| Fostair 200 microgram/6 microgram per actuation pressurised inhalation solution PA0584/008/003 |
Beclometasone dipropionate, Formoterol fumarate dihydrate |
Chiesi Farmaceutici S.p.A. |
Not marketed |
| Fostair Nexthaler 100 micrograms/6 micrograms per metered dose inhalation powder PA0584/008/002 |
Beclometasone dipropionate, Formoterol fumarate dihydrate |
Chiesi Farmaceutici S.p.A. |
Not marketed |
| Fostair Nexthaler 200 micrograms/6 micrograms per metered dose inhalation powder PA0584/008/004 |
Formoterol fumarate dihydrate, Beclometasone dipropionate anhydrous |
Chiesi Farmaceutici S.p.A. |
Not marketed |
| Fusidic acid/Betamethasone Bailleul 20 mg/g + 1 mg/g Cream PA25477/001/001 |
Fusidic acid, Betamethasone valerate |
Laboratoires Bailleul S.A. |
Not marketed |
| Fycompa 0.5 mg film-coated tablets EU/1/12/776/024 |
Perampanel |
Eisai GmbH |
— |
| Fycompa 10 mg film-coated tablets EU/1/12/776/011-013 |
Perampanel |
Eisai GmbH |
— |
| Fycompa 12 mg film-coated tablets EU/1/12/776/014-016 |
Perampanel |
Eisai GmbH |
— |
| Fycompa 2 mg film-coated tablets EU/1/12/776/001 |
Perampanel |
Eisai GmbH |
— |
| Fycompa 4 mg film-coated tablets EU/1/12/776/002-004 |
Perampanel |
Eisai GmbH |
— |
| Fycompa 6 mg film-coated tablets EU/1/12/776/005-007 |
Perampanel |
Eisai GmbH |
— |
| Fycompa 8 mg film-coated tablets EU/1/12/776/008-010 |
Perampanel |
Eisai GmbH |
— |
| Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection PA1107/012/001 |
Tropicamide, Phenylephrine hydrochloride, Lidocaine Hydrochloride Monohydrate |
Laboratoires Thea |
Marketed |
| Gaviscon Liquid-Aniseed Flavour, Oral Suspension Each 10 ml contains: Sodium alginate 500 mg Sodium bicarbonate 267 mg Calcium carbonate 160 mg PA0979/015/003 |
Sodium bicarbonate, Calcium carbonate, Sodium alginate |
Reckitt Benckiser Ireland Ltd |
Marketed |
| Giapreza 2.5 mg/ml Concentrate for solution for infusion EU/1/19/1384/001-002 |
|
Paion Pharma GmbH |
— |
| GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe PA22641/002/002 |
Lenograstim |
Chugai Pharma France |
Marketed |
| GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion, in a pre-filled syringe PA22641/002/001 |
Lenograstim |
Chugai Pharma France |
Marketed |
| HALAVEN 0.44 mg/ml solution for injection EU/1/11/678/001-002 |
Eribulin mesylate |
Eisai GmbH |
— |
| Helicobacter Test INFAI 75 mg powder for oral solution EU/1/97/045/001 |
13c-urea |
INFAI Institut fur biomedizinish |
— |
| Helicobacter Test INFAI for children of the age 3-11 EU/1/97/045/003 |
13c-urea |
INFAI Institut fur biomedizinish |
— |
| Heparin Sodium 10 IU/ml flushing solution for maintenance of patency of intravenous devices PA0281/230/001 |
Heparin sodium |
Pinewood Laboratories Ltd |
Marketed |
| 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. |
— |
| 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 |
| Incellipan suspension for injection in pre-filled syringe Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures). EU/1/24/1807/001 |
Influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen |
Seqirus Netherlands B.V. |
— |
| Influvac sub-unit, suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated) PA23355/031/001 |
A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238, Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26), Influenza A virus, A/Croatia/10136RV/2023 (H3N2) like strain X-425A, Inactivated |
Viatris Healthcare Limited |
Marketed |
| Influvac Tetra, suspension for injection in pre-filled syringe (influenza vaccine, surface antigen, inactivated) PA23355/016/001 |
A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215), B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type), Influenza A virus, A/Croatia/10136RV/2023 (H3N2) like strain X-425A, Inactivated |
