodium", "Lidocaine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/015/001", "product_name": "Minims Oxybuprocaine Hydrochloride 0.4% w/v Eye Drops Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01HA", "S01HA02" ], "active_substances": [ "Oxybuprocaine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/016/001", "product_name": "Minims Phenylephrine Hydrochloride 2.5% w/v eye drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1990-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GA", "S01GA05" ], "active_substances": [ "Phenylephrine hydrochloride" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/017/001", "product_name": "Minims Pilocarpine Nitrate 2% w/v, Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EB", "S01EB01" ], "active_substances": [ "Pilocarpine nitrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/018/001", "product_name": "Minims Povidone Iodine 5% w/v Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "2012-12-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AX", "S01AX18" ], "active_substances": [ "Iodinated povidone" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/019/001", "product_name": "Minims Prednisolone Sodium Phosphate 0.5% w/v Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1982-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01BA", "S01BA04" ], "active_substances": [ "Prednisolone sodium phosphate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/020/001", "product_name": "Minims Proxymetacaine hydrochloride 0.5% w/v, Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "2001-03-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01HA", "S01HA04" ], "active_substances": [ "PROXYMETACAINE HYDROCHLORIDE" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/021/001", "product_name": "Minims Saline 0.9% w/v Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1983-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AX", "S01AX03" ], "active_substances": [ "Sodium chloride" ], "routes": [ "Ocular use", "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/022/001", "product_name": "Minims Tetracaine Hydrochloride 0.5% w/v Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01HA", "S01HA03" ], "active_substances": [ "Tetracaine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/022/002", "product_name": "Minims Tetracaine Hydrochloride 1% w/v Eye Drops, Solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01HA", "S01HA03" ], "active_substances": [ "Tetracaine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/023/001", "product_name": "Minims Tropicamide 0.5 % w/v Eye drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1982-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01FA", "S01FA06" ], "active_substances": [ "Tropicamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/023/002", "product_name": "Minims Tropicamide 1% w/v Eye drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "1987-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01FA", "S01FA06" ], "active_substances": [ "Tropicamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23259/024/001", "product_name": "Lumobry 0.25 mg/mL eye drops, solution", "holder": "Bausch + Lomb Ireland Limited", "authorised_date": "2024-06-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GA" ], "active_substances": [ "Brimonidine tartrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/001/001", "product_name": "Movicol Chocolate 13.9 g sachet powder for oral solution", "holder": "Norgine Healthcare B.V.", "authorised_date": "2008-11-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Potassium chloride", "Sodium hydrogen carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/001/002", "product_name": "Movicol Paediatric Chocolate Flavour 6.9 g sachet powder for oral solution", "holder": "Norgine Healthcare B.V.", "authorised_date": "2004-11-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium bicarbonate", "Sodium chloride", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/001/003", "product_name": "Movicol Paediatric Plain 6.9 g sachet powder for oral solution", "holder": "Norgine Healthcare B.V.", "authorised_date": "2006-01-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium bicarbonate", "Sodium chloride", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/001/004", "product_name": "Movicol Plain 13.7 g sachet powder for oral solution", "holder": "Norgine Healthcare B.V.", "authorised_date": "2009-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium bicarbonate", "Sodium chloride", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/001/005", "product_name": "Movicol 13.8 g sachet powder for oral solution", "holder": "Norgine Healthcare B.V.", "authorised_date": "1996-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium bicarbonate", "Sodium chloride", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/002/001", "product_name": "Movicol Liquid Orange Flavour, Concentrate for Oral Solution", "holder": "Norgine Healthcare B.V.", "authorised_date": "2012-01-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23265/002/002", "product_name": "Movicol Ready to Take 13.9 g/25 ml oral solution in sachet", "holder": "Norgine Healthcare B.V.", "authorised_date": "2016-09-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution in sachet", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/001/001", "product_name": "Atorvastatin Viatris 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-02-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/001/002", "product_name": "Atorvastatin Viatris 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/001/003", "product_name": "Atorvastatin Viatris 40 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/001/004", "product_name": "Atorvastatin Viatris 80 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/002/001", "product_name": "Amlodipine Viatris 5 mg tablets", "holder": "Viatris Limited", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/002/002", "product_name": "Amlodipine Viatris 10 mg tablets", "holder": "Viatris Limited", "authorised_date": "2010-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/003/001", "product_name": "Rosuvastatin Viatris 5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/003/002", "product_name": "Rosuvastatin Viatris 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/003/003", "product_name": "Rosuvastatin Viatris 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/003/004", "product_name": "Rosuvastatin Viatris 40 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/004/001", "product_name": "Vancomycin Viatris 500 mg, powder for solution for infusion", "holder": "Viatris Limited", "authorised_date": "2011-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "Vancomycin" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/004/002", "product_name": "Vancomycin Viatris 1000 mg, powder for solution for infusion", "holder": "Viatris Limited", "authorised_date": "2011-10-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01XA", "J01XA01" ], "active_substances": [ "Vancomycin" ], "routes": [ "Intravenous use", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/005/001", "product_name": "Desunin 10 000 IU soft capsules", "holder": "Viatris Limited", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/005/002", "product_name": "Desunin 25,000 IU soft capsules", "holder": "Viatris Limited", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC05" ], "active_substances": [ "Vitamin d3" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through 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"atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/006/003", "product_name": "Valsartan Viatris 160 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/006/004", "product_name": "Valsartan Viatris 320 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/009/001", "product_name": "Zimoclone 7.5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2000-04-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/010/001", "product_name": "Brabio 20 mg/ml solution for injection, pre-filled syringe", "holder": "Viatris Limited", "authorised_date": "2016-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AX", "L03AX13" ], "active_substances": [ "Glatiramer acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/011/001", "product_name": "Brabio 40 mg/ml solution for injection in pre-filled syringe", "holder": "Viatris Limited", "authorised_date": "2017-11-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AX", "L03AX13" ], "active_substances": [ "Glatiramer acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/012/001", "product_name": "Lanreotide Viatris 60 mg solution for injection in a pre-filled syringe", "holder": "Viatris Limited", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/012/002", "product_name": "Lanreotide Viatris 90 mg solution for injection in a pre-filled syringe", "holder": "Viatris Limited", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/012/003", "product_name": "Lanreotide Viatris 120 mg solution for injection in a pre-filled syringe", "holder": "Viatris Limited", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/013/001", "product_name": "Linagliptin Viatris 5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2024-02-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH05" ], "active_substances": [ "Linagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/014/001", "product_name": "Sotoger 80mg Tablets", "holder": "Viatris Limited", "authorised_date": "1996-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C07AA", "C07AA07" ], "active_substances": [ "SOTALOL HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/015/001", "product_name": "Germentin 500 mg/125 mg film coated tablets", "holder": "Viatris Limited", "authorised_date": "2000-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin trihydrate", "potassium clavulanate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/015/002", "product_name": "Germentin 125 mg/31.25 mg per 5 ml Powder for Oral Suspension", "holder": "Viatris Limited", "authorised_date": "2004-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral suspension", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Clavulanic acid", "Amoxicillin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/015/003", "product_name": "Germentin 250 mg/125 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2004-03-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR", "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/016/001", "product_name": "Tamsulosin 400 micrograms Modified-release Capsules, Hard", "holder": "Viatris Limited", "authorised_date": "2006-03-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/017/001", "product_name": "Zirtene 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2006-06-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R06AE", "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/018/001", "product_name": "Fostepor Once Weekly 70mg tablets", "holder": "Viatris Limited", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M05BA", "M05BA04" ], "active_substances": [ "Alendronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/019/001", "product_name": "Baclopar 10 mg Tablets", "holder": "Viatris Limited", "authorised_date": "1989-11-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX01" ], "active_substances": [ "Baclofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/020/001", "product_name": "Sirdupla 25 microgram/125 microgram per metered dose pressurised inhalation, suspension", "holder": "Viatris Limited", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/020/002", "product_name": "Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension", "holder": "Viatris Limited", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/021/001", "product_name": "Piperacillin Tazobactam 2 g/0.25 g powder for solution for infusion", "holder": "Viatris Limited", "authorised_date": "2010-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin sodium", "Tazobactam (as sodium salt)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/021/002", "product_name": "Piperacillin Tazobactam 4 g/0.5 g powder for solution for infusion", "holder": "Viatris Limited", "authorised_date": "2010-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin sodium", "Tazobactam (as sodium salt)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/022/001", "product_name": "Montelukast Viatris 4 mg Chewable Tablets", "holder": "Viatris Limited", "authorised_date": "2011-05-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/022/002", "product_name": "Montelukast Viatris 5 mg Chewable Tablets", "holder": "Viatris Limited", "authorised_date": "2011-05-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/024/001", "product_name": "Letrozole Viatris 2.5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-05-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/025/001", "product_name": "Montelukast Viatris 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/026/001", "product_name": "Pravastatin Viatris 10 mg Tablets", "holder": "Viatris Limited", "authorised_date": "2010-12-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/026/002", "product_name": "Pravastatin Viatris 20 mg Tablets", "holder": "Viatris Limited", "authorised_date": "2010-12-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/026/003", "product_name": "Pravastatin Viatris 40 mg Tablets", "holder": "Viatris Limited", "authorised_date": "2010-12-17", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AA", "C10AA03" ], "active_substances": [ "Pravastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/027/001", "product_name": "Ibandronic Acid Viatris 150 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2010-07-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA", "M05BA06" ], "active_substances": [ "Ibandronic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/028/001", "product_name": "Olmesartan/Amlodipine Viatris 20 mg/5 mg film coated tablets", "holder": "Viatris Limited", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodpine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/028/002", "product_name": "Olmesartan/Amlodipine Viatris 40 mg/5 mg film coated tablets", "holder": "Viatris Limited", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodpine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/028/003", "product_name": "Olmesartan/Amlodipine Viatris 40 mg/10 mg film coated tablets", "holder": "Viatris Limited", "authorised_date": "2018-05-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DB", "C09DB02" ], "active_substances": [ "Olmesartan medoxomil", "Amlodpine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/029/001", "product_name": "Agomelatine Viatris 25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2018-10-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AX22" ], "active_substances": [ "Agomelatine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/030/001", "product_name": "Posaconazole Viatris 100 mg gastro-resistant tablets", "holder": "Viatris Limited", "authorised_date": "2019-12-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "J02AC", "J02AC04" ], "active_substances": [ "Posaconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/031/001", "product_name": "Sitagliptin Viatris 25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/031/002", "product_name": "Sitagliptin Viatris 50 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-06-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BH01" ], "active_substances": [ "Sitagliptin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of 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"2015-02-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "A10BB", "A10BB09" ], "active_substances": [ "Gliclazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/034/001", "product_name": "Imuger 25 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2000-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX", "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic 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], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/037/001", "product_name": "Nailderm 250 mg tablets", "holder": "Viatris Limited", "authorised_date": "2005-06-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "D01BA", "D01BA02" ], "active_substances": [ "Terbinafine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/038/001", "product_name": "Cifloxager 250 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2005-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/038/002", "product_name": "Cifloxager 500 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2005-02-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA02" ], "active_substances": [ "Ciprofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/039/001", "product_name": "Xatger 10mg prolonged release tablets", "holder": "Viatris Limited", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA01" ], "active_substances": [ "Alfuzosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/040/001", "product_name": "Ondansetron 2 mg/ml Solution for Injection or Infusion", "holder": "Viatris Limited", "authorised_date": "2006-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "A04AA", "A04AA01" ], 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], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/042/004", "product_name": "Escitalpro 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2009-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/043/001", "product_name": "Azromax 250 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2010-06-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA10" ], "active_substances": [ "Azithromycin dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/044/001", "product_name": "Sevelamer Carbonate 800 mg film coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-11-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "V03AE", "V03AE02" ], "active_substances": [ "Sevelamer carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/045/001", "product_name": "Dutasteride/Tamsulosin hydrochloride 0.5 mg /0.4 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2019-12-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA", "G04CA52" ], "active_substances": [ "Dutasteride", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/046/001", "product_name": "Ciprager 10 mg Film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2003-06-03", "product_type": "HM", "market_status": "Marketed", 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"licence_number": "PA23266/046/003", "product_name": "Ciprager 40 mg Film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2004-07-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB04" ], "active_substances": [ "Citalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/047/001", "product_name": "Simvastatin 10 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2004-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/047/002", "product_name": "Simvastatin 20 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2004-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/047/003", "product_name": "Simvastatin 40 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2004-04-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/047/004", "product_name": "Simvastatin 80 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2004-04-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA01" ], "active_substances": [ "Simvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/048/001", "product_name": "Depreger 50 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2005-08-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/048/002", "product_name": "Depreger 100 mg film-coated tablet", "holder": "Viatris Limited", "authorised_date": "2005-08-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/049/001", "product_name": "Venlofex 75 mg prolonged-release hard capsules", "holder": "Viatris Limited", "authorised_date": "2008-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/049/002", "product_name": "Venlofex 150 mg prolonged-release hard capsules", "holder": "Viatris Limited", "authorised_date": "2008-10-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/050/001", "product_name": "Ezetimibe 10 mg tablets", "holder": "Viatris Limited", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AX", "C10AX09" ], "active_substances": [ "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/051/001", "product_name": "Sormon 60 mg Prolonged-release Tablets", "holder": "Viatris Limited", "authorised_date": "1999-08-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C01DA", "C01DA14" ], "active_substances": [ "Isosorbide-5-mononitrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/052/001", "product_name": "Tamoxifen 20 mg tablets", "holder": "Viatris Limited", "authorised_date": "1986-03-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02BA", "L02BA01" ], "active_substances": [ "Tamoxifen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/053/001", "product_name": "Atovaquone/Proguanil Hydrochloride 250 mg/100 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "P01BB", "P01BB51" ], "active_substances": [ "Atovaquone", "PROGUANIL HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/054/001", "product_name": "Etoricoxib 30 mg film-coated tablets", 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"M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/055/001", "product_name": "Bisoprolol Viatris 1.25 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-08-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/055/002", "product_name": "Bisoprolol Viatris 2.5 mg 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/055/006", "product_name": "Bisoprolol Viatris 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2011-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AB", "C07AB07" ], "active_substances": [ "BISOPROLOL FUMARATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/056/001", "product_name": "Abacavir/Lamivudine Viatris 600 mg/300 mg Film-coated Tablets", "holder": "Viatris Limited", "authorised_date": "2017-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AR", "J05AR02" ], "active_substances": [ "Abacavir sulfate", "Lamivudine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/058/001", "product_name": "Apixaban Viatris 2.5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-07-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/058/002", "product_name": "Apixaban Viatris 5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2021-07-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/062/001", "product_name": "Aripil 5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2008-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/062/002", "product_name": "Aripil 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2008-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06DA", "N06DA02" ], "active_substances": [ "Donepezil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/063/001", "product_name": "Tavager 500 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2009-03-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA12" ], "active_substances": [ "Levofloxacin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/064/001", "product_name": "Amisulpride 50 mg Tablets", "holder": "Viatris Limited", "authorised_date": "2014-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AL", "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/064/002", "product_name": "Amisulpride 200 mg Tablets", "holder": "Viatris Limited", "authorised_date": "2014-09-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AL", "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/068/001", "product_name": "Pemetrexed Viatris 25 mg/ml concentrate for solution for infusion", "holder": "Viatris Limited", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "L01BA", "L01BA04" ], "active_substances": [ "Pemetrexed" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/069/001", "product_name": "Apixaban Viatris Pharma 2.5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"atc_codes": [ "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/072/001", "product_name": "Apremilast Viatris 10 mg film-coated tablets Apremilast Viatris 20 mg film-coated tablets Apremilast Viatris 30 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2025-11-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/072/002", "product_name": "Apremilast Viatris 30 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2025-11-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/073/001", "product_name": "Rosuvastatin 5 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/073/002", "product_name": "Rosuvastatin 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/073/003", "product_name": "Rosuvastatin 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/073/004", "product_name": "Rosuvastatin 40 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/074/001", "product_name": "Razolager 15 mg hard gastro-resistant capsules", "holder": "Viatris Limited", "authorised_date": "2005-04-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/074/002", "product_name": "Razolager 30 mg hard gastro-resistant capsules", "holder": "Viatris Limited", "authorised_date": "2005-04-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC03" ], "active_substances": [ "Lansoprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/075/001", "product_name": "Agerdex 1 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2007-11-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/076/001", "product_name": "Geroquel 25 mg 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(A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/076/003", "product_name": "Geroquel 200 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2007-10-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/077/001", "product_name": "Omeprazole 10 mg Gastro-resistant Capsules, hard", "holder": "Viatris Limited", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/077/002", "product_name": "Omeprazole 20 mg Gastro-resistant Capsules, hard", "holder": "Viatris Limited", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/077/003", "product_name": "Omeprazole 40 mg Gastro-resistant Capsules, hard", "holder": "Viatris Limited", "authorised_date": "2017-02-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/078/001", "product_name": "Olmesartan medoxomil 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/078/002", "product_name": "Olmesartan medoxomil 20 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/078/003", "product_name": "Olmesartan medoxomil 40 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2015-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA08" ], "active_substances": [ "Olmesartan medoxomil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/080/001", "product_name": "Ejulir 6 mg/ml solution for injection in pre-filled pen", "holder": "Viatris Limited", "authorised_date": "2026-02-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "A10BJ02" ], "active_substances": [ "Liraglutide" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/081/001", "product_name": "Lenvatinib Viatris 4 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX08" ], "active_substances": [ "Lenvatinib besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/081/002", "product_name": "Lenvatinib Viatris 10 mg hard capsules", "holder": "Viatris Limited", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EX08" ], "active_substances": [ "Lenvatinib besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23266/082/001", "product_name": "Avarante 10 mg film-coated tablets", "holder": "Viatris Limited", "authorised_date": "2026-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23271/001/001", "product_name": "Atorvastatin OPKO 40 mg film coated tablets", "holder": "Opko Health Spain S.L.U.", "authorised_date": "2023-06-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA05" ], "active_substances": [ "Atorvastatin calcium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23289/002/001", "product_name": "Ditagfenda 120 mg hard gastro-resistant capsules", "holder": "Adalvo Limited", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23289/002/002", "product_name": "Ditagfenda 240 mg hard gastro-resistant capsules", "holder": "Adalvo Limited", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "L04AX07" ], "active_substances": [ "Dimethyl Fumarate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/001/001", "product_name": "Fortum 500 mg powder for solution for injection", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1984-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/001/002", "product_name": "Fortum 1 g powder for solution for injection or infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1984-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/001/003", "product_name": "Fortum 2 g powder for solution for injection or infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1984-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD02" ], "active_substances": [ "Ceftazidime" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/002/001", "product_name": "Zinacef 250 mg powder for solution for injection or infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1978-08-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/002/002", "product_name": "Zinacef 750 mg powder for solution for injection or infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1978-08-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/002/003", "product_name": "Zinacef 1.5 g powder for solution for injection or infusion", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1978-08-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime Sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/003/001", "product_name": "Zinnat 250mg/5ml granules for oral suspension", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1998-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime axetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/003/002", "product_name": "Zinnat 125 mg film-coated tablets", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1989-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/003/003", "product_name": "Zinnat 250 mg film-coated tablets", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1989-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/003/004", "product_name": "Zinnat 500 mg film-coated tablets", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1989-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/003/005", "product_name": "Zinnat 125 mg/5 ml granules for oral suspension", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1991-01-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01DC", "J01DC02" ], "active_substances": [ "Cefuroxime axetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/004/001", "product_name": "Estradot 37.5 micrograms/24 hours, transdermal patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/004/002", "product_name": "Estradot 50 micrograms/24 hours, transdermal patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/004/003", "product_name": "Estradot 75 micrograms/24 hours, transdermal patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/004/004", "product_name": "Estradot 100 micrograms/24 hours, transdermal patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/004/005", "product_name": "Estradot 25 micrograms/24 hours, transdermal patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "2005-05-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/005/001", "product_name": "Transiderm-Nitro 5milligrams/24 hours Transdermal Patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1985-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/005/002", "product_name": "Transiderm-Nitro 10milligram/24 hours Transdermal Patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1985-04-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23311/005/003", "product_name": "Transiderm-Nitro 15milligrams/24 hours Transdermal Patch", "holder": "Sandoz Pharmaceuticals d.d.", "authorised_date": "1995-01-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "C01DA", "C01DA02" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23312/001/001", "product_name": "Egostar 22400 IU film-coated tablets", "holder": "Jaba Recordati S.A.", "authorised_date": "2022-04-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A11CC05" ], "active_substances": [ "Vitamin d3" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23314/001/001", "product_name": "Xilmac 