| Benepali 50 mg solution for injection in pre-filled pen EU/1/15/1074/002 |
Etanercept |
Samsung Bioepis NL B.V. |
— |
| Benepali 50 mg solution for injection in pre-filled syringe EU/1/15/1074/001 |
Etanercept |
Samsung Bioepis NL B.V. |
— |
| Benlysta 120 mg powder for concentrate for solution for infusion EU/1/11/700/001-002 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benlysta 200 mg solution for injection in pre-filled pen EU/1/11/700/003-005 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benlysta 200 mg solution for injection in pre-filled syringe EU/1/11/700/006-007 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| BENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets PA23490/006/001 |
Paracetamol, PSEUDOEPHEDRINE HYDROCHLORIDE, Paracetamol, Diphenhydramine hydrochloride |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Dual Action Dry Syrup, Pseudoephedrine 30mg, Dextromethorphan 10mg, Triprolidine 1.25mg PA23490/002/001 |
Dextromethorphan hydrobromide, PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg PA23490/013/001 |
Paracetamol, PSEUDOEPHEDRINE HYDROCHLORIDE, Diphenhydramine hydrochloride |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 ml PA23490/015/001 |
PSEUDOEPHEDRINE HYDROCHLORIDE, Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion PA2059/085/002 |
Benzylpenicillin Sodium |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Benzylpenicillin sodium 600 mg powder for solution for injection/infusion PA2059/085/001 |
Benzylpenicillin Sodium |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Beovu 120 mg/ml solution for injection in pre-filled syringe EU/1/19/1417/001-002 |
Brolucizumab |
Novartis Europharm Limited |
— |
| Beromun 1 mg powder for solution for infusion EU/1/99/097/001 |
Tumour necrosis factor alfa 1a |
Belpharma S.A. |
— |
| BESPONSA 1 mg powder for concentrate for solution for infusion EU/1/17/1200/001 |
Inotuzumab ozogamicin |
Pfizer Europe MA EEIG |
— |
| Besremi 250 micogram/0.5 ml Solution for injection in pre-filled pen EU/1/18/1352/001 |
Ropeginterferon alfa-2b |
Aop Orphan Pharmaceuticals GmbH |
— |
| Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen EU/1/18/1352/002 |
Ropeginterferon alfa-2b |
Aop Orphan Pharmaceuticals GmbH |
— |
| Betaferon 250 microgram/ml, powder and solvent for solution for injection EU/1/95/003/005-012 |
Interferon beta-1b |
Schering AG |
— |
| Betahistine dihydrochloride 16 mg Tablets PA22871/017/002 |
Betahistine dihydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Betahistine dihydrochloride 24 mg Tablets PA22871/017/003 |
Betahistine dihydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Betahistine dihydrochloride 8 mg Tablets PA22871/017/001 |
Betahistine dihydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Betmiga 25 mg prolonged-release tablets EU/1/12/809/001-007 |
Mirabegron (ym178) |
Astellas Pharma Europe BV |
— |
| Betmiga 50 mg prolonged-release tablets EU/1/12/809/008-014 |
Mirabegron (ym178) |
Astellas Pharma Europe BV |
— |
| Betmiga 8 mg/ml Granules for prolonged-release oral suspension EU/1/12/809/019-020 |
Mirabegron |
Astellas Pharma Europe B.V. |
— |
| Betnesol 0.1% w/v Eye, Ear and Nasal Drops, solution PA1638/001/001 |
BETAMETHASONE SODIUM PHOSPHATE |
RPH Pharmaceuticals AB |
Marketed |
| Betnesol-N 0.1% w/v, 3500 IU/ml Eye, Ear and Nasal Drops, solution PA1638/002/001 |
Neomycin sulfate, BETAMETHASONE SODIUM PHOSPHATE |
RPH Pharmaceuticals AB |
Marketed |
| Bettamousse 1 mg/g (0.1%) cutaneous foam PA1638/009/001 |
Betamethasone valerate |