Viatris Healthcare Limited |
Not marketed |
| Inhixa 30,000 IU (300 mg)/3 mL solution for injection in multidose container EU/1/16/1132/071 |
Enoxaparin sodium, Enoxaparin sodium |
Techdow Pharma Netherlands B.V |
— |
| Inhixa 50,000 IU (500 mg)/5 mL solution for injection in multidose container EU/1/16/1132/072 |
Enoxaparin sodium, Enoxaparin sodium |
Techdow Pharma Netherlands B.V |
— |
| Inovelon EU/1/06/378/1-16 |
Rufinamide |
Eisai GmbH |
— |
| Inovelon 40 mg/ml oral suspension EU/1/06/378/017 |
Rufinamide |
Eisai GmbH |
— |
| Instillagel 6 ml Urethral, vaginal, rectal and oropharyngeal gel PA0328/001/001 |
Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur., Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Lidocaine hydrochloride |
Farco-Pharma GmbH |
Marketed |
| Instillagel® 11 ml Urethral, vaginal, rectal and oropharyngeal gel PA0328/001/002 |
Chlorhexidine digluconate (as chlorhexidine digluconate solution (20% w/v) ph.eur., Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Lidocaine hydrochloride |
Farco-Pharma GmbH |
Marketed |
| IXCHIQ powder and solvent for solution for injection Chikungunya vaccine (live) EU/1/24/1828/001 |
Chikungunya virus, strain CHIKV LR2006-OPY1, live attenuated |
Valneva Austria GmbH |
— |
| Ketofall 0.25 mg/ml eye drops, solution in single-dose container PA1815/002/001 |
Ketotifen hydrogen fumarate |
Pharma Stulln GmbH |
Marketed |
| Kisplyx 10 mg hard capsules EU/1/16/1128/002 |
Lenvatinib mesilate |
Eisai GmbH |
— |
| Kisplyx 4 mg hard capsules EU/1/16/1128/001 |
Lenvatinib mesilate |
Eisai GmbH |
— |
| Kostaive powder for dispersion for injection. COVID-19 sa-mRNA Vaccine EU/1/24/1873/001 |
Zapomeran |
Arcturus Therapeutics Europe B.V. |
— |
| Kymriah 1.2 × 106 – 6 × 108 cells dispersion for infusion EU/1/18/1297/001 |
AUTOGLAS T CELLS TRANSDUCED WITH LENTIVIRAL VECTOR CONTAINING A CHIMERIC ANTIGEN RECEPTOR DIRECTED AGAINST CD1 |
Novartis Europharm Limited |
— |
| LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed EU/1/14/899/001-003 |
Umeclidinium bromide, Vilanterol trifenatate |
GlaxoSmithKline Trading Services Limited |
— |
| Laxido Paediatric Plain, 6.9 g sachet, powder for oral solution PA22680/001/003 |
Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride |
Galen Pharma Ireland Limited |
Marketed |
| Lemsip Chesty Cough 50mg/5ml Oral Solution PA0979/026/001 |
Guaifenesin |
Reckitt Benckiser Ireland Ltd |
Marketed |
| Lemsip Cough and Cold Capsules with CaffeineParacetamol 500mgGuaifenesin 100mgCaffeine 25mg PA0979/029/001 |
Paracetamol, Guaifenesin, Caffeine anhydrous |
Reckitt Benckiser Ireland Ltd, |
Marketed |
| Lemsip Max Cough & Cold Powder for Oral Solution Paracetamol 1000 mg Guaifenesin 200 mg PA0979/028/001 |
Paracetamol, Guaifenesin |
Reckitt Benckiser Ireland Ltd, |
Marketed |
| Lemsip Multirelief capsules Paracetamol 500mg Phenylephrine hydrochloride 6.1mg Guaifenesin 100mg PA0979/053/001 |
Paracetamol, Phenylephrine hydrochloride, Guaifenesin |
Reckitt Benckiser Ireland Ltd, |
Marketed |
| LENVIMA 10 mg hard capsules EU/1/15/1002/002 |
Lenvatinib mesylate |
Eisai GmbH |
— |
| LENVIMA 4 mg hard capsules EU/1/15/1002/001 |
Lenvatinib mesylate |
Eisai GmbH |
— |
| LEQEMBI 100 mg/mL concentrate for solution for infusion EU/1/24/1891/001-002 |
Lecanemab |
Eisai GmbH |
— |
| Levobupivacaine 0.625 mg/ml solution for infusion PA2059/009/001 |
Levobupivacaine |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Levobupivacaine 1.25 mg/mL solution for infusion PA2059/009/002 |
Levobupivacaine |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Levobupivacaine 2.5 mg/mL solution for injection/infusion PA2059/009/003 |
Levobupivacaine |
Fresenius Kabi Deutschland GmbH |
Marketed |