4 mg/ml Solution for injection", "holder": "Macure Healthcare Limited", "authorised_date": "1977-06-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N05BA", "N05BA06" ], "active_substances": [ "Lorazepam" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23314/002/001", "product_name": "Labrycor 0.2 mg/ml concentrate for solution for infusion", "holder": "Macure Healthcare Limited", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C01CA02" ], "active_substances": [ "Isoprenaline hydrochloride" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23317/001/001", "product_name": "Cyclolux 0.5 mmol/ml solution for injection", "holder": "Sanochemia Pharmazeutika GmbH", "authorised_date": "2022-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V08CA02" ], "active_substances": [ "Gadoteric acid" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23335/001/001", "product_name": "Dexeta 1.37 mg/ml eye drops, solution in single dose container", "holder": "SIFI S.p.A.", "authorised_date": "2020-11-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01BA01" ], "active_substances": [ "Dexamethasone sodium phosphate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23337/001/001", "product_name": "Colchicine Indoco 500 microgram tablets", "holder": "Indoco Remedies Czech s.r.o.", "authorised_date": "2024-12-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M04AC01" ], "active_substances": [ "Colchicine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/001/001", "product_name": "Hydrocortisone Hualan 2.5 mg tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/001/002", "product_name": "Hydrocortisone Hualan 5 mg tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/001/003", "product_name": "Hydrocortisone Hualan 10 mg tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/001/004", "product_name": "Hydrocortisone Hualan 15 mg tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/001/005", "product_name": "Hydrocortisone Hualan 20 mg tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AB09" ], "active_substances": [ "Hydrocortisone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/002/001", "product_name": "Ibuprofen 200mg Film-coated tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/002/002", "product_name": "Ibuprofen 400mg Film-coated Tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Not applicable", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/002/003", "product_name": "Ibuprofen 600mg Film-coated Tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Not applicable", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/006/001", "product_name": "Amlodipine 2.5 mg Tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/006/002", "product_name": "Amlodipine 5 mg Tablet", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/006/003", "product_name": "Amlodipine 7.5 mg Tablet", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23341/006/004", "product_name": "Amlodipine 10 mg Tablets", "holder": "Hualan Pharmaceuticals Limited", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23343/001/001", "product_name": "Dnord 255 microgram soft capsules", "holder": "Nordic Pharma Limited", "authorised_date": "2022-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC06" ], "active_substances": [ "Calcifediol monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23354/001/001", "product_name": "Brevoxyl 40 mg/g cream", "holder": "Avianta Pharma EU Limited", "authorised_date": "1995-11-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AE", "D10AE01" ], "active_substances": [ "Benzoyl Peroxide" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/001/001", "product_name": "Cardura XL 4 mg Prolonged-release tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1999-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/001/002", "product_name": "Cardura XL 8 mg Prolonged-release tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1999-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/002/001", "product_name": "Efexor XL 37.5 mg prolonged-release capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "1999-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/002/002", "product_name": "Efexor XL 75 mg prolonged-release capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "1999-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/002/003", "product_name": "Efexor XL 150 mg prolonged-release capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "1999-07-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/003/001", "product_name": "CARDURA 1mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1987-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/003/002", "product_name": "CARDURA 2mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1987-12-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C02CA", "C02CA04" ], "active_substances": [ "Doxazosin mesilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/005/001", "product_name": "Regurin 20 mg coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2001-05-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G04BD", "G04BD09" ], "active_substances": [ "Trospium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/006/001", "product_name": "Creon 10000 Gastro-resistant Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-03-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/006/002", "product_name": "Creon 25000 Gastro-resistant Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-04-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/006/003", "product_name": "Creon for Children 5000 Gastro-resistant Granules", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant granules", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/006/004", "product_name": "Creon 20000 Gastro-resistant Capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/006/005", "product_name": "Creon 35000 Gastro-resistant Capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/007/001", "product_name": "Molaxole powder for oral solution", "holder": "Viatris Healthcare Limited", "authorised_date": "2009-12-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/009/001", "product_name": "Desunin 800 IU Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2012-06-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A11CC", "A11CC05" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/009/002", "product_name": "Desunin 1000 IU Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2015-12-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A11C" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/009/003", "product_name": "Desunin 2000 IU Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2015-12-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A11C" ], "active_substances": [ "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/009/004", "product_name": "Desunin 4000 IU Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2015-12-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A11C" ], "active_substances": [ "Colecalciferol concentrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/010/001", "product_name": "Dymista 137 micrograms/50 micrograms per actuation, Nasal Spray Suspension", "holder": "Viatris Healthcare Limited", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD58" ], "active_substances": [ "Azelastine hydrochloride", "Fluticasone propionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/011/001", "product_name": "EpiPen Junior 150 micrograms solution for injection in pre-filled pen", "holder": "Viatris Healthcare Limited", "authorised_date": "2013-08-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Adrenaline" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/011/002", "product_name": "EpiPen 300 micrograms solution for injection in pre-filled pen", "holder": "Viatris Healthcare Limited", "authorised_date": "2013-08-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C01CA", "C01CA24" ], "active_substances": [ "Adrenaline" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/012/001", "product_name": "Brufen 400mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1975-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/012/002", "product_name": "Brufen 600mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1982-06-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/012/003", "product_name": "Brufen Paediatric 100 mg/5 ml Oral Suspension", "holder": "Viatris Healthcare Limited", "authorised_date": "1981-03-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/012/004", "product_name": "Brufen Retard 800mg prolonged release tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1990-01-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/013/001", "product_name": "Klacid 250 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1989-11-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/013/002", "product_name": "Klacid Forte 500 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1995-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/013/003", "product_name": "Klacid IV 500mg Powder for Concentrate for Solution for Infusion", "holder": "Viatris Healthcare Limited", "authorised_date": "1994-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Intravenous use", "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/013/004", "product_name": "Klacid LA 500mg Modified release tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-03-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/013/005", "product_name": "Klacid Paediatric Suspension 125 mg/5 ml, Granules for Oral Suspension", "holder": "Viatris Healthcare Limited", "authorised_date": "1996-11-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/013/006", "product_name": "Klacid 250 mg/5 ml Granules for Oral Suspension", "holder": "Viatris Healthcare Limited", "authorised_date": "1998-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Granules for oral suspension", "atc_codes": [ "J01FA", "J01FA09" ], "active_substances": [ "Clarithromycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/014/001", "product_name": "Serc 8mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA01" ], "active_substances": [ "Betahistine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/014/002", "product_name": "Serc 16mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1990-10-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA01" ], "active_substances": [ "Betahistine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/016/001", "product_name": "Influvac Tetra, suspension for injection in pre-filled syringe (influenza vaccine, surface antigen, inactivated)", "holder": "Viatris Healthcare Limited", "authorised_date": "2017-08-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB", "J07BB02" ], "active_substances": [ "B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)", "Influenza A virus, subtype H1N1, strain A/Missouri/11/2025 pdm09-like strain (A/Switzerland/6849/2025, IVR-278), Inactivated", "Influenza A virus, subtype H3N2, strain A/Darwin/1454/2025-like strain (A/Michigan/105/2025, SAN-049A), Inactivated", "Influenza B virus, strain B/Tokyo/EIS13-175/2025-like strain (B/Tokyo/EIS13-175/2025, wild type), Inactivated" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/017/001", "product_name": "Zimovane 7.5 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CF", "N05CF01" ], "active_substances": [ "Zopiclone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/018/001", "product_name": "Isoptin 40 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08DA", "C08DA01" ], "active_substances": [ "Verapamil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/018/002", "product_name": "Isoptin 80 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08DA", "C08DA01" ], "active_substances": [ "Verapamil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/018/003", "product_name": "Isoptin 2.5 mg/ml Solution for Injection or Infusion", "holder": "Viatris Healthcare Limited", "authorised_date": "1980-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C08DA", "C08DA01" ], "active_substances": [ "Verapamil hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/018/004", "product_name": "Isoptin SR 240 mg Prolonged-Release Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1987-05-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08DA", "C08DA01" ], "active_substances": [ "Verapamil hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/019/001", "product_name": "Colofac 135 mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1983-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "A03AA", "A03AA04" ], "active_substances": [ "Mebeverine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/020/001", "product_name": "TEVETEN 400 mg, film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA02" ], "active_substances": [ "Eprosartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/020/002", "product_name": "Teveten 600 mg, film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA02" ], "active_substances": [ "Eprosartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/021/001", "product_name": "Teveten Plus 600 mg/12.5 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2005-01-28", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA02" ], "active_substances": [ "Eprosartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/022/001", "product_name": "Clozaril 25 mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1992-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/022/002", "product_name": "Clozaril 100 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1992-05-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH", "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/022/003", "product_name": "Clozaril 200 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/022/004", "product_name": "Clozaril 12.5 mg orodispersible tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/022/005", "product_name": "Clozaril 25 mg orodispersible tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/022/006", "product_name": "Clozaril 100 mg orodispersible tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2025-04-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N05AH02" ], "active_substances": [ "Clozapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/023/001", "product_name": "Tambocor 10 mg/ml Solution for Injection or Infusion", "holder": "Viatris Healthcare Limited", "authorised_date": "1984-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "C01BC", "C01BC04" ], "active_substances": [ "Flecainide acetate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/023/002", "product_name": "Tambocor 50 mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1999-10-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BC", "C01BC04" ], "active_substances": [ "Flecainide acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/023/003", "product_name": "Tambocor 100 mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1984-12-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BC", "C01BC04" ], "active_substances": [ "Flecainide acetate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/024/001", "product_name": "Faverin 50 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1989-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB08" ], "active_substances": [ "Fluvoxamine maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/024/002", "product_name": "Faverin 100 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1989-10-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB08" ], "active_substances": [ "Fluvoxamine maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/025/001", "product_name": "Dalmane 15 mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05CD", "N05CD01" ], "active_substances": [ "Flurazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/025/002", "product_name": "Dalmane 30 mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05CD", "N05CD01" ], "active_substances": [ "Flurazepam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/026/001", "product_name": "Efudix 5 % w/w Cream", "holder": "Viatris Healthcare Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "L01BC", "L01BC02" ], "active_substances": [ "Fluorouracil" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23355/027/001", "product_name": "Mestinon 60mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07AA", "N07AA02" ], "active_substances": [ "Pyridostigmine bromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/028/001", "product_name": "Minocin SA 100 mg Modified Release Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1993-06-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "J01AA", "J01AA08" ], "active_substances": [ "Minocycline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/029/001", "product_name": "Epipen Evo 300 microgram solution for injection in pre-filled pen", "holder": "Viatris Healthcare Limited", "authorised_date": "2026-07-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C01CA24" ], "active_substances": [ "Adrenaline tartrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/029/002", "product_name": "Epipen Evo Junior 150 microgram solution for injection in pre-filled pen", "holder": "Viatris Healthcare Limited", "authorised_date": "2026-07-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "C01CA24" ], "active_substances": [ "Adrenaline tartrate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/031/001", "product_name": "Influvac sub-unit, suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated)", "holder": "Viatris Healthcare Limited", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "Influenza A virus, subtype H3N2, strain A/Darwin/1454/2025-like strain (A/Michigan/105/2025, SAN-049A), Inactivated", "Influenza B virus, strain B/Tokyo/EIS13-175/2025-like strain (B/Tokyo/EIS13-175/2025, wild type), Inactivated", "Influenza A virus, subtype H1N1, strain A/Missouri/11/2025 pdm09-like strain (A/Missouri/11/2025, IVR-279), Inactivated" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/032/001", "product_name": "Librium 5mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05BA", "N05BA02" ], "active_substances": [ "CHLORDIAZEPOXIDE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/032/002", "product_name": "Librium 10mg Hard Capsule", "holder": "Viatris Healthcare Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05BA", "N05BA02" ], "active_substances": [ "CHLORDIAZEPOXIDE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/033/001", "product_name": "Spasmonal 60mg hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1993-10-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A03AX", "A03AX08" ], "active_substances": [ "ALVERINE CITRATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/034/001", "product_name": "Treclin 10 mg/g + 0.25 mg/g Gel", "holder": "Viatris Healthcare Limited", "authorised_date": "2013-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AF", "D10AF01" ], "active_substances": [ "Clindamycin", "Tretinoin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/035/001", "product_name": "Cyklokapron 500 mg Film-coated Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02AA", "B02AA02" ], "active_substances": [ "TRANEXAMIC ACID PH. EUR." ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/036/001", "product_name": "Fludrocortisone acetate 0.1 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H02AA", "H02AA02" ], "active_substances": [ "Fludrocortisone acetate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/037/001", "product_name": "Odrik 1mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1992-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C09AA", "C09AA10" ], "active_substances": [ "Trandolapril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/037/002", "product_name": "Odrik 2mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1992-11-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C09AA", "C09AA10" ], "active_substances": [ "Trandolapril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/038/001", "product_name": "Fematab 2mg Film-coated tablet", "holder": "Viatris Healthcare Limited", "authorised_date": "1994-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/039/001", "product_name": "Relifex 500 mg film-coated Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1984-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX01" ], "active_substances": [ "Nabumetone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/039/002", "product_name": "Relifex 1g film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2009-10-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AX", "M01AX01" ], "active_substances": [ "Nabumetone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/041/001", "product_name": "Azecort 137 micrograms/50 micrograms per actuation nasal spray, suspension", "holder": "Viatris Healthcare Limited", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD58" ], "active_substances": [ "Azelastine hydrochloride", "Fluticasone propionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Fixed combination application (Article 10b of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/042/001", "product_name": "Lipantil Micro 67 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10AB", "C10AB05" ], "active_substances": [ "Fenofibrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/042/002", "product_name": "Lipantil Micro 200 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1998-07-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C10AB", "C10AB05" ], "active_substances": [ "Fenofibrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/042/003", "product_name": "Lipantil Supra 145mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2005-07-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AB", "C10AB05" ], "active_substances": [ "Fenofibrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/042/004", "product_name": "Lipantil Supra 215 mg, film-coated tablet", "holder": "Viatris Healthcare Limited", "authorised_date": "2005-03-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AB", "C10AB05" ], "active_substances": [ "Fenofibrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/043/001", "product_name": "Manerix 150 mg Film-coated Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1991-07-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AG", "N06AG02" ], "active_substances": [ "Moclobemide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/045/001", "product_name": "TOBI 300 mg/5 mL Nebuliser Solution", "holder": "Viatris Healthcare Limited", "authorised_date": "2000-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "J01GB", "J01GB01" ], "active_substances": [ "Tobramycin" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/046/001", "product_name": "Orgaran 750 anti-Xa units/0.6ml Solution for injection", "holder": "Viatris Healthcare Limited", "authorised_date": "1993-10-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB09" ], "active_substances": [ "Danaparoid sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23355/047/001", "product_name": "Lipitor 10 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/002", "product_name": "Lipitor 20 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/003", "product_name": "Lipitor 40 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/004", "product_name": "Lipitor 80 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/005", "product_name": "Lipitor 5 mg chewable tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/006", "product_name": "Lipitor 10 mg chewable tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/007", "product_name": "Lipitor 20 mg chewable tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/047/008", "product_name": "Lipitor 40 mg chewable tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/048/001", "product_name": "Lustral 50 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1991-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/048/002", "product_name": "Lustral 100 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1991-08-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/049/001", "product_name": "RELPAX 40 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2001-11-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC06" ], "active_substances": [ "ELETRIPTAN" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/001", "product_name": "Epanutin 25 mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1976-10-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "PHENYTOIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/002", "product_name": "Epanutin 50 mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "PHENYTOIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/003", "product_name": "Epanutin 100 mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "PHENYTOIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/004", "product_name": "Epanutin 300 mg Hard Capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "1990-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "PHENYTOIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/005", "product_name": "Epanutin Infatabs 50mg Chewable Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1975-05-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "Phenytoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/006", "product_name": "Epanutin Ready Mixed Parenteral 250 mg/5 ml Solution for Injection or Infusion", "holder": "Viatris Healthcare Limited", "authorised_date": "1975-05-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "PHENYTOIN SODIUM" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/050/007", "product_name": "Epanutin 30 mg/5ml Oral Suspension", "holder": "Viatris Healthcare Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "Phenytoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/051/001", "product_name": "Neurontin 100 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/051/002", "product_name": "Neurontin 300 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/051/003", "product_name": "Neurontin 400 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/051/004", "product_name": "Neurontin 600 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/051/005", "product_name": "Neurontin 800 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2006-02-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BF01" ], "active_substances": [ "Gabapentin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/052/001", "product_name": "INSPRA 25 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2004-08-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/052/002", "product_name": "INSPRA 50 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2004-08-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA", "C03DA04" ], "active_substances": [ "Eplerenone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/053/001", "product_name": "Celebrex 100 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "2000-05-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AH", "M01AH01" ], "active_substances": [ "Celecoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/053/002", "product_name": "Celebrex 200 mg hard capsules", "holder": "Viatris Healthcare Limited", "authorised_date": "2000-05-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AH", "M01AH01" ], "active_substances": [ "Celecoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/054/001", "product_name": "Detrusitol SR 2 mg prolonged-release capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2001-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/054/002", "product_name": "Detrusitol SR 4 mg prolonged-release capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2001-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/056/001", "product_name": "Xalacom 50 micrograms/mL + 5 mg/mL, eye drops, solution", "holder": "Viatris Healthcare Limited", "authorised_date": "2001-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Latanoprost", "Timolol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/057/001", "product_name": "Xalatan 50 micrograms/mL Eye drops, solution", "holder": "Viatris Healthcare Limited", "authorised_date": "1997-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EE", "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/058/001", "product_name": "Xanax 1 mg Tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1982-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/058/002", "product_name": "Xanax 250 microgram tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1982-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/058/003", "product_name": "Xanax 500 microgram tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1982-11-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N05BA", "N05BA12" ], "active_substances": [ "Alprazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/059/001", "product_name": "Istin 5 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1989-08-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/059/002", "product_name": "Istin 10 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1989-08-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/059/003", "product_name": "Istin 5 mg hard capsule", "holder": "Viatris Healthcare Limited", "authorised_date": "2019-01-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/059/004", "product_name": "Istin 10 mg hard capsule", "holder": "Viatris Healthcare Limited", "authorised_date": "2019-01-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/060/001", "product_name": "Amlodipine Upjohn 5 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2011-12-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/060/002", "product_name": "Amlodipine Upjohn 10 mg tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "2011-12-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/061/001", "product_name": "Detrusitol 1 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1998-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/061/002", "product_name": "Detrusitol 2 mg film-coated tablets", "holder": "Viatris Healthcare Limited", "authorised_date": "1998-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD07" ], "active_substances": [ "Tolterodine tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/062/001", "product_name": "Geodon 20mg capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05AE", "N05AE04" ], "active_substances": [ "Ziprasidone hydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/062/002", "product_name": "Geodon 40mg capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05AE", "N05AE04" ], "active_substances": [ "Ziprasidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/062/003", "product_name": "Geodon 60mg capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05AE", "N05AE04" ], "active_substances": [ "Ziprasidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/062/004", "product_name": "Geodon 80mg capsules, hard", "holder": "Viatris Healthcare Limited", "authorised_date": "2002-03-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N05AE", "N05AE04" ], "active_substances": [ "Ziprasidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/063/001", "product_name": "Viagra Connect 50 mg Film-Coated Tablet", "holder": "Viatris Healthcare Limited", "authorised_date": "2019-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23355/063/002", "product_name": "Viagra Connect 50 mg orodispersible films", "holder": "Viatris Healthcare Limited", "authorised_date": "2025-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible film", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23368/001/001", "product_name": "Terbza 98 mg/ml cutaneous solution", "holder": "Moberg Pharma AB (publ)", "authorised_date": "2023-07-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D01AE15" ], "active_substances": [ "Terbinafine hydrochloride" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23369/001/001", "product_name": "PHYLLOCONTIN 225 mg Prolonged Release Tablets", "holder": "Ennogen Healthcare (Europe) Limited", "authorised_date": "1984-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "R03DA", "R03DA05" ], "active_substances": [ "Aminophylline hydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23369/003/001", "product_name": "UNIPHYLLIN 200 mg Prolonged-Release Tablets", "holder": "Ennogen Healthcare (Europe) Limited", "authorised_date": "1983-02-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "R03DA", "R03DA04" ], "active_substances": [ "Theophylline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23369/003/002", "product_name": "UNIPHYLLIN 