RPH Pharmaceuticals AB |
Marketed |
| Bevespi Aerosphere 7.2 micrograms/5 micrograms pressurised inhalation, suspension EU/1/18/1339/001 |
Formoterol fumarate dihydrate, GLYCOPYRRONIUM |
AstraZeneca AB |
— |
| Bexsero 0.5 ml suspension for injection in pre-filled syringe EU/1/12/812/001-004 |
Recombinant neisseria meningitidis serogroup b nhba fusion protein, Recombinant neisseria meningitidis serogroup b nada fusion protein, Recombinant neisseria meningitidis serogroup b fhbp fusion protein, Outer rmembrane vesicles (omv) |
Glaxosmithkline Vaccines S.r.l. |
— |
| Beyfortus 100 mg solution for injection in pre-filled syringe EU/1/22/1689/004-006 |
Nirsevimab |
Sanofi Winthrop Industrie |
— |
| Beyfortus 50 mg solution for injection in pre-filled syringe EU/1/22/1689/001-003 |
Nirsevimab |
Sanofi Winthrop Industrie |
— |
| BEYONTTRA 356 mg film-coated tablets EU/1/24/1906/001 |
Acoramidis hydrochloride |
Bayer AG |
— |
| Biktarvy 30 mg/120 mg/15 mg Film-coated tablet EU/1/18/1289/005-006 |
Bictegravir Sodium, Emtricitabine, Tenofovir alafenamide fumarate |
Gilead Sciences Ireland UC |
— |
| Biktarvy 50 mg/200 mg/25 mg Film-coated tablet EU/1/18/1289/001-002 |
Bictegravir, Emtricitabine, Tenofovir alafenamide |
Gilead Sciences Ireland UC |
— |
| Bildyos 60 mg solution for injection EU/1/25/1978/002 |
Denosumab |
Sciencepharma Sp. z o.o. |
— |
| Bildyos 60 mg solution for injection in pre-filled syringe EU/1/25/1978/001 |
Denosumab |
Sciencepharma Sp. z o.o. |
— |
| Bilprevda 120 mg solution for injection EU/1/25/1979/001 |
Denosumab |
Henlius Europe GmbH |
— |
| BIMERVAX emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted) EU/1/22/1709/001-004 |
SARS-CoV-2 virus, variants B.1.351-B.1.1.7, spike protein, receptor binding domain fusion heterodimer |
Hipra Human Health S.L. |
— |
| BIMERVAX XBB.1.16. COVID-19 Vaccine (recombinant, adjuvanted) EU/1/22/1709/005-007 |
SARS-CoV-2, variant XBB.1.16, spike protein, receptor binding domain fusion homodimer |
Hipra Human Health S.L. |
— |
| Bimzelx 160 mg solution for injection in pre-filled pen EU/1/21/1575/005-008 |
Bimekizumab |
UCB Pharma S.A. |
— |
| Bimzelx 160 mg solution for injection in pre-filled syringe EU/1/21/1575/001-004 |
Bimekizumab |
UCB Pharma S.A. |
— |
| Bimzelx 320 mg solution for injection in pre-filled pen EU/1/21/1575/011-012 |
Bimekizumab |
UCB Biopharma SPRL |
— |
| Bimzelx 320 mg solution for injection in pre-filled syringe EU/1/21/1575/009-010 |
Bimekizumab |
UCB Biopharma SPRL |
— |
| Binocrit 1 000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/410/1-2 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |
| Binocrit 10 000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/410/15-16 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |
| Binocrit 2 000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/410/3-4 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |
| Binocrit 20 000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/410/21-22 |
Epoetin alfa |
Sandoz GmbH |
— |
| Binocrit 3 000 IU/0.3 mL solution for injection in a pre-filled syringe EU/1/07/410/5-6 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |
| Binocrit 30 000 IU/0.75 mL solution for injection in a pre-filled syringe EU/1/07/410/23-24 |
Epoetin alfa |
Sandoz GmbH |
— |
| Binocrit 4 000 IU/0.4 mL solution for injection in a pre-filled syringe EU/1/07/410/7-8 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |
| Binocrit 40 000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/410/25-26 |
Epoetin alfa |
Sandoz GmbH |
— |