| Hemosol B0 solution for haemodialysis/haemofiltration PA25288/005/001 |
Magnesium chloride hexahydrate, Calcium chloride dihydrate, Lactic acid, Sodium hydrogen carbonate, Sodium chloride |
Vantive Belgium SRL |
Marketed |
| Heparin sodium 1,000 IU/ml Solution for injection or concentrate for solution for infusion, 10ml ampoules PA0281/229/002 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| Heparin sodium 1,000 IU/ml Solution for injection or concentrate for solution for infusion, 5ml ampoules PA0281/229/001 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| Heparin sodium 1,000 IU/ml Solution for injection or concentrate for solution for infusion, 5ml vials PA0281/229/004 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| Heparin Sodium 10 IU/ml flushing solution for maintenance of patency of intravenous devices PA0281/230/001 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| Heparin sodium 25,000 IU/ml Solution for injection or concentrate for solution for infusion, 0.2ml ampoules PA0281/229/003 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| Heparin sodium 5,000 IU/ml Solution for injection or concentrate for solution for infusion, 5 ml vials PA0281/229/005 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| Heparin Sodium BP 1000 IU/l in 0.9% w/v Sodium Chloride IV Infusion PA2299/014/001 |
Heparin sodium, Sodium chloride, Disodium phosphate dodecahydrate, Citric acid monohydrate |
Baxter Holding B.V. |
Marketed |
| Heparin Sodium BP 2000 IU/l in 0.9 % w/v Sodium Chloride IV infusion PA2299/014/002 |
Citric acid monohydrate, Disodium phosphate dodecahydrate, Sodium chloride, Heparin sodium |
Baxter Holding B.V. |
Marketed |
| Hepatect CP 50 IU/ml solution for infusion PA0592/005/004 |
Human plasma protein, Hbs antibodies |
Biotest Pharma GmbH |
Marketed |
| HEPCLUDEX 2 mg powder for solution for injection EU/1/20/1446/001 |
Bulevirtide |
Gilead Sciences Ireland UC |
— |
| HEPLISAV B 20 micrograms solution for injection in pre-filled syringe EU/1/20/1503/001 |
Hepatitis b surface antigen |
Dynavax GmbH |
— |
| Herceptin 150 mg powder for concentrate for solution for infusion EU/1/00/145/001 |
Trastuzumab |
Roche Registration GmbH |
— |
| Herceptin 600 mg solution for injection in vial EU/1/00/145/002 |
Trastuzumab |
Roche Registration GmbH |
— |
| Herwenda 150 mg powder for concentrate for solution for infusion EU/1/23/1762/001 |
Trastuzumab |
Sandoz GmbH |
— |
| Herzuma 150 mg powder for concentrate for solution for infusion EU/1/17/1257/001 |
Trastuzumab |
Celltrion Healthcare Hungary Kft. |
— |
| Herzuma 420 mg powder for concentrate for solution for infusion EU/1/17/1257/002-003 |
Trastuzumab |
Celltrion Healthcare Hungary Kft. |
— |
| HETLIOZ 20 mg hard capsules EU/1/15/1008/001 |
Tasimelteon |
Vanda Pharmaceuticals Netherlands B.V. |
— |
| HETRONIFLY 10 mg/ml concentrate for solution for infusion EU/1/24/1870/001 |
Serplulimab |
Accord Healthcare S.L.U. |
— |
| Hexacima suspension for injection EU/1/13/828/001-007 |
Haemophilus influenzae type b capsular polysaccharide, Pertussis toxoid, (polyribosylribitol phosphate) conjugated to tetanous protein, Filamentous haemagglutinin, Type 1 (mahoney) |
Sanofi Winthrop Industrie |
— |
| Hexiprep 2.0% w/v/70.0% v/v Impregnated Pad PA23120/001/001 |
Chlorhexidine digluconate solution, Isopropyl alcohol |
GAMA Healthcare Ireland Ltd |
Not marketed |
| Hexvix 85 mg, powder and solvent for intravesical solution PA1024/003/001 |
Hexaminolevulinate hydrochloride |
Photocure ASA |
Not marketed |
| Hexyon suspension for injection EU/1/13/829/001-007 |