300 mg Prolonged-Release Tablets", "holder": "Ennogen Healthcare (Europe) Limited", "authorised_date": "1989-03-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "R03DA", "R03DA04" ], "active_substances": [ "Theophylline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23369/003/003", "product_name": "UNIPHYLLIN 400 mg Prolonged-Release Tablets", "holder": "Ennogen Healthcare (Europe) Limited", "authorised_date": "1983-06-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "R03DA", "R03DA04" ], "active_substances": [ "Theophylline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23369/004/001", "product_name": "Axsain 0.075% w/w Cream", "holder": "Ennogen Healthcare (Europe) Limited", "authorised_date": "2010-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "M02AB01" ], "active_substances": [ "Capsaicin" ], "routes": [ "Topical" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23369/005/001", "product_name": "Zacin 0.025% w/w Cream", "holder": "Ennogen Healthcare (Europe) Limited", "authorised_date": "2010-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "M02AB" ], "active_substances": [ "Capsaicin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23382/002/001", "product_name": "Kacital 1080 mg modified-release tablets", "holder": "XGX Pharma ApS", "authorised_date": "2024-08-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "A12BA02" ], "active_substances": [ "Potassium citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23405/002/001", "product_name": "Apixaban Abdi 2.5 mg film-coated tablet", "holder": "Abdi Farma GmbH", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23405/002/002", "product_name": "Apixaban Abdi 5 mg film-coated tablet", "holder": "Abdi Farma GmbH", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF02" ], "active_substances": [ "Apixaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23405/003/001", "product_name": "Naproxen/Esomeprazole Abdi 500 mg/20 mg Modified Release Tablets", "holder": "Abdi Farma GmbH", "authorised_date": "2024-11-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AE52" ], "active_substances": [ "Naproxen", "Esomeprazole magnesium trihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23405/004/001", "product_name": "Macitentan Abdi 10 mg film-coated tablets", "holder": "Abdi Farma GmbH", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C02KX04" ], "active_substances": [ "Macitentan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23409/001/001", "product_name": "Verdye 5 mg/ml powder for solution for injection", "holder": "Diagnostic Green Limited", "authorised_date": "2022-06-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "V04CX" ], "active_substances": [ "Indocyanine green" ], "routes": [ "Intravenous use", "Peritumoral use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23425/001/001", "product_name": "Fusidic acid/Betamethasone Galenpharma 20+1mg/gram(s) Cream", "holder": "GALENpharma GmbH", "authorised_date": "2024-07-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC01" ], "active_substances": [ "Fusidic acid", "Betamethasone valerate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/001/001", "product_name": "Lacosamide Ascend 10 mg/ml syrup", "holder": "Ascend GmbH", "authorised_date": "2024-05-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N03AX18" ], "active_substances": [ "Lacosamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/002/001", "product_name": "Sitagliptin and Metformin hydrochloride Ascend 50 mg/850 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin Hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/002/002", "product_name": "Sitagliptin and Metformin hydrochloride Ascend 50 mg/1000 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A10BD07" ], "active_substances": [ "Sitagliptin phosphate", "Metformin 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"authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA03" ], "active_substances": [ "Varenicline tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/004/002", "product_name": "Varenicline Ascend 1 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-01-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA03" ], "active_substances": [ "Varenicline tartrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "", "legal_basis": "Generic application (Article 10(1) of 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"routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/007/001", "product_name": "Rivaroxaban Ascend 2.5 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/007/002", "product_name": "Rivaroxaban Ascend 10 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/007/003", "product_name": "Rivaroxaban Ascend 15 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/007/004", "product_name": "Rivaroxaban Ascend 20 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/007/005", "product_name": "Rivaroxaban Ascend 15 mg film-coated tablets Rivaroxaban Ascend 20 mg film-coated tablets", "holder": "Ascend GmbH", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23429/008/001", "product_name": "Fosfomycin Ascend 3 g granules for oral solution", "holder": "Ascend GmbH", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "J01XX01" ], "active_substances": [ "Fosfomycin trometamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23431/001/001", "product_name": "Meropenem 500 mg powder 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"Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23438/002/001", "product_name": "Pirfenidone nio 267 mg film-coated tablets", "holder": "Axunio Pharma GmbH", "authorised_date": "2023-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23438/002/002", "product_name": "Pirfenidone nio 534 mg film-coated tablets", "holder": "Axunio Pharma GmbH", "authorised_date": "2023-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23438/002/003", "product_name": "Pirfenidone nio 801 mg film-coated tablets", "holder": "Axunio Pharma GmbH", "authorised_date": "2023-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX05" ], "active_substances": [ "Pirfenidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23449/001/001", "product_name": "Nitisinone Dipharma 5 mg hard capsules", "holder": "Dipharma Arzneimittel GmbH", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23449/001/002", "product_name": "Nitisinone Dipharma 10 mg hard capsules", "holder": "Dipharma Arzneimittel GmbH", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23449/001/003", "product_name": "Nitisinone Dipharma 2 mg hard capsules", "holder": "Dipharma Arzneimittel GmbH", "authorised_date": "2020-05-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23449/001/004", "product_name": "Nitisinone Dipharma 20 mg hard capsules", "holder": "Dipharma Arzneimittel GmbH", "authorised_date": "2020-05-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A16AX04" ], "active_substances": [ "Nitisinone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23450/001/001", "product_name": "Eribulin Advanz Pharma 0.44 mg/ml solution for injection", "holder": "Advanz Pharma Limited", "authorised_date": "2023-09-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX41" ], "active_substances": [ "Eribulin mesylate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23450/002/001", "product_name": "Tostran 20 mg/g transdermal gel", "holder": "Advanz Pharma Limited", "authorised_date": "2006-08-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal gel", "atc_codes": [ "G03BA", "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23450/003/001", "product_name": "Adaluzis 500mg Powder for concentrate for solution for infusion", "holder": "Advanz Pharma Limited", "authorised_date": "2017-09-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for concentrate for solution for infusion", "atc_codes": [ "J01DI", "J01DI01" ], "active_substances": [ "Ceftobiprole medocaril sodium" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23450/004/001", "product_name": "Androcur 100 mg tablets", "holder": "Advanz Pharma Limited", "authorised_date": "1997-01-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03HA01" ], "active_substances": [ "Cyproterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23451/001/001", "product_name": "Meropenem ACS Dobfar 500 mg powder for solution for injection/infusion", "holder": "ACS Dobfar S.p.A.", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH02" ], "active_substances": [ "Meropenem" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23451/001/002", "product_name": "Meropenem ACS Dobfar 1 g powder for solution for injection/infusion", "holder": "ACS Dobfar S.p.A.", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH02" ], "active_substances": [ "Meropenem" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23451/001/003", "product_name": "Meropenem ACS Dobfar 2 g powder for solution for injection/infusion", "holder": "ACS Dobfar S.p.A.", "authorised_date": "2026-06-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH02" ], "active_substances": [ "Meropenem Trihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/001/001", "product_name": "Efluelda suspension for injection in pre-filled syringe Trivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2024-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "Influenza A virus, subtype H1N1, strain A/Missouri/11/2025 pdm09-like strain (A/Switzerland/6849/2025, IVR-278), Inactivated", "Influenza A virus, subtype H3N2, strain A/Darwin/1454/2025-like strain (A/Michigan/105/2025, SAN-049A), Inactivated", "Influenza B virus, strain B/Tokyo/EIS13-175/2025-like strain (B/Tokyo/EIS13-175/2025, wild type), Inactivated" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/002/001", "product_name": "Vaxigrip suspension for injection in pre-filled syringe.Trivalent influenza vaccine (split virion, inactivated).", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2024-12-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "Influenza A virus, subtype H1N1, strain A/Missouri/11/2025 pdm09-like strain (A/Switzerland/6849/2025, IVR-278), Inactivated", "Influenza A virus, subtype H3N2, strain A/Darwin/1454/2025-like strain (A/Michigan/105/2025, SAN-049A), Inactivated", "Influenza B virus, strain B/Tokyo/EIS13-175/2025-like strain (B/Tokyo/EIS13-175/2025, wild type), Inactivated" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription 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Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content)", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2003-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07CA", "J07CA02" ], "active_substances": [ "Tetanus toxoid", "Diphtheria toxoid", "Pertussis toxoid", "Filamentous haemagglutinin", "Pertactin", "Polio virus type 1 inactivated", "Polio virus type 2 inactivated", "Polio virus type 3 inactivated", "Adsorbed aluminium phosphate", "Adsorbed fimbriae types 2 + 3" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/005/001", "product_name": "REVAXIS Suspension for injection in pre-filled syringe Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2000-02-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07CA01" ], "active_substances": [ "Diphtheria toxoid", "Tetanus toxoid", "POLIOVIRUS, TYPE 1", "Poliovirus, type 2", "Poliovirus, type 3" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/006/001", "product_name": "STAMARIL, powder and solvent for suspension for injection in pre-filled syringe. Yellow fever vaccine (Live)", "holder": "Sanofi Winthrop Industrie", "authorised_date": "1999-09-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection in pre-filled syringe", "atc_codes": [ "J07BL", "J07BL01" ], "active_substances": [ "Yellow fever virus 17 d-204 strain" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/007/001", "product_name": "Tetravac, suspension for injection in prefilled syringe Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine, (adsorbed).", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2001-03-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07CA", "J07CA02" ], "active_substances": [ "Adsorbed purified pertussis toxoid", "Adsorbed purified filamentous haemagglutinin", "Purified tetanus toxoid", "Purified diphtheria toxoid ph. eur.", "Inactivated type 1 poliovirus", "Inactivated type 2 poliovirus", "Inactivated type 3 poliovirus" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/008/001", "product_name": "Triaxis, suspension for injection in a pre-filled syringe Diphtheria, Tetanus, Pertussis (acellular component) Vaccine (adsorbed, reduced antigen(s) content)", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2016-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07AJ", "J07AJ52" ], "active_substances": [ "Diphtheria toxoid", "Tetanus toxoid", "Pertussis toxoid", "Filamentous haemagglutinin", "Pertactin (prn)", "Fimbriae types 2 and 3" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/009/001", "product_name": "Typhim Vi Solution for Injection Typhoid Polysaccharide Vaccine", "holder": "Sanofi Winthrop Industrie", "authorised_date": "1992-08-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "J07AP03" ], "active_substances": [ "Salmonella typhi, vi antigen" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/010/001", "product_name": "Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated)", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2016-07-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB", "J07BB02" ], "active_substances": [ "A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238", "B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type)", "B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)", "Influenza A virus, A/Croatia/10136RV/2023 (H3N2) like strain X-425A, Inactivated" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/011/001", "product_name": "Verorab, powder and solvent for suspension for injection. Rabies vaccine, inactivated.", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2023-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection in pre-filled syringe", "atc_codes": [ "J07BG01" ], "active_substances": [ "Rabies virus (inactivated) strain wistar (PM/WI 38-1503-3M)" ], "routes": [ "Intradermal use", "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23458/012/001", "product_name": "Efluelda Tetra, suspension for injection in pre-filled syringe", "holder": "Sanofi Winthrop Industrie", "authorised_date": "2020-04-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Suspension for injection in pre-filled syringe", "atc_codes": [ "J07BB02" ], "active_substances": [ "Influenza Inactivated Split Virus Strain B", "Influenza Inactivated Split Virus Strain A (H3N2)", "Influenza Inactivated Split Virus Strain B", "Influenza Inactivated Split Virus Strain A (H1N1)" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23460/001/001", "product_name": "Temgesic 200 microgram Sublingual Tablets", "holder": "Eumedica Pharmaceuticals GmbH", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Sublingual tablet", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23460/001/002", "product_name": "Temgesic 300 micrograms/ml, solution for injection", "holder": "Eumedica Pharmaceuticals GmbH", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N02AE", "N02AE01" ], "active_substances": [ "Buprenorphine hydrochloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23460/002/001", "product_name": "Negaban 1 g powder for solution for injection/infusion", "holder": "Eumedica Pharmaceuticals GmbH", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CA17" ], "active_substances": [ "Temocillin disodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23460/002/002", "product_name": "Negaban 2 g powder for solution for injection/infusion", "holder": "Eumedica Pharmaceuticals GmbH", "authorised_date": "2026-02-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CA17" ], "active_substances": [ "Temocillin sodium" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23467/001/001", "product_name": "Piperacillin/Tazobactam Aurobindo 2 g/0.25 g powder for solution for infusion", "holder": "Eugia Pharma (Malta) Limited", "authorised_date": "2010-02-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23467/001/002", "product_name": "Piperacillin/Tazobactam Aurobindo 4 g/0.5 g powder for solution for infusion", "holder": "Eugia Pharma (Malta) Limited", "authorised_date": "2010-02-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J01CR", "J01CR05" ], "active_substances": [ "Piperacillin", "Tazobactam" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23467/002/001", "product_name": "Meropenem Aurobindo 500mg Powder for solution for injection or infusion", "holder": "Eugia Pharma (Malta) Limited", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem trihydrate (sterile)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23467/002/002", "product_name": "Meropenem Aurobindo 1g Powder for solution for injection or infusion", "holder": "Eugia Pharma (Malta) Limited", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DH", "J01DH02" ], "active_substances": [ "Meropenem trihydrate (sterile)" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23487/002/001", "product_name": "Hezkue 12.5 mg/actuation, oral suspension", "holder": "Aspargo Labs Italia S.r.l.", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "G04BE03" ], "active_substances": [ "Sildenafil citrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/001/001", "product_name": "Neutrogena T/Gel Shampoo 5 mg/ml", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1987-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Shampoo", "atc_codes": [ "D05AA" ], "active_substances": [ "Coal tar" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/002/001", "product_name": "Benylin Dual Action Dry Syrup, Pseudoephedrine 30mg, Dextromethorphan 10mg, Triprolidine 1.25mg", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2004-03-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R01BA", "R01BA52" ], "active_substances": [ "Dextromethorphan hydrobromide", "PSEUDOEPHEDRINE HYDROCHLORIDE", "TRIPROLIDINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Competence of personnel (Article 23 of Directive No 2010/63/EU)" }, { "licence_number": "PA23490/003/001", "product_name": "Calpol 120 mg/5 ml Infant Oral Suspension", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1993-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/003/002", "product_name": "Calpol Six Plus 250 mg/5 ml Oral Suspension", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1995-01-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/003/003", "product_name": "Calpol Six Plus 250 mg/5 ml Sugar/Colour Free Oral Suspension", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1994-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/003/004", "product_name": "Calpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1993-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "ZZZ --Unknown--" }, { "licence_number": "PA23490/003/005", "product_name": "Calpol Six Plus Fastmelts 250 mg Paracetamol orodispersible tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/004/001", "product_name": "Benylin Dry Coughs Syrup Diphenhydramine hydrochloride 14 mg/5 ml Dextromethorphan hydrobromide 6.5 mg/5 ml Levomenthol 2 mg/5 ml", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1987-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R06AA", "R06AA52" ], "active_substances": [ "Diphenhydramine hydrochloride", "Dextromethorphan hydrobromide", "Levomenthol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "ZZZ --Unknown--" }, { "licence_number": "PA23490/005/001", "product_name": "Benylin Cough Medicine Syrup Diphenhydramine hydrochloride 14 mg/5 ml Levomenthol 1.1 mg/5 ml", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R06AA", "R06AA52" ], "active_substances": [ "Diphenhydramine hydrochloride", "Levomenthol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/006/001", "product_name": "BENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1988-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "PSEUDOEPHEDRINE HYDROCHLORIDE", "Paracetamol", "Diphenhydramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/007/001", "product_name": "Benylin Non-drowsy for Chesty Coughs Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1992-10-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA", "R05CA03" ], "active_substances": [ "Levomenthol", "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Competence of personnel (Article 23 of Directive No 2010/63/EU)" }, { "licence_number": "PA23490/008/001", "product_name": "Benylin Children’s Dry Coughs Syrup Diphenhydramine Hydrochloride 7 mg/5 ml Levomenthol 0.55 mg/5 ml", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1992-08-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R06AA", "R06AA52" ], "active_substances": [ "Levomenthol", "Diphenhydramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/009/001", "product_name": "Oraldene 0.1% w/v Gargle/Mouthwash", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1990-03-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gargle/mouthwash", "atc_codes": [ "A01AB", "A01AB12" ], "active_substances": [ "Hexetidine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/009/002", "product_name": "Oraldene Icemint 0.1% w/v Gargle/Mouthwash Hexetidine", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2002-04-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Gargle/mouthwash", "atc_codes": [ "A01AB", "A01AB12" ], "active_substances": [ "Hexetidine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/010/001", "product_name": "Benylin Non-Drowsy Dry Coughs, Syrup Dextromethorphan hydrobromide 7.5 mg/5 ml", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1994-11-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05DA", "R05DA09" ], "active_substances": [ "Dextromethorphan hydrobromide" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/011/001", "product_name": "Benylin Children’s Chesty Cough 50 mg/5 ml Syrup", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1998-07-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA", "R05CA03" ], "active_substances": [ "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "ZZZ Article 8.3(i)" }, { "licence_number": "PA23490/012/001", "product_name": "Sudafed 0.1% w/v Nasal spray solution", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2003-06-30", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AA", "R01AA07" ], "active_substances": [ "Xylometazoline hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/013/001", "product_name": "Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1998-06-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "PSEUDOEPHEDRINE HYDROCHLORIDE", "Diphenhydramine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/014/001", "product_name": "Migraleve Pink Film-coated Tablets Paracetamol 500mg Codeine Phosphate 8mg Buclizine Hydrochloride 6.25mg", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "BUCLIZINE HYDROCHLORIDE", "Codeine phosphate bp" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/014/002", "product_name": "Migraleve Yellow Film-coated Tablets Paracetamol 500mg Codeine phosphate 8mg", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/014/003", "product_name": "Migraleve Film-coated Tablets", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "BUCLIZINE HYDROCHLORIDE", "Paracetamol", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/015/001", "product_name": "Benylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 ml", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1997-04-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R01BA", "R01BA52" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE", "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/016/001", "product_name": "Colpermin Gastro-resistant Capsules Peppermint oil 0.2ml", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2006-03-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A03AX" ], "active_substances": [ "Peppermint oil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/017/001", "product_name": "Microlax Rectal Solution Sodium Citrate 450 mg/5 ml Sodium Lauryl Sulphoacetate 45 mg/5 ml", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1998-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Rectal solution", "atc_codes": [ "A06AG", "A06AG11" ], "active_substances": [ "Sodium citrate", "Sodium lauryl sulfoacetate" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/018/001", "product_name": "Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous foam", "atc_codes": [ "D11AX", "D11AX01" ], "active_substances": [ "Minoxidil" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/018/002", "product_name": "Regaine for Women Extra Strength Scalp Foam 5% w/w Cutaneous Foam", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2016-01-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous foam", "atc_codes": [ "D11AX", "D11AX01" ], "active_substances": [ "Minoxidil" ], "routes": [ "Topical" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/001", "product_name": "Nicorette Freshmint 2mg Medicated Chewing Gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2004-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/002", "product_name": "Nicorette Freshmint 4 mg Medicated Chewing Gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2004-12-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/003", "product_name": "Nicorette Freshfruit 2mg Medicated Chewing Gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/004", "product_name": "Nicorette Freshfruit 4mg Medicated Chewing Gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2006-05-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/005", "product_name": "Nicorette Invisi 10mg/16 hours Transdermal Patch", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2008-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Complete application (stand-alone) - Annex of Council Regulation (EEC) No 2309/93" }, { "licence_number": "PA23490/019/006", "product_name": "Nicorette Invisi 15mg/16 hours Transdermal Patch", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2008-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/007", "product_name": "Nicorette Invisi Extra Strength 25mg/16 hours Transdermal Patch", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2008-09-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/008", "product_name": "Nicorette Icy White 2mg Medicated Chewing Gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "ZZZ --Unknown--" }, { "licence_number": "PA23490/019/009", "product_name": "Nicorette Icy White 4mg Medicated Chewing Gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "ZZZ --Unknown--" }, { "licence_number": "PA23490/019/010", "product_name": "Nicorette 15mg Inhaler", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2011-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Inhalation vapour, impregnated plug", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/011", "product_name": "Nicorette Cools 2mg Lozenge", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2011-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/012", "product_name": "Nicorette Cools 4mg Lozenge", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2011-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/013", "product_name": "Nicorette Quickmist 1 mg/spray oromucosal spray, solution", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/014", "product_name": "Nicorette 2mg Medicated Chewing-gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2007-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/015", "product_name": "Nicorette 4mg Medicated Chewing-gum", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1997-10-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/019/016", "product_name": "Nicorette QuickMist Cool Berry 1 mg/spray, oromucosal spray, solution", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2017-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/017", "product_name": "Nicorette Fruit 2 mg Lozenges", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/019/018", "product_name": "Nicorette Fruit 4 mg Lozenges", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2017-12-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/020/001", "product_name": "Non-drowsy Sinutab Tablets Paracetamol 500mg Pseudoephedrine hydrochloride 30mg", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1998-02-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE", "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/021/001", "product_name": "Non-Drowsy Sudaplus Tablets Paracetamol 500mg Pseudoephedrine hydrochloride 30mg", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2011-06-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N02BE", "N02BE51" ], "active_substances": [ "Paracetamol", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/022/001", "product_name": "Motilium Fastmelts 10mg Orodispersible Tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2008-01-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/022/002", "product_name": "Motilium 10mg Film-Coated Tablets", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2007-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/023/001", "product_name": "Arret 2mg Hard Capsules", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1989-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/024/001", "product_name": "Stugeron 15 mg Tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1993-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA02" ], "active_substances": [ "Cinnarizine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/025/001", "product_name": "Imodium Instants 2 mg Orodispersible Tablets", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2003-10-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/025/002", "product_name": "Imodium 2 mg Capsules", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1977-04-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/025/003", "product_name": "Imodium LiquiRelief 2mg Soft Capsules", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2011-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/026/001", "product_name": "Vermox 100 mg/5 ml Oral Suspension", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2009-07-17", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "P02CA", "P02CA01" ], "active_substances": [ "Mebendazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/026/002", "product_name": "Vermox 100 mg tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1988-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "P02CA", "P02CA01" ], "active_substances": [ "Mebendazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/027/001", "product_name": "Pepcid Duo Chewable Tablets Famotidine 10 mg Magnesium Hydroxide 165 mg Calcium Carbonate 800 mg", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2000-09-29", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A02BA", "A02BA53" ], "active_substances": [ "Famotidine", "Magnesium hydroxide", "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/028/001", "product_name": "Daktarin 2% w/w Cream", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1988-03-31", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC02" ], "active_substances": [ "Miconazole nitrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/028/002", "product_name": "Daktarin 2% w/w Cutaneous Powder", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1977-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous powder", "atc_codes": [ "D01AC", "D01AC02" ], "active_substances": [ "Miconazole nitrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/028/003", "product_name": "Daktarin 20 mg/g Oral Gel", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1979-07-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral gel", "atc_codes": [ "A01AB", "A01AB09" ], "active_substances": [ "Miconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/029/001", "product_name": "ACTIFED 30 mg/1.25 mg per 5 ml Syrup", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R01BA", "R01BA02" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE", "TRIPROLIDINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/029/002", "product_name": "Actifed 60mg/2.5mg Tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1978-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R01BA", "R01BA02" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE", "TRIPROLIDINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/030/001", "product_name": "Imodium Plus 2 mg/125 mg Tablets", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2007-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "A07DA", "A07DA53" ], "active_substances": [ "Loperamide hydrochloride", "Simeticone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/031/001", "product_name": "Benylin Mucus Cough Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2011-09-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA", "R05CA03" ], "active_substances": [ "Levomenthol", "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/032/001", "product_name": "Pepcid AC 10 mg Film-coated Tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1996-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A02BA", "A02BA03" ], "active_substances": [ "Famotidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/033/001", "product_name": "Non-Drowsy Sudapro Head Cold 200mg/30mg Film-coated Tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2016-01-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R05X" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/034/001", "product_name": "Non-Drowsy Sudafed Decongestant 30 mg/5 ml Syrup", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1994-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R01BA", "R01BA02" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/034/002", "product_name": "Non-Drowsy Sudafed Decongestant 60 mg Film-Coated Tablets", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1979-04-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R01BA", "R01BA02" ], "active_substances": [ "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/036/001", "product_name": "Paracetamol 120 mg/5 ml Infant Oral Suspension", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/036/002", "product_name": "Paracetamol 120 mg/5 ml Sugar-Free Infant Oral Suspension", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2010-11-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/037/001", "product_name": "Benylin Mucus Relief 250 mg/5 ml Syrup", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2001-07-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CB", "R05CB03" ], "active_substances": [ "Carbocisteine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/038/001", "product_name": "Regaine for Women Regular Strength 2% w/v Cutaneous Solution", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1987-01-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D11AX", "D11AX01" ], "active_substances": [ "Minoxidil" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/038/002", "product_name": "Regaine Extra Strength 5% w/v Cutaneous Solution", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1995-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D11AX", "D11AX01" ], "active_substances": [ "Minoxidil" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA23490/039/001", "product_name": "Motilium 1 mg/ml Oral Suspension", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "1990-12-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/039/002", "product_name": "Motilium Rx 10 mg Film-coated Tablets", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "1990-12-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A03FA", "A03FA03" ], "active_substances": [ "Domperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/040/001", "product_name": "Benylin Mucus Cough Menthol 100 mg/5 ml oral solution", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R05CA", "R05CA03" ], "active_substances": [ "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/041/001", "product_name": "Benylin Mucus Cough Honey & Lemon 100mg/5ml Syrup", "holder": "JNTL Consumer Health (Ireland) Limited", "authorised_date": "2024-03-22", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA03" ], "active_substances": [ "Guaifenesin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA23490/042/001", "product_name": "Sudafed Plus 1 mg/ml + 50 mg/ml nasal spray, solution", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AB06" ], "active_substances": [ "Xylometazoline hydrochloride", "Dexpanthenol" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23504/001/001", "product_name": "Illuccix 25 micrograms kit for radiopharmaceutical preparation", "holder": "Telix Innovations", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Kit for radiopharmaceutical preparation", "atc_codes": [ "V09IX14" ], "active_substances": [ "Gozetotide" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23514/001/001", "product_name": "Belnifrem 1.5 mg film-coated tablets", "holder": "Adamed Pharma S.A.", "authorised_date": "2023-04-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA" ], "active_substances": [ "Cytisinicline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23514/002/001", "product_name": "Cytisinicline Adamed Pharma 1.5 mg film-coated tablets", "holder": "Adamed Pharma S.A.", "authorised_date": "2023-04-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BA04" ], "active_substances": [ "Cytisinicline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA23517/001/001", "product_name": "Lescol XL 80 mg Prolonged-release tablets", "holder": "Ethyx Pharmaceuticals", "authorised_date": "2002-01-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C10AA", "C10AA04" ], "active_substances": [ "Fluvastatin sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA23520/001/001", "product_name": "AMIDAFLUID 1 mg/ml, eye drops, solution", "holder": "Horus Pharma", "authorised_date": "2025-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01AX15" ], "active_substances": [ "Propamidine isetionate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25197/001/001", "product_name": "Mentholatum Deep Heat Cream", "holder": "The Mentholatum Company (Ireland) Limited", "authorised_date": "1990-07-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "M02AC" ], "active_substances": [ "Methyl salicylate", "Racementhol", "Eucalyptus oil", "Turpentine oil" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Not Currently Available" }, { "licence_number": "PA25197/002/001", "product_name": "Mentholatum Deep Heat Spray, cutaneous spray solution", "holder": "The Mentholatum Company (Ireland) Limited", "authorised_date": "1993-10-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Cutaneous spray, solution", "atc_codes": [ "M02AC" ], "active_substances": [ "Ethyl salicylate", "Hydroxyethyl Salicylate", "Methyl salicylate", "Methyl nicotinate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25205/001/001", "product_name": "Provigil 100 mg tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "1998-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA07" ], "active_substances": [ "Modafinil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25205/001/002", "product_name": "Provigil 200 mg tablets", "holder": "Neuraxpharm Pharmaceuticals S.L.", "authorised_date": "1998-05-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA", "N06BA07" ], "active_substances": [ "Modafinil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25208/001/001", "product_name": "Cialis for men 10 mg film-coated tablets", "holder": "A. Nattermann & Cie. GmbH", "authorised_date": "2023-12-01", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BE08" ], "active_substances": [ "Tadalafil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25213/001/001", "product_name": "Clindamycin 300 mg Capsules", "holder": "EG (Eurogenerics)", "authorised_date": "2009-05-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "D10AF", "D10AF01", "G01AA", "G01AA10", "J01F" ], "active_substances": [ "Clindamycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25222/001/001", "product_name": "Qsiva 3.75 mg/23 mg hard modified-release capsules", "holder": "Vivus B.V.", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "A08AA" ], "active_substances": [ "Phentermine hydrochloride", "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25222/001/002", "product_name": "Qsiva 7.5 mg/46 mg hard modified-release capsules", "holder": "Vivus B.V.", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "A08AA" ], "active_substances": [ "Phentermine hydrochloride", "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25222/001/003", "product_name": "Qsiva 11.25 mg/69 mg hard modified-release capsules", "holder": "Vivus B.V.", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "A08AA" ], "active_substances": [ "Phentermine hydrochloride", "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25222/001/004", "product_name": "Qsiva 15 mg/92 mg hard modified-release capsules", "holder": "Vivus B.V.", "authorised_date": "2024-10-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "A08AA" ], "active_substances": [ "Phentermine hydrochloride", "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25233/001/001", "product_name": "Bortezomib Biotech Pharma 3.5 mg powder for solution for injection", "holder": "Target Healthcare Limited", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L01XX32" ], "active_substances": [ "Bortezomib" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/001/001", "product_name": "Eribulin Tillomed 0.44 mg/ml solution for injection", "holder": "Tillomed Malta Limited", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "L01XX41" ], "active_substances": [ "Eribulin Mesilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/002/001", "product_name": "Cidofovir Tillomed 75 mg/ml concentrate for solution for infusion", "holder": "Tillomed Malta Limited", "authorised_date": "2025-09-19", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "J05AB12" ], "active_substances": [ "Cidofovir dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/003/001", "product_name": "Rivaroxaban Tillomed 2.5 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/003/002", "product_name": "Rivaroxaban Tillomed 10 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/003/003", "product_name": "Rivaroxaban Tillomed 15 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/003/004", "product_name": "Rivaroxaban Tillomed 15 mg film-coated tablets Rivaroxaban Tillomed 20 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban", "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/003/005", "product_name": "Rivaroxaban Tillomed 20 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2024-08-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B01AF01" ], "active_substances": [ "Rivaroxaban" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/004/001", "product_name": "Mylatabi 25 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/004/002", "product_name": "Mylatabi 50 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25239/004/003", "product_name": "Mylatabi 75 mg film-coated tablets", "holder": "Tillomed Malta Limited", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "B02BX05" ], "active_substances": [ "Eltrombopag olamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25244/001/001", "product_name": "Espestesin Forte 40 mg/ml + 10 microgram/ml solution for injection", "holder": "Pierrel S.p.A.", "authorised_date": "2003-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB58" ], "active_substances": [ "Articaine hydrochloride", "Epinephrine" ], "routes": [ "Dental use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25244/001/002", "product_name": "Espestesin 40 mg/ml + 5 microgram/ml solution for injection", "holder": "Pierrel S.p.A.", "authorised_date": "2003-02-21", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "N01BB", "N01BB58" ], "active_substances": [ "Articaine hydrochloride", "Epinephrine" ], "routes": [ "Dental use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25250/001/001", "product_name": "Fusidic acid/Betamethasone Laboratoires Medgen 20 mg/g + 1 mg/g Cream", "holder": "Laboratoires Medgen", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC01" ], "active_substances": [ "Fusidic acid", "Betamethasone valerate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25251/001/001", "product_name": "Abiraterone AshCure 250 mg film-coated tablets", "holder": "AshCure Pharma B.V.", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25251/001/002", "product_name": "Abiraterone AshCure 500 mg film-coated tablets", "holder": "AshCure Pharma B.V.", "authorised_date": "2026-01-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BX03" ], "active_substances": [ "Abiraterone acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25267/001/001", "product_name": "Larofec 250 mg film-coated granules in sachet", "holder": "C4 health GmbH", "authorised_date": "2026-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated granules in sachet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25267/001/002", "product_name": "Larofec 500 mg film-coated granules in sachet", "holder": "C4 health GmbH", "authorised_date": "2026-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated granules in sachet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25267/001/003", "product_name": "Larofec 750 mg film-coated granules in sachet", "holder": "C4 health GmbH", "authorised_date": "2026-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated granules in sachet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25267/001/004", "product_name": "Larofec 1000 mg film-coated granules in sachet", "holder": "C4 health GmbH", "authorised_date": "2026-02-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated granules in sachet", "atc_codes": [ "N03AX14" ], "active_substances": [ "Levetiracetam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25273/001/001", "product_name": "Lamotrigine PTR Pharma 5 mg tablets", "holder": "PTR Pharma Consulting Lda", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25273/001/004", "product_name": "Lamotrigine PTR Pharma 100 mg tablets", "holder": "PTR Pharma Consulting Lda", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25279/001/001", "product_name": "Zibor 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringes", "holder": "Gineladius S.L.", "authorised_date": "2002-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB12" ], "active_substances": [ "Bemiparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed 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"product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB", "B01AB12" ], "active_substances": [ "Bemiparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/001/001", "product_name": "Dianeal PD4 Glucose 1.36 % w/v (13.6 mg/ml), Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "1993-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose anhydrous", "Glucose monohydrate", "Sodium chloride", "Sodium lactate", "Calcium chloride dihydrate ph. eur.", "Magnesium 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"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/001/003", "product_name": "Dianeal PD4 Glucose 3.86 % w/v (38.6 mg/ml), Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "1993-06-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose anhydrous", "Glucose monohydrate", "Sodium chloride", "Sodium lactate", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/002/001", "product_name": "Nutrineal Solution for Peritoneal Dialysis 4 with 1.1% Amino Acids", "holder": "Vantive Belgium SRL", "authorised_date": "1994-08-08", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "L-tyrosine", "L-tryptophan", "L-phenylalanine", "L-threonine", "L-serine", "L-proline", "Glycine", "L-alanine", "L-valine", "L-methionine", "L-isoleucine", "L-leucine", "L-lysine hydrochloride", "L-histidine", "L-arginine", "Calcium chloride", "Magnesium chloride", "Sodium (S) - lactate", "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA25288/003/001", "product_name": "EXTRANEAL Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "1997-07-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DA" ], "active_substances": [ "Icodextrin", "Sodium chloride", "Sodium (S) - lactate", "Calcium chloride", "Magnesium chloride" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA25288/004/001", "product_name": "Physioneal 40 Glucose 1.36% w/v/13.6 mg/ml Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "1999-11-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Sodium bicarbonate", "Sodium (s)-lactate solution" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/004/002", "product_name": "Physioneal 40 Glucose 1.36% w/v/13.6 mg/ml Clear-Flex, Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Sodium (s)-lactate solution", "Sodium bicarbonate" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/004/003", "product_name": "Physioneal 40 Glucose 2.27% w/v/22.7 mg/ml Clear-Flex, Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Sodium (s)-lactate solution", "Sodium bicarbonate" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/004/004", "product_name": "Physioneal 40 Glucose 3.86% w/v/38.6 mg/ml Clear-Flex, Solution for 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"Sodium (s)-lactate solution" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/004/007", "product_name": "Physioneal 35 Glucose 1.36% w/v/13.6 mg/ml Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Sodium bicarbonate", "Sodium (s)-lactate solution" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through 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"dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Calcium chloride dihydrate", "Magnesium chloride hexahydrate", "Sodium (s)-lactate solution", "Sodium bicarbonate" ], "routes": [ "Intraperitoneal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/004/011", "product_name": "Physioneal 35 Glucose 2.27% w/v/22.7 mg/ml Clear-Flex, Solution for peritoneal dialysis", "holder": "Vantive Belgium SRL", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for peritoneal dialysis", "atc_codes": [ "B05DB" ], "active_substances": [ "Glucose monohydrate", "Sodium chloride", "Calcium chloride dihydrate", "Magnesium 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"dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Glucose (as monohydrate)", "Magnesium chloride hexahydrate", "Calcium chloride dihydrate", "Lactic acid", "Sodium chloride", "Potassium chloride", "Sodium hydrogen carbonate", "Calcium", "Magnesium", "Sodium", "Lactate", "Hydrogen carbonate", "Chloride", "Potassium", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/006/002", "product_name": "Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration", "holder": "Vantive Belgium SRL", "authorised_date": "2007-10-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Glucose (as monohydrate)", "Magnesium chloride hexahydrate", "Calcium chloride dihydrate", "Lactic acid", "Sodium chloride", "Potassium chloride", "Sodium hydrogen carbonate", "Calcium", "Magnesium", "Sodium", "Chloride", "Lactate", "Hydrogen carbonate", "Potassium", "Glucose" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/006/003", "product_name": "Prismasol 4 mmol/l Potassium solution for haemodialysis/haemofiltration", "holder": "Vantive Belgium SRL", "authorised_date": "2007-10-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Glucose (as 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"Disodium phosphate dihydrate" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/008/001", "product_name": "Regiocit Solution for haemofiltration", "holder": "Vantive Belgium SRL", "authorised_date": "2014-11-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Solution for haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Sodium citrate", "Sodium chloride" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/009/001", "product_name": "Biphozyl Solution for haemodialysis/haemofiltration", "holder": "Vantive Belgium SRL", "authorised_date": "2014-11-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for haemodialysis/haemofiltration", "atc_codes": [ "B05ZB" ], "active_substances": [ "Magnesium chloride hexahydrate", "Sodium chloride", "Sodium hydrogen carbonate", "Potassium chloride", "Disodium phosphate dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25288/010/001", "product_name": "Icalziss 340 mmol/L solution for infusion", "holder": "Vantive Belgium SRL", "authorised_date": "2025-03-14", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for infusion", "atc_codes": [ "B05XA07" ], "active_substances": [ "Calcium chloride dihydrate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25290/001/001", "product_name": "Modafinil Forza 100 mg tablets", "holder": "Forza Advance Limited", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA07" ], "active_substances": [ "Modafinil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25299/001/001", "product_name": "Nimotop 30 mg film-coated tablets", "holder": "Laboratoire X.O", "authorised_date": "1994-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA06" ], "active_substances": [ "Nimodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25299/001/002", "product_name": "Nimotop 0.02% w/v Concentrate for Solution for Infusion", "holder": "Laboratoire X.O", "authorised_date": "1994-02-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for solution for infusion", "atc_codes": [ "C08CA", "C08CA06" ], "active_substances": [ "Nimodipine" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25306/001/001", "product_name": "Roaccutane 10 mg soft capsules", "holder": "Cheplapharm Registration GmbH", "authorised_date": "2006-11-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA", "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25306/001/002", "product_name": "Roaccutane 20 mg soft capsules", "holder": "Cheplapharm Registration GmbH", "authorised_date": "1983-04-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "D10BA", "D10BA01" ], "active_substances": [ "Isotretinoin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25312/001/001", "product_name": "Gyxiny 25 microgram tablets", "holder": "Afyx Therapeutics A/S", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02AD06" ], "active_substances": [ "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25340/001/001", "product_name": "Matrifen 12 micrograms/hour Transdermal patch", "holder": "Istituto Gentili S.r.l.", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25340/001/002", "product_name": "Matrifen 25 micrograms/hour Transdermal patch", "holder": "Istituto Gentili S.r.l.", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25340/001/003", "product_name": "Matrifen 50 micrograms/hour Transdermal patch", "holder": "Istituto Gentili S.r.l.", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25340/001/004", "product_name": "Matrifen 75 micrograms/hour Transdermal patch", "holder": "Istituto Gentili S.r.l.", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25340/001/005", "product_name": "Matrifen 100 micrograms/hour Transdermal patch", "holder": "Istituto Gentili S.r.l.", "authorised_date": "2006-10-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB", "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25340/002/001", "product_name": "Ozalin 2 mg/ml oral solution in single-dose container", "holder": "Istituto Gentili S.r.l.", "authorised_date": "2020-04-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution in single-dose container", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25342/003/001", "product_name": "Sigmopan 10 mg film-coated tablets", "holder": "Ria Generics Limited", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A03BB01" ], "active_substances": [ "Hyoscine butylbromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25354/001/001", "product_name": "Nilotinib Olpha 150 mg hard capsules", "holder": "Olpha AS", "authorised_date": "2026-09-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EA03" ], "active_substances": [ "Nilotinib hydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25354/001/002", "product_name": "Nilotinib Olpha 200 mg hard capsules", "holder": "Olpha AS", "authorised_date": "2026-09-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L01EA03" ], "active_substances": [ "Nilotinib hydrochloride monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25355/001/001", "product_name": "Methacholine chloride 100 mg Powder for nebuliser solution", "holder": "Methapharm Limited", "authorised_date": "2020-06-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for nebuliser solution", "atc_codes": [ "V04CX", "V04CX03" ], "active_substances": [ "Methacholine Chloride" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25361/001/001", "product_name": "Vocasept 8.75 mg Lozenges", "holder": "Mapaex Consumer Healthcare (Ireland) Private Limited", "authorised_date": "2026-07-31", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AX01" ], "active_substances": [ "Flurbiprofen" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25363/001/001", "product_name": "Cefotaxime Reiwa Healthcare 1g powder for solution for injection/infusion", "holder": "Reiwa Healthcare S.L.", "authorised_date": "2018-04-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01DD", "J01DD01" ], "active_substances": [ "Cefotaxime" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/005/001", "product_name": "Anastrozole Amarox 1 mg film-coated tablets", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/009/001", "product_name": "Prucalopride Amarox 1 mg film-coated tablets", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AX05" ], "active_substances": [ "Prucalopride Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/009/002", "product_name": "Prucalopride Amarox 2 mg film-coated tablets", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-09-24", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A06AX05" ], "active_substances": [ "Prucalopride Succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/014/001", "product_name": "Telmisartan 20 mg tablets", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-07-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/014/002", "product_name": "Telmisartan 40 mg tablets", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-07-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/014/003", "product_name": "Telmisartan 80 mg tablets", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-07-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA07" ], "active_substances": [ "Telmisartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25364/016/001", "product_name": "Voriconazole Amarox 200 mg powder for solution for infusion", "holder": "Amarox Pharma B.V.", "authorised_date": "2026-04-09", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for infusion", "atc_codes": [ "J02AC03" ], "active_substances": [ "Voriconazole" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25373/001/001", "product_name": "Padolieve 500mg film coated tablets", "holder": "A.forall Development", "authorised_date": "2014-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25373/001/002", "product_name": "Padolieve Max 1000mg film coated tablets", "holder": "A.forall Development", "authorised_date": "2014-10-03", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02BE", "N02BE01" ], "active_substances": [ "Paracetamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25377/001/001", "product_name": "Sativex oromucosal spray", "holder": "CNX Therapeutics Ireland Limited", "authorised_date": "2014-07-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "N02B", "N02BG10" ], "active_substances": [ "Delta-9-tetrahydrocannabinol botanical drug substance (thc bds)", "CANNABIDIOL" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25384/001/001", "product_name": "Minreksav 1.5 mg/pump actuation oral solution", "holder": "Profit Sylwia Gil", "authorised_date": "2026-02-27", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N07BA04" ], "active_substances": [ "Cytisinicline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25390/002/001", "product_name": "Codeine phosphate hemihydrate 10 mg tablets", "holder": "Extractum Pharma zrt", "authorised_date": "2025-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R05DA04" ], "active_substances": [ "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25390/002/002", "product_name": "Codeine phosphate hemihydrate 15 mg tablets", "holder": "Extractum Pharma zrt", "authorised_date": "2025-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R05DA04" ], "active_substances": [ "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25390/002/003", "product_name": "Codeine phosphate hemihydrate 20 mg tablets", "holder": "Extractum Pharma zrt", "authorised_date": "2025-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R05DA04" ], "active_substances": [ "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25390/002/004", "product_name": "Codeine phosphate hemihydrate 30 mg tablets", "holder": "Extractum Pharma zrt", "authorised_date": "2025-06-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R05DA04" ], "active_substances": [ "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25393/001/001", "product_name": "Galliad 0.74 to 1.85 GBq Radionuclide generator", "holder": "IRE Elit", "authorised_date": "2026-01-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Radionuclide generator", "atc_codes": [ "V09X" ], "active_substances": [ "GERMANIUM (68GE) CHLORIDE" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25405/001/001", "product_name": "Quinoderm 10% w/w + 0.5% w/w Cream", "holder": "UMIP Limited", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AE", "D10AE01" ], "active_substances": [ "Benzoyl peroxide hydrous", "Potassium Hydroxyquinoline Sulphate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25405/001/002", "product_name": "Quinoderm 5% w/w + 0.5% w/w Cream", "holder": "UMIP Limited", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AE", "D10AE01" ], "active_substances": [ "Benzoyl peroxide hydrous", "Potassium Hydroxyquinoline Sulphate" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25408/001/001", "product_name": "SoluPrep 2% w/v/70% v/v cutaneous solution", "holder": "Solventum Germany GmbH", "authorised_date": "2019-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AC", "D08AC52" ], "active_substances": [ "Chlorhexidine gluconate", "Isopropyl alcohol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25408/001/002", "product_name": "SoluPrep with tint 2% w/v/70% v/v cutaneous solution", "holder": "Solventum Germany GmbH", "authorised_date": "2019-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D08AC", "D08AC52" ], "active_substances": [ "Chlorhexidine gluconate", "Isopropyl alcohol" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25414/001/001", "product_name": "Desferal 500mg Vials Powder for Solution for Injection or Powder for Concentrate for Solution for Infusion", "holder": "Mitem Pharma", "authorised_date": "1980-02-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "V03AC", "V03AC01" ], "active_substances": [ "Deferoxamine mesilate" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25429/001/001", "product_name": "Naltrexone 50 mg film-coated tablets", "holder": "Walter Ritter GmbH & Co. KG", "authorised_date": "2005-03-11", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BB", "N07BB04" ], "active_substances": [ "Naltrexone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25429/002/001", "product_name": "Ethylex 50 mg film-coated tablets", "holder": "Walter Ritter GmbH & Co. KG", "authorised_date": "2004-04-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N07BB", "N07BB04" ], "active_substances": [ "Naltrexone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25429/003/001", "product_name": "Tetrabenazine 25 mg Tablets", "holder": "Walter Ritter GmbH & Co. KG", "authorised_date": "2010-09-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07XX", "N07XX06" ], "active_substances": [ "Tetrabenazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25435/001/001", "product_name": "Tyedra 1500 micrograms tablet", "holder": "Maxmind Pharmaceutical GmbH", "authorised_date": "2013-11-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AD", "G03AD01" ], "active_substances": [ "Levonorgestrel micronized" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25441/001/001", "product_name": "Amlodipine Masuu 5 mg tablets", "holder": "Masuu Pharma Europe Limited", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25441/001/002", "product_name": "Amlodipine Masuu 10 mg tablets", "holder": "Masuu Pharma Europe Limited", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA", "C08CA01" ], "active_substances": [ "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/001/001", "product_name": "Nicotinell TTS 10, 7mg/24 hours Transdermal