(polyribosylribitol phosphate) conjugated to tetanous protein, Type 1 (mahoney), Haemophilus influenzae type b polysaccharide, Diphtheria toxoid, Type 2 (mef-1) |
Sanofi Winthrop Industrie |
— |
| Hezkue 12.5 mg/actuation, oral suspension PA23487/002/001 |
Sildenafil citrate |
Aspargo Labs Italia S.r.l. |
Marketed |
| Hiberix. Haemophilus Type b (Hib) vaccine.Powder and Solvent for Solution for Injection PA1077/027/001 |
Haemophilus influenzae type b polysaccharide |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Hidrasec 100 mg hard capsules PA1714/001/001 |
Racecadotril |
Bioproject Europe Ltd |
Not marketed |
| Hidrasec Children 30mg Granules for Oral Suspension PA1714/001/003 |
Racecadotril |
Bioproject Europe Ltd |
Not marketed |
| Hidrasec Infants 10mg Granules for Oral Suspension PA1714/001/002 |
Racecadotril |
Bioproject Europe Ltd |
Not marketed |
| Hidrasec Infants and Children 4 mg/mL Oral Suspension PA22580/002/001 |
Racecadotril |
Bioprojet Pharma |
Not marketed |
| Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules EU/1/09/594/1-5 |
Indacaterol maleate |
Novartis Europharm Limited |
— |
| Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules EU/1/09/594/6-10 |
Indacaterol maleate |
Novartis Europharm Limited |
— |
| Hizentra 200 mg/ml solution for subcutaneous injection EU/1/11/687/001-12 |
Human normal immunoglobulin |
CSL Behring GmbH |
— |
| Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent EU/1/14/987/001 |
Ex vivo expanded autologous corneal epithelial cells containing stem cells |
Holostem S.r.l. |
— |
| Hukyndra 20 mg solution for injection in pre-filled syringe EU/1/21/1589/010 |
Adalimumab |
Stada Arzneimittel AG |
— |
| Hukyndra 40 mg solution for injection in pre-filled pen EU/1/21/1589/004-006 |
Adalimumab |
Stada Arzneimittel AG |
— |
| Hukyndra 40 mg solution for injection in pre-filled syringe EU/1/21/1589/001-003 |
Adalimumab |
Stada Arzneimittel AG |
— |
| Hukyndra 80 mg solution for injection in pre-filled pen EU/1/21/1589/008-009 |
Adalimumab |
Stada Arzneimittel AG |
— |
| Hukyndra 80 mg solution for injection in pre-filled syringe EU/1/21/1589/007 |
Adalimumab |
Stada Arzneimittel AG |
— |
| Hulio EU/1/18/1319/001-007 |
Adalimumab |
Biosimilar Collaborations Ireland Limited |
— |
| Hulio 20 mg solution for injection in pre-filled syringe EU/1/18/1319/009-010 |
Adalimumab |
Biosimilar Collaborations Ireland Limited |
— |
| Humalog EU/1/96/007/019 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Humalog 100 units/ml solution for injection in cartridge insulin lispro EU/1/96/007/004 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Humalog 100 units/ml solution for injection in vial EU/1/96/007/002 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Humalog 200 units/ml KwikPen solution for injection in a pre-filled pen EU/1/96/007/039-042 |
|
Eli Lilly and Company Limited |
— |
| Humalog Mix25 100 units/ml suspension for injection in cartridge EU/1/96/007/008 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Humalog Mix25 100 units/ml suspension for injection in vial EU/1/96/007/005 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Humalog Mix50 100 units/ml suspension for injection in cartridge EU/1/96/007/006 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Humalog NPL EU/1/96/007/010 |
Insulin lispro |
Eli Lilly Nederland B.V. |
— |
| Human Albumin Baxalta 200 g/l Solution for Infusion PA2004/004/002 |
Plasma protein containing at least 95% human albumin |
Baxalta Innovations GmbH |
Not marketed |
| Human Albumin Baxalta 50 g/l Solution for Infusion PA2004/004/001 |
Plasma protein containing at least 95% human albumin |
Baxalta Innovations GmbH |
Marketed |