Patch", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "1995-11-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/001/002", "product_name": "Nicotinell TTS 20, 14mg/24 hours Transdermal Patch", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "1995-11-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/001/003", "product_name": "Nicotinell TTS 30, 21mg/24 hours Transdermal Patch", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "1995-11-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/001/004", "product_name": "Nicotinell Mint 1 mg compressed lozenge", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "1999-08-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine bitartrate dihydrate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/001/005", "product_name": "Nicotinell Mint 2 mg compressed lozenge", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2003-11-04", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine bitartrate dihydrate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/002/001", "product_name": "Nicotinell Fruit 2 mg, medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/002/002", "product_name": "Nicotinell Fruit 4 mg, medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/003/001", "product_name": "Nicotinell Cool Mint 2 mg, medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/003/002", "product_name": "Nicotinell Cool Mint 4 mg, medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2001-04-06", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/004/001", "product_name": "Nicotinell Fruitfusion 2 mg medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2012-02-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/004/002", "product_name": "Nicotinell Fruitfusion 2 mg medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2012-02-10", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/005/001", "product_name": "Nicotinell Tropical Fruit 2 mg medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2012-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/005/002", "product_name": "Nicotinell Tropical Fruit 4 mg medicated chewing-gum", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2012-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Medicated chewing-gum", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25456/006/001", "product_name": "Nicotinell Rapid Relief 1 mg/spray oromucosal spray, solution", "holder": "Dr. Reddy's Netherlands B.V.", "authorised_date": "2023-08-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25477/001/001", "product_name": "Fusidic acid/Betamethasone Bailleul 20 mg/g + 1 mg/g Cream", "holder": "Laboratoires Bailleul S.A.", "authorised_date": "2025-09-05", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC01" ], "active_substances": [ "Fusidic acid", "Betamethasone valerate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/001/001", "product_name": "Amylmetacresol/2,4-Dichlorobenzyl alcohol Cooper 0.6 mg/1.2 mg honey & lemon lozenges", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2021-02-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "2,4 DICHLOROBENZYL ALCOHOL", "Amylmetacresol" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/001/002", "product_name": "Amylmetacresol/2,4-Dichlorobenzyl alcohol Cooper 0.6 mg/1.2 mg mint lozenges", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2021-02-26", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Lozenge", "atc_codes": [ "R02AA", "R02AA03" ], "active_substances": [ "Amylmetacresol", "2,4 DICHLOROBENZYL ALCOHOL" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/002/001", "product_name": "Viartril 1500 mg Powder for Oral Solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2005-07-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Glucosamine sulphate sodium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/003/001", "product_name": "Lactecon 3.335g/5ml oral solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2000-12-08", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "A06AD", "A06AD11" ], "active_substances": [ "Lactulose" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/004/001", "product_name": "Dona 500mg Capsules", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2006-07-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Glucosamine sulfate sodium chloride", "GLUCOSAMINE SULPHATE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Known active substance (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/004/002", "product_name": "Dona 1500 mg Powder for oral solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "1998-04-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "M01AX", "M01AX05" ], "active_substances": [ "Sodium chloride", "Glucosamine sulfate sodium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/005/001", "product_name": "Difflam Oral Rinse 0.15% w/v, gargle", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2008-04-18", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gargle", "atc_codes": [ "A01AD", "A01AD02" ], "active_substances": [ "BENZYDAMINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA25506/005/002", "product_name": "Difflam Spray, 0.15% w/v, Oromucosal Spray", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2008-06-20", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray", "atc_codes": [ "A01AD", "A01AD02" ], "active_substances": [ "BENZYDAMINE HYDROCHLORIDE" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA25506/006/001", "product_name": "Rhinolast 140 micrograms per Spray, Nasal Spray", "holder": "Cooper Consumer Health B.V.", "authorised_date": "1994-12-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AC", "R01AC03" ], "active_substances": [ "Azelastine hydrochloride" ], "routes": [ "Intranasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/006/002", "product_name": "Rhinolast Hayfever 140 micrograms per spray, nasal spray solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2001-02-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AC", "R01AC03" ], "active_substances": [ "Azelastine hydrochloride" ], "routes": [ "Intranasal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/006/003", "product_name": "Rhinolast S nasal spray, solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2013-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AC", "R01AC03" ], "active_substances": [ "Azelastine hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/007/001", "product_name": "Astepro 1.5 mg/ml nasal spray, solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2013-09-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "R01AC", "R01AC03" ], "active_substances": [ "Azelastine hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/008/001", "product_name": "Azelastine Eye Drops 0.5 mg/ml Eye Drops, solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "1998-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX07" ], "active_substances": [ "Azelastine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PA25506/009/001", "product_name": "Optilast, 0.5 mg/ml Eye Drops, solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "1998-08-28", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01GX", "S01GX07" ], "active_substances": [ "Azelastine hydrochloride" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/010/001", "product_name": "WAXSOL 0.5% w/v Ear Drops Solution", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2011-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Ear drops, solution", "atc_codes": [ "S02DC" ], "active_substances": [ "Docusate sodium" ], "routes": [ "Not Currently Available" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/011/001", "product_name": "Kalcipos-D forte 500 mg/800 IU film-coated tablets", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium", "Cholecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25506/011/002", "product_name": "Kalcipos-D forte 500 mg/800 IU chewable tablets", "holder": "Cooper Consumer Health B.V.", "authorised_date": "2010-05-21", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium", "Vitamin d3" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Well-established use application (Article 10a of Directive No 2001/83/EC)" }, { "licence_number": "PA25562/001/001", "product_name": "Methotrexate 2.5 mg Tablets", "holder": "Abcur AB", "authorised_date": "1983-05-23", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L04AX", "L04AX03" ], "active_substances": [ "Methotrexate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25573/001/001", "product_name": "Nazalam 2.5 mg nasal spray, solution in single-dose container", "holder": "Kelso Pharma Ireland Limited", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution in single-dose container", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25573/001/002", "product_name": "Nazalam 3.75 mg nasal spray, solution in single-dose container", "holder": "Kelso Pharma Ireland Limited", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution in single-dose container", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25573/001/003", "product_name": "Nazalam 5 mg nasal spray, solution in single-dose container", "holder": "Kelso Pharma Ireland Limited", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Nasal spray, solution in single-dose container", "atc_codes": [ "N05CD08" ], "active_substances": [ "Midazolam hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Hybrid application (Article 10(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25595/001/001", "product_name": "Paracetamol/Ibuprofen 500 mg/150 mg powder for oral solution in sachet", "holder": "Aft Pharmaceuticals (Eur) Limited", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen lysine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25595/001/002", "product_name": "Paracetamol/Ibuprofen 1000 mg/300mg powder for oral solution in sachet", "holder": "Aft Pharmaceuticals (Eur) Limited", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen lysine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25595/002/001", "product_name": "Paracetamol/Ibuprofen Vale 500 mg/150 mg powder for oral solution in sachet", "holder": "Aft Pharmaceuticals (Eur) Limited", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen lysine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25595/002/002", "product_name": "Paracetamol/Ibuprofen Vale 1000 mg/300mg powder for oral solution in sachet", "holder": "Aft Pharmaceuticals (Eur) Limited", "authorised_date": "2025-08-29", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "N02BE51" ], "active_substances": [ "Paracetamol", "Ibuprofen lysine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25636/001/001", "product_name": "Flucloxacillin 500 mg powder for solution for injection or infusion", "holder": "Antibiotice S.A.", "authorised_date": "2019-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "Flucloxacillin" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25636/001/002", "product_name": "Flucloxacillin 1000 mg powder for solution for injection or infusion", "holder": "Antibiotice S.A.", "authorised_date": "2019-08-13", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Powder for solution for injection/infusion", "atc_codes": [ "J01CF", "J01CF05" ], "active_substances": [ "FLUCLOXACILLIN SODIUM" ], "routes": [ "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25641/001/001", "product_name": "Alvesco 80 micrograms pressurised inhalation, solution", "holder": "Azurity Pharmaceuticals Ireland Limited", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA08" ], "active_substances": [ "Ciclesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25641/001/002", "product_name": "Alvesco 160 micrograms pressurised inhalation, solution", "holder": "Azurity Pharmaceuticals Ireland Limited", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA08" ], "active_substances": [ "Ciclesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PA25649/002/001", "product_name": "Apremilast nio 10 mg + 20mg + 30 mg film-coated tablets", "holder": "nio Health GmbH", "authorised_date": "2025-11-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast", "Apremilast", "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25649/002/002", "product_name": "Apremilast nio 30 mg film-coated tablets", "holder": "nio Health GmbH", "authorised_date": "2025-11-07", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AA32" ], "active_substances": [ "Apremilast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Generic application (Article 10(1) of Directive No 2001/83/EC)" }, { "licence_number": "PA25676/001/001", "product_name": "Sugammadex 100 mg/ml solution for injection", "holder": "Tamarang S.A.", "authorised_date": "2022-12-16", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "V03AB35" ], "active_substances": [ "Sugammadex 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"2018-04-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Transdermal gel", "atc_codes": [ "G03BA", "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)" }, { "licence_number": "PPA0465/001/002", "product_name": "Imodium Instants 2 mg Orodispersible Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/038/008", "product_name": "Zovirax 200 mg/5 mL oral suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-05-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/048/001", "product_name": "Canesten 10 mg/g Cream", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2000-04-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AC", "D01AC01" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/048/002", "product_name": "Canesten 500 mg pessary", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2006-03-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pessary", "atc_codes": [ "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/048/004", "product_name": "Canesten Thrush Cream", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2010-05-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Cutaneous use", "Topical", "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/050/001", "product_name": "Dianette 2 mg/35 microgram coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "1998-10-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03HB", "G03HB01" ], "active_substances": [ "Cyproterone acetate", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/062/001", "product_name": "Lustral 50 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-09-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/062/002", "product_name": "Lustral 100 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-09-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB06" ], "active_substances": [ "Sertraline hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/065/001", "product_name": "Istin 5 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2000-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/065/002", "product_name": "Istin 10 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2000-11-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C08CA01" ], "active_substances": [ "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/066/005", "product_name": "Zestril 5 mg Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-10-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA03" ], "active_substances": [ "Lisinopril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/073/001", "product_name": "Flixotide Evohaler 125 micrograms per metered dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/073/002", "product_name": "Flixotide Evohaler 250 micrograms per metered dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-09-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/073/005", "product_name": "Flixotide Evohaler 50 micrograms per metered dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2019-05-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA", "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/075/001", "product_name": "Lipitor 10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/075/002", "product_name": "Lipitor 20 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/075/003", "product_name": "Lipitor 40 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2001-07-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA05" ], "active_substances": [ "Atorvastatin" ], "routes": [ "Oral 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"authorised_date": "2001-09-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/083/001", "product_name": "Nexium 20 mg gastro-resistant tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2002-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX", "N06AX16" ], "active_substances": [ "Venlafaxine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/085/005", "product_name": "Efexor XL 150 mg prolonged-release capsules, hard", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-08-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06AX16" ], "active_substances": [ "Venlafaxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/091/001", "product_name": "Seretide 100 Diskus 50 microgram/100 microgram/dose inhalation powder, pre-dispensed", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/091/002", "product_name": "Seretide 250 Diskus, 50 microgram/250 microgram/dose inhalation powder, pre-dispensed", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/091/003", "product_name": "Seretide 500 Diskus, 50 microgram/500 microgram/dose inhalation powder, pre-dispensed", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/091/005", "product_name": "Seretide 125 Evohaler 25 microgram/125 microgram/dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "SALMETEROL XINAFOATE" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/091/006", "product_name": "Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "SALMETEROL XINAFOATE", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/092/005", "product_name": "Lamictal 5 mg chewable/dispersible tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-07-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable/dispersible 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"PPA0465/092/010", "product_name": "Lamictal 100 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/092/011", "product_name": "Lamictal 25 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-05-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which 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"registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/096/001", "product_name": "Lamisil 250 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "D01BA02" ], "active_substances": [ "Terbinafine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/098/001", "product_name": "Proscar 5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-01-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04CB", "G04CB01" ], "active_substances": [ "Finasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/099/001", "product_name": "Zomig 2.5 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-05-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC03" ], "active_substances": [ "Zolmitriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/099/002", "product_name": "Zomig Rapimelt 2.5 mg Orodispersible Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-11-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02CC", "N02CC03" ], "active_substances": [ "Zolmitriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/106/001", "product_name": "Cozaar 50 mg film-coated tablets", "holder": "PCO Manufacturing 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"Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/109/001", "product_name": "Cozaar Comp 50 mg/12.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-01-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Hydrochlorothiazide", "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/109/002", "product_name": "Cozaar Comp 100 mg/25 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2008-02-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA", "C09CA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/109/004", "product_name": "Cozaar Comp 100 mg/12.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA01" ], "active_substances": [ "Hydrochlorothiazide", "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply 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"AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/113/001", "product_name": "Zofran 4 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-10-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/113/002", "product_name": "Zofran 8 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2003-10-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/114/001", "product_name": "Arthrotec 50 modified-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AB", "M01AB55" ], "active_substances": [ "Misoprostol", "Diclofenac sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/114/002", "product_name": "Arthrotec 75 modified-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AB", "M01AB55" ], "active_substances": [ "Diclofenac sodium", "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/116/001", "product_name": "Atacand 8 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/116/002", "product_name": "Atacand 16 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/117/001", "product_name": "Atacand Plus 16 mg/12.5 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-01-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/118/002", "product_name": "Celebrex 200 mg hard capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-03-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "M01AH", "M01AH01" ], "active_substances": [ "Celecoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/125/001", "product_name": "Creon 10000 Gastro-resistant Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/125/002", "product_name": "Creon 25000 Gastro-resistant Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-06-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/129/001", "product_name": "Lexapro 10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-03-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/129/002", "product_name": "Lexapro 20 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-03-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/129/004", "product_name": "Lexapro 15 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-07-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB", "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/129/005", "product_name": "Lexapro 5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/134/002", "product_name": "One-Alpha 1 microgram soft capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-09-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC03" ], "active_substances": [ "Alfacalcidol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/144/001", "product_name": "Casodex 50 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2004-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/146/001", "product_name": "NASONEX 50 micrograms/actuation Nasal Spray, Suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-08-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD09" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/151/001", "product_name": "Lamisil 1% w/w cream", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-12-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01AE", "D01AE15" ], "active_substances": [ "Terbinafine hydrochloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/155/001", "product_name": "Arret 2 mg Hard Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-11-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/156/001", "product_name": "Calcichew 500 mg chewable tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-12-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AA", "A12AA04" ], "active_substances": [ "Calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/156/003", "product_name": "Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-10-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AA04" ], "active_substances": [ "Calcium carbonate", "Colecalciferol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/156/004", "product_name": "Calcichew-D3 Forte Double Strength 1000 mg/800 IU Chewable Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-10-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AX" ], "active_substances": [ "Calcium carbonate", "Cholecalciferol concentrate (powder form)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/160/001", "product_name": "Salazopyrin EN Tabs 500 mg Gastro-resistant tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-09-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC", "A07EC01" ], "active_substances": [ "Sulfasalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/165/001", "product_name": "Risedronate Sodium Accord Once a Week 35 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-11-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M05BA07" ], "active_substances": [ "Risedronate sodium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/166/002", "product_name": "Reminyl XL 8 mg prolonged-release capsules, hard", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/166/003", "product_name": "Reminyl XL 24 mg prolonged-release capsules, hard", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/166/004", "product_name": "Reminyl XL 16 mg prolonged-release capsules, hard", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine hydrobromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/171/001", "product_name": "Omnexel, 400 micrograms prolonged release tablets, film-coated", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2005-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/176/001", "product_name": "Arcoxia 60 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2006-04-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/176/004", "product_name": "Arcoxia 30 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2010-10-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/183/001", "product_name": "Ursofalk 250 mg hard capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2006-11-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA02", "A05AA" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/183/002", "product_name": "Ursofalk 500 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-03-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/187/007", "product_name": "Nicorette Invisi 10 mg/16 hours transdermal patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/187/008", "product_name": "Nicorette Invisi 15 mg/16 hours transdermal patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/187/009", "product_name": "Nicorette Invisi Extra Strength 25 mg/16 hours transdermal patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-08-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA", "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/196/001", "product_name": "Topamax 25mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2007-03-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/196/002", "product_name": "Topamax 50mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2007-03-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/196/003", "product_name": "Topamax 100 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2007-03-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/196/004", "product_name": "Topamax 200 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2007-03-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/205/001", "product_name": "Dalacin C 150 mg Hard Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2007-10-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "D10AF", "D10AF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/211/001", "product_name": "Avodart 0.5 mg soft capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2008-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G04CB", "G04CB02" ], "active_substances": [ "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/212/001", "product_name": "Famvir 250 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2008-09-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/212/002", "product_name": "Famvir 500 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/218/001", "product_name": "Arimidex 1 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-05-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/226/001", "product_name": "Co-Diovan 80 mg/12.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA03" ], "active_substances": [ "Hydrochlorothiazide", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/226/002", "product_name": "Co-Diovan 160 mg/12.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA03" ], "active_substances": [ "Hydrochlorothiazide", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/226/003", "product_name": "Co-Diovan 160 mg/25 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA03" ], "active_substances": [ "Hydrochlorothiazide", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/226/004", "product_name": "Co-Diovan 320 mg/25 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-11-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/226/005", "product_name": "Co-Diovan 320 mg/12.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/227/001", "product_name": "Ezetrol 10 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-07-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AX", "C10AX09" ], "active_substances": [ "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/230/001", "product_name": "Avelox 400 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01MA", "J01MA14" ], "active_substances": [ "Moxifloxacin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/231/002", "product_name": "Fucibet Lipid 20 mg/g + 1 mg/g cream", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-07-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC01" ], "active_substances": [ "Betamethasone", "Fusidic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/234/001", "product_name": "Loceryl 5% w/v Medicated Nail Lacquer", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-08-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicated nail lacquer", "atc_codes": [ "D01AE", "D01AE16" ], "active_substances": [ "Amorolfine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/236/001", "product_name": "Aromasin 25 mg coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2009-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "L02BG", "L02BG06" ], "active_substances": [ "Exemestane" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/244/001", "product_name": "Epanutin 100 mg Hard Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-04-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "N03AB", "N03AB02" ], "active_substances": [ "PHENYTOIN SODIUM" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/247/001", "product_name": "Trosyl 283 mg/ml Nail Solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2010-08-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D01AC", "D01AC07" ], "active_substances": [ "Tioconazole" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/250/001", "product_name": "Implanon NXT, 68 mg implant for subdermal use", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-05-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "G03AC08" ], "active_substances": [ "Etonogestrel" ], "routes": [ "Implantation" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Informed consent application (Article 13c of Directive No 2001/82/EC)" }, { "licence_number": "PPA0465/256/001", "product_name": "Tetralysal 300 mg hard capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2010-10-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA", "J01AA04" ], "active_substances": [ "Lymecycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/259/001", "product_name": "Celluvisc 1.0% w/v eye drops, solution, unit dose", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-04-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01XA20" ], "active_substances": [ "Carmellose sodium" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/260/001", "product_name": "Desmotabs Melt 120 micrograms oral lyophilisate", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-07-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA", "H01BA02" ], "active_substances": [ "Desmopressin" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/261/001", "product_name": "Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/261/002", "product_name": "Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2020-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin pamoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/262/001", "product_name": "Vesitirim 5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/262/002", "product_name": "Vesitirim 10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/279/001", "product_name": "Requip-Modutab 8mg Prolonged-Release Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-08-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/279/002", "product_name": "Requip-Modutab 2 mg Prolonged-Release Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/279/003", "product_name": "Requip-Modutab 4 mg Prolonged-Release Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC", "N04BC04" ], "active_substances": [ "Ropinirole hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/281/001", "product_name": "Regurin 20 mg coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2011-09-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G04BD09" ], "active_substances": [ "Trospium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/286/001", "product_name": "Spiriva Respimat 2.5 microgram, inhalation solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation solution", "atc_codes": [ "R03BB", "R03BB04" ], "active_substances": [ "Tiotropium" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/287/001", "product_name": "ACULAR 0.5% w/v Eye drops, solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-07-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01BC", "S01BC05" ], "active_substances": [ "Ketorolac trometamol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/288/001", "product_name": "NORLEVO 1.5 mg tablet", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-06-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G03AD", "G03AD01" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/289/001", "product_name": "Mezavant XL 1200 mg gastro-resistant, prolonged release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-06-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/292/001", "product_name": "Mirena 52 mg Intrauterine Delivery System", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-08-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/296/001", "product_name": "COSOPT 20 mg/ml + 5 mg/ml eye drops, solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-10-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Dorzolamide", "Timolol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/299/001", "product_name": "Versatis 700 mg medicated plaster", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-11-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "N01BB", "N01BB02" ], "active_substances": [ "Lidocaine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/301/001", "product_name": "Crinone 8% w/w progesterone vaginal gel", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-02-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Vaginal gel", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/308/001", "product_name": "Trileptal 300 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/308/002", "product_name": "Trileptal 600 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/308/003", "product_name": "Trileptal 60 mg/ml oral suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2016-07-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/314/001", "product_name": "Durogesic DTrans 25 micrograms/hour Transdermal Patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/314/002", "product_name": "Durogesic DTrans 50 micrograms/hour Transdermal Patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/314/003", "product_name": "Durogesic DTrans 75 micrograms/hour Transdermal Patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/314/004", "product_name": "Durogesic DTrans 100 micrograms/hour Transdermal Patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/314/005", "product_name": "Durogesic DTrans 12 micrograms/hour Transdermal Patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/320/001", "product_name": "Lopid 600 mg film-coated tablet", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AB", "C10AB04" ], "active_substances": [ "Gemfibrozil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/321/001", "product_name": "FROVEX 2.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC", "N02CC07" ], "active_substances": [ "Frovatriptan succinate monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/323/001", "product_name": "Megace 40 mg/ml oral suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-11-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/323/002", "product_name": "Megace 160 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02AB", "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/324/001", "product_name": "Saflutan 15 micrograms/ml, eye drops, solution in single-dose container", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2013-11-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01EE", "S01EE05" ], "active_substances": [ "Tafluprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/334/001", "product_name": "Combodart 0.5 mg/0.4 mg hard capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA", "G04CA52" ], "active_substances": [ "Dutasteride", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/335/001", "product_name": "Omacor 1000 mg Soft Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "C10AX", "C10AX06" ], "active_substances": [ "Omega-3-acid ethyl esters 90" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/337/001", "product_name": "Nurofen for Children Orange 100 mg/5 ml oral suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-08-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/337/002", "product_name": "Nurofen Cold & Flu film-coated tablets Ibuprofen 200mg Pseudoephedrine hydrochloride 30mg", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-11-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AE", "M01AE51" ], "active_substances": [ "Ibuprofen", "PSEUDOEPHEDRINE HYDROCHLORIDE" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/338/001", "product_name": "Dostinex 500 microgram Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-10-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02CB", "G02CB03" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/400/001", "product_name": "Sporanox 100 mg Capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J02AC", "J02AC02" ], "active_substances": [ "Itraconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/404/001", "product_name": "Lescol XL 80 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2014-12-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C10AA04" ], "active_substances": [ "Fluvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/405/001", "product_name": "Plendil 5 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-01-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA", "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/405/002", "product_name": "Plendil 10 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA", "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/406/001", "product_name": "Xalacom 50 micrograms/ml + 5 mg/ml, eye drops, solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Latanoprost", "Timolol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/407/002", "product_name": "Actiq 400 micrograms compressed lozenge with integral oromucosal applicator", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-05-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N02AB03" ], "active_substances": [ "Fentanyl" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/409/001", "product_name": "Lipantil Supra 145 mg film-coated tablet", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-05-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AB", "C10AB05" ], "active_substances": [ "Fenofibrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/410/001", "product_name": "Nurofen Plus Tablets Ibuprofen 200 mg Codeine Phosphate Hemihydrate 12.8 mg", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-05-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02AJ", "N02AJ08" ], "active_substances": [ "Ibuprofen", "Codeine phosphate hemihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/413/001", "product_name": "Alphagan 0.2% w/v (2 mg/ml) eye drops, solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-07-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EA05" ], "active_substances": [ "Brimonidine tartrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/415/001", "product_name": "Provigil 100 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-06-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N06BA07" ], "active_substances": [ "Modafinil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/416/001", "product_name": "Dalacin 2% Vaginal Cream", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2015-12-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "J01FF", "J01FF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/418/001", "product_name": "Aldactone 25 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2016-06-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/418/002", "product_name": "Aldactone 100 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/422/001", "product_name": "Dymista 137 micrograms/50 micrograms per actuation nasal spray, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2016-12-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD58" ], "active_substances": [ "Azelastine hydrochloride", "Fluticasone propionate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/423/001", "product_name": "Losec MUPS 20 mg gastro-resistant tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/423/003", "product_name": "Losec MUPS 10 mg gastro-resistant tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/428/001", "product_name": "MOVIPREP, powder for oral solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-04-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD", "A06AD65" ], "active_substances": [ "Sodium ascorbate", "Ascorbic acid", "Potassium chloride", "Sodium chloride", "Sodium sulphate anhydrous", "Macrogol 3350" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/430/001", "product_name": "Nurofen Express Maximum Strength 400 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-08-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/430/002", "product_name": "Nurofen 200 mg coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/432/002", "product_name": "Copaxone 40 mg/ml solution for injection in pre-filled syringe", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "L03AX", "L03AX13" ], "active_substances": [ "Glatiramer acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/433/001", "product_name": "Pulmozyme 2500 U/2.5 ml nebuliser solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2018-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nebuliser solution", "atc_codes": [ "R05CB", "R05CB13" ], "active_substances": [ "Dornase alfa" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/435/001", "product_name": "Prograf 0.5 mg hard capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/435/002", "product_name": "Prograf 1 mg hard capsules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be 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"Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/436/004", "product_name": "Metoject 20 mg solution for injection in pre-filled pen", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-04-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA", "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/436/005", "product_name": "Metoject 25 mg solution for injection in 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"2017-12-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AD", "D10AD03" ], "active_substances": [ "Adapalene" ], "routes": [ "Cutaneous use", "Topical" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/438/001", "product_name": "Seroquel XR 50 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies 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"registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/438/004", "product_name": "Seroquel XR 300 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2017-12-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/438/005", "product_name": "Seroquel 25 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2020-12-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/438/006", "product_name": "Seroquel 100 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2020-12-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/438/007", "product_name": "Seroquel XR 400 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/441/001", "product_name": "Crestor 5 mg 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], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/441/003", "product_name": "Crestor 20 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2018-10-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/441/004", "product_name": "Crestor 40 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2018-10-12", "product_type": "HM", "market_status": "Unknown", 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"product_name": "Lamictal 100 mg chewable/dispersible tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2012-09-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/445/001", "product_name": "Zofran Zydis 4 mg oral lyophilisate", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2019-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ 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"authorised_date": "2019-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA02" ], "active_substances": [ "Hydrochlorothiazide", "Eprosartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/449/001", "product_name": "Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2019-05-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01EE", "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject 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"product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/450/004", "product_name": "Pentasa Sachet 4 g prolonged-release granules", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-05-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies 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"G03FA", "G03FA14" ], "active_substances": [ "Dydrogesterone", "Estradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/464/002", "product_name": "Femoston-conti 0.5 mg/2.5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA", "G03FA14" ], "active_substances": [ "Estradiol", "Dydrogesterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 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"dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Enalapril maleate", "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/472/002", "product_name": "Lercaril 20 mg/10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-04-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Enalapril maleate", "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/472/003", "product_name": "Lercaril 20 mg/20 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Enalapril maleate", "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/473/001", "product_name": "PROSTAP 3 DCS 11.25 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-12-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection in pre-filled syringe", "atc_codes": [ "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/474/001", "product_name": "Zanaflex 2 mg Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-05-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX02" ], "active_substances": [ "Tizanidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed 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"market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution in single-dose container", "atc_codes": [ "S01ED", "S01ED51" ], "active_substances": [ "Tafluprost", "Timolol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/477/001", "product_name": "Clexane 10,000 IU (100 mg)/1 ml Solution for Injection in pre-filled syringes", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-08-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Intravenous use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to 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Solution for Injection in pre-filled syringes", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/477/004", "product_name": "Clexane 8,000 IU (80 mg) /0.8 ml Solution for Injection in pre-filled syringes", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/477/005", "product_name": "Clexane Forte 12,000 IU (120 mg)/0.8 ml Solution for Injection in pre-filled syringes", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-11-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "B01AB05" ], "active_substances": [ "Enoxaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/478/001", "product_name": "Somatuline Autogel 120 mg, solution for injection in a pre-filled syringe", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-09-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB", "H01CB03" ], "active_substances": [ "Lanreotide acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/481/001", "product_name": "Zanidip 10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/481/002", "product_name": "Zanidip 20 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA", "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/482/001", "product_name": "Serc 16 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07CA", "N07CA01" ], "active_substances": [ "Betahistine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/485/001", "product_name": "Monuril 3 g granules for oral solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-01-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "J01XX", "J01XX01" ], "active_substances": [ "Fosfomycin trometamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "" }, { "licence_number": "PPA0465/488/001", "product_name": "Solaraze 3% gel", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2021-12-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D11AX18" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/489/001", "product_name": "Evorel Conti 50/170 micrograms per 24 hours transdermal patch", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "G03FA01" ], "active_substances": [ "Estradiol", "Norethisterone acetate" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/491/001", "product_name": "Relpax 40 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC06" ], "active_substances": [ "ELETRIPTAN" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/492/001", "product_name": "Mestinon 60 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07AA", "N07AA02" ], "active_substances": [ "Pyridostigmine bromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/494/001", "product_name": "Kemadrin 5 mg tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-09-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04AA", "N04AA04" ], "active_substances": [ "Procyclidine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/495/001", "product_name": "Foznol 1000 mg Chewable Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2022-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "V03AE", "V03AE03" ], "active_substances": [ "Lanthanum" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/496/001", "product_name": "Zyban 150 mg prolonged release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-02-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06AX", "N06AX12" ], "active_substances": [ "Bupropion hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/499/001", "product_name": "innohep 4,500 IU, solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-03-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/499/002", "product_name": "innohep 3,500 IU, solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/499/003", "product_name": "innohep 10,000 IU in 0.5 ml, solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/499/004", "product_name": "innohep 14,000 IU in 0.7 ml, solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/499/005", "product_name": "innohep 18,000 IU in 0.9 ml, solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2023-06-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB", "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/501/001", "product_name": "Humulin M3 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prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/506/001", "product_name": "Saizen 8 mg/ml solution for injection in cartridge", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/507/001", "product_name": "Ryaltris 25 microgram/actuation + 600 microgram/actuation nasal spray, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-07-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD59" ], "active_substances": [ "Mometasone furoate", "Olopatadine" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/508/001", "product_name": "Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/508/002", "product_name": "Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/509/001", "product_name": "Propranolol 10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-10-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AA05" ], "active_substances": [ "Propranolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/509/002", "product_name": "Propranolol 40 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-10-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C07AA05" ], "active_substances": [ "Propranolol hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/510/001", "product_name": "Clarityn 10 mg Tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/511/001", "product_name": "ELIGARD 22.5 mg powder and solvent for solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-01-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/511/002", "product_name": "ELIGARD 45 mg powder and solvent for solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-01-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/512/001", "product_name": "Targin 5 mg/2.5 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA55" ], "active_substances": [ "Oxycodone hydrochloride", "Naloxone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/512/002", "product_name": "Targin 10 mg/5 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA55" ], "active_substances": [ "Oxycodone hydrochloride", "Naloxone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/512/003", "product_name": "Targin 20 mg/10 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-03-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA55" ], "active_substances": [ "Oxycodone hydrochloride", "Naloxone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/512/004", "product_name": "Targin 40 mg/20 mg prolonged-release tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N02AA55" ], "active_substances": [ "Oxycodone hydrochloride", "Naloxone hydrochloride dihydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/513/001", "product_name": "Coverdine 5 mg/1.25 mg/5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/513/002", "product_name": "Coverdine 5 mg/1.25 mg/10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/513/003", "product_name": "Coverdine 10 mg/2.5 mg/5 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/513/004", "product_name": "Coverdine 10 mg/2.5 mg/10 mg film-coated tablets", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-01-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine" ], "routes": [], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/514/001", "product_name": "Sandostatin LAR 10 mg powder and solvent for suspension for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/514/002", "product_name": "Sandostatin LAR 20 mg powder and solvent for suspension for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/514/003", "product_name": "Sandostatin LAR 30 mg powder and solvent for suspension for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "H01CB02" ], "active_substances": [ "Octreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/515/001", "product_name": "Alvesco 160 microgram pressurised inhalation, solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA08" ], "active_substances": [ "Ciclesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/516/001", "product_name": "Kyleena 19.5 mg intrauterine delivery system", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/517/001", "product_name": "Duac Once Daily 10 mg/g + 50 mg/g gel", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-08-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AF51" ], "active_substances": [ "Clindamycin", "Anhydrous Benzoyl Peroxide" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/518/001", "product_name": "Nebido 1000 mg/4 ml, solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-08-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "G03BA03" ], "active_substances": [ "Testosterone Undecanoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA0465/519/001", "product_name": "Epiduo 0.1%/2.5% gel", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-11-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AD53" ], "active_substances": [ "Adapalene", "Benzoyl Peroxide" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/520/001", "product_name": "Xalatan 50 micrograms/mL Eye drops, solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EE01" ], "active_substances": [ "Latanoprost" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/521/001", "product_name": "BOTOX 100 Allergan Units powder for solution for injection", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-01-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for solution for injection", "atc_codes": [ "M03AX01" ], "active_substances": [ "Botulinum toxin type A" ], "routes": [ "Intradermal use", "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/522/001", "product_name": "Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-02-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for cutaneous solution", "atc_codes": [ "D10AF52" ], "active_substances": [ "Erythromycin", "Zinc acetate dihydrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/523/001", "product_name": "Norditropin FlexPro 5 mg/1.5 ml solution for injection in pre-filled pen", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/523/002", "product_name": "Norditropin FlexPro 10 mg/1.5 ml solution for injection in pre-filled pen", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/523/003", "product_name": "Norditropin FlexPro 15 mg/1.5 ml solution for injection in pre-filled pen", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-04-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "H01AC01" ], "active_substances": [ "Somatropin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/524/001", "product_name": "Lubion 25 mg solution for injection in pre-filled syringe", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-06-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA0465/525/001", "product_name": "RISPERDAL 1 mg/ml oral solution", "holder": "PCO Manufacturing Ltd.", "authorised_date": "2026-05-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/002/001", "product_name": "Nexium 20 mg gastro-resistant tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2008-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/002/002", "product_name": "Nexium 40 mg gastro-resistant tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2008-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/006/001", "product_name": "Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder, pre-dispensed", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2009-01-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/006/002", "product_name": "Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-02-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Fluticasone propionate", "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/006/003", "product_name": "Seretide 100 Diskus 50 microgram/100 microgram/dose inhalation powder, pre-dispensed", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-02-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK", "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/006/006", "product_name": "Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/025/001", "product_name": "Omnexel 400 micrograms prolonged release tablets, film-coated", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "G04CA", "G04CA02" ], "active_substances": [ "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/029/001", "product_name": "Cozaar 50 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/029/002", "product_name": "Cozaar 100 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA01" ], "active_substances": [ "Losartan potassium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/031/001", "product_name": "Atacand 8 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-02-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA", "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/031/002", "product_name": "Atacand 16 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-02-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09CA06" ], "active_substances": [ "Candesartan cilexetil" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/033/002", "product_name": "Creon 25000 Gastro-resistant capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2013-01-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Not Currently Available", "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/041/001", "product_name": "Arcoxia 60 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/041/002", "product_name": "Arcoxia 90 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-08-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "M01AH05" ], "active_substances": [ "Etoricoxib" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/042/001", "product_name": "Omacor 1000 mg Soft Capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "C10AX", "C10AX06" ], "active_substances": [ "Omega-3-acid ethyl esters" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/043/001", "product_name": "Co-Diovan 80 mg/12.5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Hydrochlorothiazide", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/043/002", "product_name": "Co-Diovan 160 mg/12.5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Valsartan", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/043/003", "product_name": "Co-Diovan 160 mg/25 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-09-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA03" ], "active_substances": [ "Hydrochlorothiazide", "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/053/001", "product_name": "Atacand Plus 16 mg/12.5 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-10-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09DA06" ], "active_substances": [ "Candesartan cilexetil", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/060/001", "product_name": "COSOPT 20 mg/ml + 5 mg/ml eye drops, solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-04-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01ED51" ], "active_substances": [ "Timolol", "Dorzolamide" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/064/002", "product_name": "Singulair Paediatric 5 mg Chewable Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "R03DC", "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/064/003", "product_name": "Singulair 10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-05-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "R03DC03" ], "active_substances": [ "Montelukast" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/001", "product_name": "Lamictal 50 mg chewable/dispersible tablets.", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/002", "product_name": "Lamictal 100 mg chewable/dispersible tablets.", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/003", "product_name": "Lamictal 200 mg chewable/dispersible tablets.", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-08-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/004", "product_name": "Lamictal 25 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/005", "product_name": "Lamictal 100 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/006", "product_name": "Lamictal 25 mg chewable/dispersible tablets.", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-08-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable/dispersible tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/008", "product_name": "Lamictal 50 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/066/009", "product_name": "Lamictal 200 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/067/001", "product_name": "Zineryt 40 mg + 12 mg powder and solvent for cutaneous solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-11-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for cutaneous solution", "atc_codes": [ "D10AF52" ], "active_substances": [ "Erythromycin", "Zinc acetate dihydrate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/068/001", "product_name": "Combodart 0.5 mg/ 0.4 mg hard capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-10-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA", "G04CA52" ], "active_substances": [ "Dutasteride", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/069/001", "product_name": "Aromasin 25 mg coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-08-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "L02BG", "L02BG06" ], "active_substances": [ "Exemestane" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/070/001", "product_name": "Arimidex 1 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-09-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG", "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/081/001", "product_name": "Loceryl 5% w/v Medicated Nail Lacquer", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2013-10-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicated nail lacquer", "atc_codes": [ "D01AE", "D01AE16" ], "active_substances": [ "Amorolfine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/093/001", "product_name": "Mezavant XL 1200 mg gastro-resistant, prolonged release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-02-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/098/001", "product_name": "Triapin 5 mg/5 mg prolonged release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-08-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C09BB", "C09BB05" ], "active_substances": [ "Felodipine", "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/101/001", "product_name": "Lescol XL 80 mg Prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C10AA04" ], "active_substances": [ "Fluvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/102/001", "product_name": "NASONEX 50 micrograms/actuation Nasal Spray, Suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2015-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD09" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/107/001", "product_name": "Casodex 50 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2016-04-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BB", "L02BB03" ], "active_substances": [ "Bicalutamide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/110/001", "product_name": "Pentasa 500 mg prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2016-07-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/110/002", "product_name": "Pentasa 1 g prolonged-release tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2022-12-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/111/001", "product_name": "Mirena 52 mg Intrauterine Delivery System", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2017-03-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA", "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/112/001", "product_name": "Crinone 8% w/w progesterone vaginal gel", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2017-03-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Vaginal gel", "atc_codes": [ "G03DA04" ], "active_substances": [ "Progesterone" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/119/001", "product_name": "Crestor 5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2018-04-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/119/002", "product_name": "Crestor 10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2018-04-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/119/003", "product_name": "Crestor 20 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2018-04-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/119/004", "product_name": "Crestor 40 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-02-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA", "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/120/001", "product_name": "Differin 0.1% w/w cream", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D10AD", "D10AD03" ], "active_substances": [ "Adapalene" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/120/002", "product_name": "Differin 0.1% w/w gel", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D10AD", "D10AD03" ], "active_substances": [ "Adapalene" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/125/001", "product_name": "Zoladex 3.6 mg implant", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "L02AE", "L02AE03" ], "active_substances": [ "Goserelin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/125/002", "product_name": "Zoladex LA 10.8 mg implant", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "L02AE", "L02AE03" ], "active_substances": [ "Goserelin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/126/001", "product_name": "Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-09-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/126/002", "product_name": "Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/127/001", "product_name": "Proscar 5 mg Film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-11-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04CB", "G04CB01" ], "active_substances": [ "Finasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/128/001", "product_name": "Puri-Nethol 50 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2019-11-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L01BB02" ], "active_substances": [ "Mercaptopurine monohydrate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/130/001", "product_name": "Vesitirim 5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/130/002", "product_name": "Vesitirim 10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2010-11-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G04BD", "G04BD08" ], "active_substances": [ "Solifenacin succinate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/133/001", "product_name": "Tetralysal 300 mg hard capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2013-04-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01AA", "J01AA04" ], "active_substances": [ "Tetracycline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/135/001", "product_name": "Versatis 700 mg medicated plaster", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2012-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/136/001", "product_name": "TOPAMAX 100 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-02-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/136/002", "product_name": "TOPAMAX 25 mg Film-coated Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/136/003", "product_name": "TOPAMAX 50 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-02-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/136/004", "product_name": "Topamax 200 mg Film-coated Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/138/001", "product_name": "Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2020-10-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/138/002", "product_name": "Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AK", "R03AK11" ], "active_substances": [ "Fluticasone propionate", "Formoterol fumarate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/139/001", "product_name": "Vesomni 6 mg/0.4 mg modified-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2020-09-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "G04CA53" ], "active_substances": [ "Solifenacin succinate", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/141/001", "product_name": "Losec MUPS 20 mg gastro-resistant tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2006-09-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/141/002", "product_name": "Losec MUPS 10 mg gastro-resistant tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC01" ], "active_substances": [ "Omeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/142/002", "product_name": "Spiriva Respimat 2.5 microgram inhalation solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2011-09-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation solution", "atc_codes": [ "R03BB04" ], "active_substances": [ "Tiotropium" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/143/001", "product_name": "Regurin 20 mg coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2007-11-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G04BD", "G04BD09" ], "active_substances": [ "Trospium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/144/001", "product_name": "Ursofalk 250 mg Hard Capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2009-07-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "A05AA", "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/144/002", "product_name": "Ursofalk 500 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-06-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A05AA02" ], "active_substances": [ "Ursodeoxycholic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/145/001", "product_name": "Creon 10000 Gastro-Resistant Capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2008-02-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant capsule, hard", "atc_codes": [ "A09AA", "A09AA02" ], "active_substances": [ "Pancreatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/147/001", "product_name": "Celluvisc 1.0% w/v Eye drops, solution, unit dose", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2009-08-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01XA20" ], "active_substances": [ "Carmellose sodium" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/149/001", "product_name": "Avodart 0.5 mg soft capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2009-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "G04CB02" ], "active_substances": [ "Dutasteride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/150/001", "product_name": "Dalacin C 150 mg Hard Capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2014-08-29", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FF", "J01FF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/154/001", "product_name": "Trileptal 60 mg/ml Oral Suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/154/002", "product_name": "Trileptal 300 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/154/003", "product_name": "Trileptal 600 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-01-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AF", "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/157/001", "product_name": "Lamisil 250 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-02-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "D01BA", "D01BA02" ], "active_substances": [ "Terbinafine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/158/002", "product_name": "Zofran 4 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2022-03-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/158/003", "product_name": "Zofran 8 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2022-03-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/159/001", "product_name": "Arthrotec 75 modified-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AB", "M01AB55" ], "active_substances": [ "Diclofenac sodium", "Misoprostol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/160/001", "product_name": "Midon 2.5 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-08-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA", "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/161/001", "product_name": "Megace 40 mg/ml Oral Suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "L02AB", "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/162/001", "product_name": "Dostinex 500 microgram tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02CB", "G02CB03" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/163/001", "product_name": "Requip-Modutab 2 mg Prolonged-Release Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/163/002", "product_name": "Requip-Modutab 4 mg Prolonged-Release Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/163/003", "product_name": "Requip-Modutab 8 mg Prolonged-Release Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-05-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/164/001", "product_name": "Dianette 2 mg/35 microgram coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-06-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "G03HB", "G03HB01" ], "active_substances": [ "Cyproterone acetate", "Ethinylestradiol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/165/001", "product_name": "Prograf 0.5 mg hard capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/165/002", "product_name": "Prograf 5 mg hard capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "L04AD02" ], "active_substances": [ "Tacrolimus" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/166/001", "product_name": "Famvir 250 mg Film-Coated Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/166/002", "product_name": "Famvir 500 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB09" ], "active_substances": [ "Famciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/167/001", "product_name": "One-Alpha 1 microgram soft capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-05-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "A11CC", "A11CC03" ], "active_substances": [ "Alfacalcidol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/168/001", "product_name": "Zomig 2.5 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC03" ], "active_substances": [ "Zolmitriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/168/002", "product_name": "Zomig Rapimelt 2.5 mg orodispersible Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-06-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "N02CC", "N02CC03" ], "active_substances": [ "Zolmitriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/169/001", "product_name": "Trosyl 283 mg/ml Nail Solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-08-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D01AC", "D01AC07" ], "active_substances": [ "Tioconazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/170/001", "product_name": "Xyzal 0.5 mg/ml oral solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-08-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE09" ], "active_substances": [ "Levocetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/171/001", "product_name": "Implanon NXT, 68 mg implant for subdermal use", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "G03AC08" ], "active_substances": [ "Etonogestrel" ], "routes": [ "Implantation" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/173/001", "product_name": "Valtrex 500 mg Film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-04-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J05AB", "J05AB11" ], "active_substances": [ "Valaciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/174/001", "product_name": "Desmotabs Melt 120 micrograms oral lyophilisate", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "H01BA02" ], "active_substances": [ "DESMOPRESSIN ACETATE" ], "routes": [ "Sublingual use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/175/001", "product_name": "Alvesco 160 micrograms pressurised inhalation, solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-01-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, solution", "atc_codes": [ "R03BA", "R03BA08" ], "active_substances": [ "Ciclesonide" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/177/001", "product_name": "Campral EC 333 mg Gastro-resistant tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "N07BB", "N07BB03" ], "active_substances": [ "Acamprosate calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/181/001", "product_name": "Zarontin 250 mg/5 ml Syrup", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-07-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N03AD", "N03AD01" ], "active_substances": [ "Ethosuximide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/182/001", "product_name": "Seroquel 25 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-07-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/182/002", "product_name": "Seroquel 100 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-07-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/182/003", "product_name": "Seroquel XR 50 mg prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA1463/182/004", "product_name": "Seroquel XR 200 mg prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH", "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/183/001", "product_name": "Plendil 5 mg prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2021-09-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA", "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/183/002", "product_name": "Plendil 10 mg prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C08CA02" ], "active_substances": [ "Felodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/185/001", "product_name": "Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-01-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation solution", "atc_codes": [ "R03BB", "R03BB54" ], "active_substances": [ "Olodaterol", "Tiotropium" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/186/001", "product_name": "Kyleena 19.5 mg intrauterine delivery system", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-02-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Intrauterine delivery system", "atc_codes": [ "G02BA", "G02BA03" ], "active_substances": [ "Levonorgestrel" ], "routes": [ "Intrauterine use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/187/001", "product_name": "Ezetrol 10 mg tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2022-02-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C10AX", "C10AX09" ], "active_substances": [ "Ezetimibe" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/189/001", "product_name": "Femoston-conti 1 mg/5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-12-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "G03FA14" ], "active_substances": [ "Estradiol", "Dydrogesterone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/190/001", "product_name": "Pentasa Sachet 2 g prolonged-release granules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-03-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/190/002", "product_name": "Pentasa Sachet 4 g prolonged-release granules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-11-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/190/003", "product_name": "Pentasa 1 g Suppositories", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-05-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/191/001", "product_name": "Megace 160 mg Tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2022-04-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "L02AB", "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/192/001", "product_name": "Lamisil 1% w/w cream", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-07-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D01A", "D01AE15" ], "active_substances": [ "Terbinafine hydrochloride" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/193/001", "product_name": "Dexafree 1 mg/ml eye drops, solution in single dose container", "holder": "IMED Healthcare Ltd.", "authorised_date": "2022-05-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01BA", "S01BA01" ], "active_substances": [ "DEXAMETHASONE PHOSPHATE" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/196/001", "product_name": "Imuran 50 mg Film-coated Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-11-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/196/002", "product_name": "Imuran 25 mg Film-coated Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L04AX01" ], "active_substances": [ "Azathioprine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/197/001", "product_name": "Fucibet Lipid 20mg/g + 1mg/g cream", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-02-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D07CC", "D07CC01" ], "active_substances": [ "Fusidic acid", "Betamethasone" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/198/001", "product_name": "Lercaril 10 mg/10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-11-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Lercanidipine hydrochloride", "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/198/002", "product_name": "Lercaril 20 mg/10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-05-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB", "C09BB02" ], "active_substances": [ "Lercanidipine hydrochloride", "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/198/003", "product_name": "Lercaril 20 mg/20 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-08-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BB02" ], "active_substances": [ "Enalapril maleate", "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/199/001", "product_name": "Zovirax 200 mg Dispersible Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2022-12-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/199/004", "product_name": "Zovirax 5% w/w Cream", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-12-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D06BB03" ], "active_substances": [ "Acyclovir" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/200/001", "product_name": "Acular 0.5% w/v Eye Drops, solution", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-01-13", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01BC", "S01BC05" ], "active_substances": [ "Ketorolac trometamol" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/203/001", "product_name": "Zanidip 10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-07-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/203/002", "product_name": "Zanidip 20 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-02-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C08CA13" ], "active_substances": [ "Lercanidipine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/204/001", "product_name": "Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-01-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03AC12" ], "active_substances": [ "Salmeterol" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/205/001", "product_name": "Solaraze 3% gel", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-03-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "D11AX18" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/206/001", "product_name": "DiproSalic 0.05% w/w + 2% w/w scalp application", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cutaneous solution", "atc_codes": [ "D07XC", "D07XC01" ], "active_substances": [ "Betamethasone dipropionate", "Salicylic acid" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/207/001", "product_name": "Imodium Instants 2 mg Orodispersible Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Orodispersible tablet", "atc_codes": [ "A07DA", "A07DA03" ], "active_substances": [ "Loperamide hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/208/001", "product_name": "Innovace 10 mg tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/208/002", "product_name": "Innovace 20 mg tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-07-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C09AA", "C09AA02" ], "active_substances": [ "Enalapril maleate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/210/001", "product_name": "Nicorette Invisi 10 mg/16 hours Transdermal Patch", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07AB01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/210/002", "product_name": "Nicorette Invisi 15 mg/16 hours Transdermal Patch", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/210/003", "product_name": "Nicorette Invisi Extra Strength 25 mg/16 hours Transdermal Patch", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-09-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal patch", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/211/001", "product_name": "Imigran 20 mg nasal spray, solution", "holder": "IMED Healthcare Ltd.", "authorised_date": "2023-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, solution", "atc_codes": [ "N02CC", "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/211/002", "product_name": "Imigran Ftab 50 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC01" ], "active_substances": [ "Sumatriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/212/001", "product_name": "Salofalk 1g Suppositories", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-08-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/213/001", "product_name": "Monuril 3 g granules for oral solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-10-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Granules for oral solution", "atc_codes": [ "J01XX01" ], "active_substances": [ "Fosfomycin trometamol" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/214/001", "product_name": "Zirtek 1 mg/ml oral solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-08-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "R06AE07" ], "active_substances": [ "Cetirizine dihydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/215/001", "product_name": "Atozet 10 mg/40 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/215/002", "product_name": "Atozet 10 mg/80 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2023-10-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/215/003", "product_name": "Atozet 10 mg/10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10BA05" ], "active_substances": [ "Ezetimibe", "Atorvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/217/001", "product_name": "Nurofen Express Maximum Strength 400 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "M01AE", "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/218/001", "product_name": "Calcichew 500 mg Chewable Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-06-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Chewable tablet", "atc_codes": [ "A12AA04" ], "active_substances": [ "Calcium carbonate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/220/001", "product_name": "Nurofen Rapid Relief Maximum Strength 400 mg Liquid Capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-01-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [ "M01AE01" ], "active_substances": [ "Ibuprofen" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/221/001", "product_name": "Voltarol Emulgel Extra Strength 2% w/w gel", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-01-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "M02AA", "M02AA15" ], "active_substances": [ "Diclofenac sodium" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/222/001", "product_name": "Clarityn 10 mg tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-06-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX13" ], "active_substances": [ "Loratadine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/223/001", "product_name": "Aldactone 25 mg Film-coated Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/223/002", "product_name": "Aldactone 100 mg Film-coated tablet", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-05-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C03DA01" ], "active_substances": [ "Spironolactone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA1463/224/001", "product_name": "Zanaflex 2 mg Tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX02" ], "active_substances": [ "Tizanidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/224/002", "product_name": "Zanaflex 4 mg Tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "M03BX", "M03BX02" ], "active_substances": [ "Tizanidine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/225/001", "product_name": "Cozaar Comp 100mg/12.5mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-07-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/225/002", "product_name": "Cozaar Comp 100mg/25mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-07-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09DA", "C09DA01" ], "active_substances": [ "Losartan potassium", "Hydrochlorothiazide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/226/001", "product_name": "Canesten Thrush Cream", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G01AF", "G01AF02" ], "active_substances": [ "Clotrimazole" ], "routes": [ "Topical use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/227/001", "product_name": "RISPERDAL 1 mg/ml oral solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-05-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/228/001", "product_name": "Diovan 80 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/228/002", "product_name": "Diovan 160 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09CA03" ], "active_substances": [ "Valsartan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/229/001", "product_name": "Zyban 150 mg prolonged-release tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-09-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06AX12" ], "active_substances": [ "Bupropion hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(4) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/232/001", "product_name": "Moviprep, powder for oral solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium sulfate anhydrous", "Sodium chloride", "Potassium chloride", "Ascorbic acid", "Sodium ascorbate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/233/001", "product_name": "Myfortic 360 mg gastro-resistant tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2024-09-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "L04AA06" ], "active_substances": [ "Mycophenolic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/234/001", "product_name": "Septrin 80 mg/400 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2024-12-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "J01EE01" ], "active_substances": [ "Sulfamethoxazole", "Trimethoprim" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/235/001", "product_name": "Sinemet Plus 25 mg/100 mg tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-02-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04BA02" ], "active_substances": [ "Carbidopa", "Levodopa" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/236/001", "product_name": "Nordurine 0.2 mg Tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-03-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "H01BA02" ], "active_substances": [ "Desmopressin acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/237/001", "product_name": "Coverdine 10 mg/2.5 mg/10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/237/002", "product_name": "Coverdine 5 mg/1.25 mg/5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/237/003", "product_name": "Coverdine 5 mg/1.25 mg/10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/237/004", "product_name": "Coverdine 10 mg/2.5 mg/5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine besilate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/238/001", "product_name": "Neotigason 10 mg capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-07-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "D05BB02" ], "active_substances": [ "Acitretin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/239/001", "product_name": "Elocon 0.1% w/w Ointment", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-03-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Ointment", "atc_codes": [ "D07AC13" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/240/001", "product_name": "Metoject 10 mg solution for injection in pre-filled pen", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/240/002", "product_name": "Metoject 15 mg solution for injection in pre-filled pen", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled pen", "atc_codes": [ "L01BA01" ], "active_substances": [ "Methotrexate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/241/001", "product_name": "Lexapro 5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/241/002", "product_name": "Lexapro 10 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/241/003", "product_name": "Lexapro 15 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/241/004", "product_name": "Lexapro 20 mg film-coated tablets", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N06AB10" ], "active_substances": [ "Escitalopram" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/242/001", "product_name": "Augmentin 875 mg/125 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-04-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "J01CR02" ], "active_substances": [ "Amoxicillin", "Clavulanic acid" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/245/001", "product_name": "Rectogesic 4 mg/g Rectal Ointment", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-04-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Rectal ointment", "atc_codes": [ "C05AE01" ], "active_substances": [ "Glyceryl trinitrate" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/246/001", "product_name": "Sporanox 100 mg Capsules", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-05-30", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule", "atc_codes": [ "J02AC02" ], "active_substances": [ "Itraconazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/247/001", "product_name": "Soolantra 10 mg/g Cream", "holder": "IMED Healthcare Ltd.", "authorised_date": "2025-09-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cream", "atc_codes": [ "D11AX22" ], "active_substances": [ "Ivermectin" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/248/001", "product_name": "Ovestin 1 mg per gram Vaginal Cream", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-09-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Vaginal cream", "atc_codes": [ "G03CA04" ], "active_substances": [ "Estriol" ], "routes": [ "Vaginal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/251/001", "product_name": "Innohep 3,500 IU, solution for injection", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/251/002", "product_name": "Innohep 4,500 IU, solution for injection", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/251/003", "product_name": "Innohep 10,000 IU in 0.5 ml, solution for injection", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/251/004", "product_name": "Innohep 14,000 IU in 0.7 ml, solution for injection", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection", "atc_codes": [ "B01AB10" ], "active_substances": [ "Tinzaparin sodium" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/252/001", "product_name": "Alphagan 0.2% w/v (2 mg/ml) eye drops, solution", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Eye drops, solution", "atc_codes": [ "S01EA05" ], "active_substances": [ "Brimonidine tartrate" ], "routes": [ "Ocular use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/253/001", "product_name": "RELPAX 40 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-11-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC06" ], "active_substances": [ "Eletriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/255/001", "product_name": "Cordarone X 200 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2025-12-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01BD01" ], "active_substances": [ "Amiodarone hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/260/001", "product_name": "Flixotide Evohaler 125 micrograms per metered dose Pressurised Inhalation Suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/260/002", "product_name": "Flixotide Evohaler 250 micrograms per metered dose Pressurised Inhalation Suspension", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pressurised inhalation, suspension", "atc_codes": [ "R03BA05" ], "active_substances": [ "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/261/001", "product_name": "Nicotinell Mint 1 mg compressed lozenge", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-06-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Compressed lozenge", "atc_codes": [ "N07BA01" ], "active_substances": [ "Nicotine bitartrate dihydrate" ], "routes": [ "Oromucosal use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/262/001", "product_name": "FROVEX 2.5 mg film-coated tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-07-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N02CC07" ], "active_substances": [ "Frovatriptan" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/263/001", "product_name": "Drynol 20 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-08-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "R06AX29" ], "active_substances": [ "Bilastine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/264/001", "product_name": "Asacolon 800 mg Gastro-resistant Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-08-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/265/001", "product_name": "Enstilar 50 micrograms/g + 0.5 mg/g cutaneous foam", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-09-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Cutaneous foam", "atc_codes": [ "D05AX", "D05AX52" ], "active_substances": [ "Calcipotriol", "Betamethasone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1463/266/001", "product_name": "Kemadrin 5 mg Tablets", "holder": "IMED Healthcare Ltd.,", "authorised_date": "2026-09-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N04AA04" ], "active_substances": [ "Procyclidine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA1925/002/001", "product_name": "Movicol 13.8g sachet, powder for oral solution", "holder": "Novalus Healthcare Limited", "authorised_date": "2017-03-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder for oral solution", "atc_codes": [ "A06AD65" ], "active_substances": [ "Macrogol 3350", "Sodium bicarbonate", "Sodium chloride", "Potassium chloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/001/001", "product_name": "Femara 2.5 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2018-09-14", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG04" ], "active_substances": [ "Letrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/002/001", "product_name": "Requip-Modutab 8 mg prolonged-release tablets", "holder": "Originalis B.V.", "authorised_date": "2018-11-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/002/002", "product_name": "Requip-Modutab 4 mg prolonged-release tablets", "holder": "Originalis B.V.", "authorised_date": "2019-01-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N04BC04" ], "active_substances": [ "Ropinirole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/003/001", "product_name": "Topamax 200 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX", "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/003/002", "product_name": "TOPAMAX 100 mg Film-coated Tablets", "holder": "Originalis B.V.", "authorised_date": "2025-12-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA2306/004/001", "product_name": "Trileptal 60 mg/ml Oral Suspension", "holder": "Originalis B.V.", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "N03AF02" ], "active_substances": [ "Oxcarbazepine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/005/001", "product_name": "Zyban 150 mg prolonged release tablets", "holder": "Originalis B.V.", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N06AX12" ], "active_substances": [ "Bupropion hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/006/001", "product_name": "Zofran Zydis 4 mg oral lyophilisate", "holder": "Originalis B.V.", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral lyophilisate", "atc_codes": [ "A04AA", "A04AA01" ], "active_substances": [ "Ondansetron" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/007/001", "product_name": "RISPERDAL 1 mg/ml oral solution", "holder": "Originalis B.V.", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N05AX08" ], "active_substances": [ "Risperidone" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/008/001", "product_name": "Reminyl XL 16 mg prolonged-release capsules, hard", "holder": "Originalis B.V.", "authorised_date": "2019-01-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/009/001", "product_name": "Reminyl XL 24 mg prolonged-release capsules, hard", "holder": "Originalis B.V.", "authorised_date": "2018-12-07", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release capsule, hard", "atc_codes": [ "N06DA", "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/010/001", "product_name": "Pentasa 1 g suppositories", "holder": "Originalis B.V.", "authorised_date": "2019-02-01", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Suppository", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Rectal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/010/002", "product_name": "Pentasa Sachet 2g prolonged-release granules", "holder": "Originalis B.V.", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release granules", "atc_codes": [ "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/011/001", "product_name": "Seroquel XR 400 mg prolonged-release tablets", "holder": "Originalis B.V.", "authorised_date": "2019-02-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/011/002", "product_name": "Seroquel XR 150 mg prolonged-release tablets", "holder": "Originalis B.V.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "N05AH04" ], "active_substances": [ "Quetiapine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/012/001", "product_name": "REMINYL 4 mg/ml oral solution", "holder": "Originalis B.V.", "authorised_date": "2018-12-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral solution", "atc_codes": [ "N06DA04" ], "active_substances": [ "Galantamine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/015/001", "product_name": "Aromasin 25 mg coated tablets", "holder": "Originalis B.V.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Coated tablet", "atc_codes": [ "L02BG06" ], "active_substances": [ "Exemestane" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/016/001", "product_name": "Megace 40 mg/ml oral suspension", "holder": "Originalis B.V.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Oral suspension", "atc_codes": [ "L02AB01" ], "active_substances": [ "Megestrol acetate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "" }, { "licence_number": "PPA2306/017/001", "product_name": "Arimidex 1 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2019-07-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "L02BG03" ], "active_substances": [ "Anastrozole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/019/001", "product_name": "Solian 400 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2019-08-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05AL05" ], "active_substances": [ "Amisulpride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/020/001", "product_name": "Neotigason 25 mg capsules", "holder": "Originalis B.V.", "authorised_date": "2019-11-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "D05BB", "D05BB02" ], "active_substances": [ "Acitretin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/021/001", "product_name": "CosmoFer 50 mg/ml solution for infusion and injection", "holder": "Originalis B.V.", "authorised_date": "2019-10-18", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection/infusion", "atc_codes": [ "B03AC" ], "active_substances": [ "IRON (III)" ], "routes": [ "Intramuscular use", "Intravenous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/022/001", "product_name": "Decapeptyl 3-month, 11.25 mg Powder and solvent for suspension for injection", "holder": "Originalis B.V.", "authorised_date": "2020-05-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use", "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/022/002", "product_name": "Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection", "holder": "Originalis B.V.", "authorised_date": "2026-09-24", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/023/001", "product_name": "Mezavant XL 1200 mg gastro-resistant, prolonged release tablets", "holder": "Originalis B.V.", "authorised_date": "2022-05-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "A07EC", "A07EC02" ], "active_substances": [ "Mesalazine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/024/001", "product_name": "Lamictal 100 mg tablets", "holder": "Originalis B.V.", "authorised_date": "2022-08-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/025/001", "product_name": "Nexium 20 mg gastro-resistant tablets", "holder": "Originalis B.V.", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/025/002", "product_name": "Nexium 40 mg gastro-resistant tablets", "holder": "Originalis B.V.", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC", "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/026/001", "product_name": "Somatuline Autogel 60 mg, solution for injection in a prefilled syringe", "holder": "Originalis B.V.", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB", "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/026/002", "product_name": "Somatuline Autogel 120 mg solution for injection in a pre-filled syringe", "holder": "Originalis B.V.", "authorised_date": "2023-02-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Solution for injection in pre-filled syringe", "atc_codes": [ "H01CB", "H01CB03" ], "active_substances": [ "Lanreotide" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/027/001", "product_name": "Zoladex LA 10.8 mg Implant", "holder": "Originalis B.V.", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Implant", "atc_codes": [ "L02AE", "L02AE03" ], "active_substances": [ "Goserelin" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/028/001", "product_name": "Coverdine 10mg/2.5mg/10mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2022-12-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C09BX", "C09BX01" ], "active_substances": [ "Perindopril arginine", "Indapamide", "Amlodipine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/029/001", "product_name": "Midon 5 mg tablets", "holder": "Originalis B.V.", "authorised_date": "2023-12-08", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/030/001", "product_name": "Zovirax 800 mg Dispersible Tablets", "holder": "Originalis B.V.", "authorised_date": "2024-01-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/031/001", "product_name": "Zarontin 250mg/5ml Syrup", "holder": "Originalis B.V.", "authorised_date": "2024-01-05", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "N03AD01" ], "active_substances": [ "Ethosuximide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/032/001", "product_name": "Midon 2.5 mg Tablets", "holder": "Originalis B.V.", "authorised_date": "2024-03-15", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA", "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Not Currently Available" }, { "licence_number": "PPA2306/034/001", "product_name": "Crestor 20 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2024-09-06", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA07" ], "active_substances": [ "Rosuvastatin calcium" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/035/001", "product_name": "Dostinex 500 microgram tablets", "holder": "Originalis B.V.", "authorised_date": "2024-07-26", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "G02CB", "G02CB03" ], "active_substances": [ "Cabergoline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/036/001", "product_name": "ELIGARD 22.5 mg powder and solvent for solution for injection", "holder": "Originalis B.V.", "authorised_date": "2024-10-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/037/001", "product_name": "ELIGARD 45 mg powder and solvent for solution for injection", "holder": "Originalis B.V.", "authorised_date": "2025-05-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for solution for injection", "atc_codes": [ "L02AE02" ], "active_substances": [ "Leuprorelin acetate" ], "routes": [ "Subcutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/038/001", "product_name": "Crestor 5 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2025-01-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/038/002", "product_name": "Crestor 10 mg film-coated tablets", "holder": "Originalis B.V.", "authorised_date": "2025-01-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "C10AA07" ], "active_substances": [ "Rosuvastatin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/040/001", "product_name": "Cariban 10 mg/10 mg modified-release hard capsules", "holder": "Originalis B.V.", "authorised_date": "2025-09-19", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release capsule, hard", "atc_codes": [ "R06AA59" ], "active_substances": [ "DOXYLAMINE SUCCINATE", "Pyridoxine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA2306/041/001", "product_name": "Citidaron 1.5 mg tablets", "holder": "Originalis B.V.", "authorised_date": "2026-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N07BA" ], "active_substances": [ "Cytisinicline" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/001/001", "product_name": "Nasonex 50 micrograms/actuation Nasal Spray, Suspension", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2018-02-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD09" ], "active_substances": [ "Mometasone furoate" ], "routes": [ "Nasal use", "Not Currently Available" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/003/001", "product_name": "Nexium 20 mg gastro-resistant tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2010-05-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/003/002", "product_name": "Nexium 40 mg gastro-resistant tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2010-05-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [ "A02BC05" ], "active_substances": [ "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/007/001", "product_name": "Spiriva 18 microgram inhalation powder, hard capsule", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2012-08-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, hard capsule", "atc_codes": [ "R03BB", "R03BB04" ], "active_substances": [ "Tiotropium bromide" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/008/001", "product_name": "Dalacin C 150 mg Hard Capsules", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2013-06-28", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "J01FF01" ], "active_substances": [ "Clindamycin" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/013/001", "product_name": "Versatis 700 mg medicated plaster", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Medicated plaster", "atc_codes": [ "N01BB02" ], "active_substances": [ "Lidocaine" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/014/001", "product_name": "Lamictal 25 mg tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX", "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/014/002", "product_name": "Lamictal 100 mg Tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2014-11-03", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "N03AX09" ], "active_substances": [ "Lamotrigine" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/015/001", "product_name": "Triapin 5 mg/5 mg prolonged release tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2016-03-11", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Prolonged-release tablet", "atc_codes": [ "C09BB", "C09BB05" ], "active_substances": [ "Felodipine", "Ramipril" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/016/001", "product_name": "Topamax 25 mg film-coated tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2006-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/016/002", "product_name": "Topamax 50 mg film-coated tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2006-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/016/003", "product_name": "Topamax 100 mg film-coated tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2006-09-22", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N03AX11" ], "active_substances": [ "Topiramate" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/018/001", "product_name": "Dymista 137 micrograms/50 micrograms per actuation, Nasal Spray Suspension", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2018-02-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Nasal spray, suspension", "atc_codes": [ "R01AD", "R01AD58" ], "active_substances": [ "Fluticasone propionate", "Azelastine hydrochloride" ], "routes": [ "Nasal use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/021/001", "product_name": "Symbicort Turbohaler 200 micrograms/6 micrograms/inhalation, inhalation powder", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2020-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK07" ], "active_substances": [ "Budesonide", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/021/002", "product_name": "Symbicort Turbohaler 400 micrograms/12 micrograms/inhalation, inhalation powder", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2020-08-25", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder", "atc_codes": [ "R03AK07" ], "active_substances": [ "Budesonide dihydrate", "Formoterol fumarate dihydrate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/024/001", "product_name": "Midon 2.5 mg tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA", "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/024/002", "product_name": "Midon 5 mg tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2022-09-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [ "C01CA", "C01CA17" ], "active_substances": [ "Midodrine hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/025/001", "product_name": "Combodart 0.5 mg/ 0.4 mg hard capsules", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2023-06-09", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04CA", "G04CA52" ], "active_substances": [ "Dutasteride", "Tamsulosin hydrochloride" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/026/001", "product_name": "Divigel 0.1% w/w Gel, 1 mg/dose", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2023-04-21", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [ "G03CA", "G03CA03" ], "active_substances": [ "Estradiol" ], "routes": [ "Transdermal use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/028/001", "product_name": "Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2023-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/028/002", "product_name": "Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder, pre-dispensed", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2023-06-02", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Inhalation powder, pre-dispensed", "atc_codes": [ "R03AK06" ], "active_substances": [ "Salmeterol", "Fluticasone propionate" ], "routes": [ "Inhalation use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/029/001", "product_name": "Zovirax 800 mg Dispersible Tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2023-06-23", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Dispersible tablet", "atc_codes": [ "J05AB", "J05AB01" ], "active_substances": [ "Aciclovir" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/031/001", "product_name": "VIMOVO 500 mg/20 mg modified-release tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2023-07-17", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Modified-release tablet", "atc_codes": [ "M01AE52" ], "active_substances": [ "Naproxen", "Esomeprazole" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product subject to prescription which may be renewed (B)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/032/001", "product_name": "Testogel 50 mg transdermal gel in sachet", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2024-05-31", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Transdermal gel in sachet", "atc_codes": [ "G03BA03" ], "active_substances": [ "Testosterone" ], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA23080/033/001", "product_name": "Vesomni 6 mg/0.4 mg modified-release tablets", "holder": "Merit Pharmaceuticals Limited", "authorised_date": "2024-04-12", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", 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76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA25370/003/001", "product_name": "Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection", "holder": "BModesto B.V.", "authorised_date": "2025-07-04", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Powder and solvent for prolonged-release suspension for injection", "atc_codes": [ "L02AE04" ], "active_substances": [ "Triptorelin pamoate" ], "routes": [ "Intramuscular use" ], "dispensing_status": [ "Product subject to prescription which may not be renewed (A)" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC" }, { "licence_number": "PPA25370/004/001", "product_name": "ELIGARD 22.5 mg powder and solvent for solution for injection", "holder": "BModesto B.V.", "authorised_date": "2025-06-27", "product_type": "HM", "market_status": "Unknown", 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"Medithyme Cough Syrup", "holder": "Clonmel Healthcare Ltd", "authorised_date": "2021-01-15", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR0979/087/001", "product_name": "Strepsils Herbal Chesty Cough syrup", "holder": "Reckitt Benckiser Ireland Limited", "authorised_date": "2026-03-06", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA12" ], "active_substances": [ "Ivy leaf dry extract (der 4-8:1)" ], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical 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"2026-02-27", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pastille", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR1242/001/001", "product_name": "Ginkgo-Biloba Pharma Nord film-coated tablets", "holder": "Pharma Nord ApS", "authorised_date": "2018-03-16", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Traditional use registration for herbal medicinal 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"dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR1725/001/001", "product_name": "Echinace Tablets", "holder": "Sona Nutrition Ltd", "authorised_date": "2014-07-04", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2006/001/001", "product_name": "Buttercup Bronchostop Cough Syrup", "holder": "Kwizda Pharma GmbH", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA", "R05CA10" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2006/001/002", "product_name": "Buttercup Bronchostop Berry Flavour Cough Pastilles", "holder": "Kwizda Pharma GmbH", "authorised_date": "2015-03-13", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Pastille", "atc_codes": [ "R05CA", "R05CA10" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and 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"AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CM" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR22702/002/001", "product_name": "Kalms Day film-coated tablets", "holder": "LanesHealth (Ireland) Limited", "authorised_date": "2013-05-10", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [ "N05CM" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR22953/001/001", "product_name": "Ellura hard capsules", "holder": "Laboratoire Pharmaceutique Pharmatoka SAS", "authorised_date": "2023-10-20", "product_type": "HM", "market_status": "Unknown", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [ "G04BX" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/001/001", "product_name": "Atrogel Arnica Gel", "holder": "A.Vogel Ireland Limited", "authorised_date": "2011-01-14", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gel", "atc_codes": [], "active_substances": [], "routes": [ "Cutaneous use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/002/001", "product_name": "Prostasan soft capsules", "holder": "A.Vogel Ireland Limited", "authorised_date": "2012-05-25", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Capsule, soft", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/003/001", "product_name": "Atrosan Devil's Claw film-coated tablets", "holder": "A.Vogel Ireland Limited", "authorised_date": "2011-12-09", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Film-coated tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/004/001", "product_name": "Menoforce Sage tablets", "holder": "A.Vogel Ireland Limited", "authorised_date": "2013-05-03", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/005/001", "product_name": "Dormeasan Sleep Valerian-Hops oral drops", "holder": "A.Vogel Ireland Limited", "authorised_date": "2014-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/008/001", "product_name": "Bronchosan dry, tickly cough syrup", "holder": "A.Vogel Ireland Limited", "authorised_date": "2014-03-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/009/001", "product_name": "Echinaforce Forte Cold and Flu tablets", "holder": "A.Vogel Ireland Limited", "authorised_date": "2012-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/009/002", "product_name": "Echinaforce Cold and Flu Oral Drops", "holder": "A.Vogel Ireland Limited", "authorised_date": "2013-07-19", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [ "L03A" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/009/004", "product_name": "Echinaforce Cold & Flu tablets", "holder": "A.Vogel Ireland Limited", "authorised_date": "2012-11-05", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/009/005", "product_name": "Echinaforce Hot Drink Cold and Flu Echinacea concentrate for oral solution", "holder": "A.Vogel Ireland Limited", "authorised_date": "2016-10-07", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Concentrate for oral solution", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/010/001", "product_name": "Bronchoforce chesty cough oral drops", "holder": "A.Vogel Ireland Limited", "authorised_date": "2015-02-27", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/011/001", "product_name": "Venaforce Varicose Veins gastro-resistant tablets", "holder": "A.Vogel Ireland Limited", "authorised_date": "2011-12-16", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Gastro-resistant tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/013/001", "product_name": "Echinaforce Sore Throat Spray", "holder": "A.Vogel Ireland Limited", "authorised_date": "2015-04-24", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oromucosal spray, solution", "atc_codes": [ "R02A" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/015/001", "product_name": "Artichoke-Milk Thistle Complex Tablets", "holder": "A.Vogel Ireland Limited", "authorised_date": "2014-07-25", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Tablet", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/017/001", "product_name": "Agnus castus oral drops", "holder": "A.Vogel Ireland Limited", "authorised_date": "2014-12-12", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/020/001", "product_name": "Valerian Complex Stress Relief Oral Drops", "holder": "A.Vogel Ireland Limited", "authorised_date": "2014-05-02", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR2309/021/001", "product_name": "A.Vogel Uva-ursi & Echinacea Cystitis oral drops", "holder": "A.Vogel Ireland Limited", "authorised_date": "2020-06-26", "product_type": "HM", "market_status": "Marketed", "registration_status": "AU", "dosage_form": "Oral drops, solution", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through pharmacies only", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR23490/001/001", "product_name": "Benylin Herbal Chesty Coughs Syrup", "holder": "JNTL Consumer Health I (Ireland) Limited", "authorised_date": "2024-11-15", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Syrup", "atc_codes": [ "R05CA12" ], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" }, { "licence_number": "TR25313/001/001", "product_name": "Valdrian hard capsules", "holder": "HUK Europe Limited", "authorised_date": "2011-09-23", "product_type": "HM", "market_status": "Not marketed", "registration_status": "AU", "dosage_form": "Capsule, hard", "atc_codes": [], "active_substances": [], "routes": [ "Oral use" ], "dispensing_status": [ "Product not subject to medical prescription" ], "supply_status": "Supply through non-pharmacy outlets and pharmacies", "legal_basis": "Traditional use registration for herbal medicinal product application (Article 16a of Directive No 2001/83/EC)" } ] }