| Betacap Scalp Application 0.1 % w/w cutaneous solution PA23128/010/001 |
Betamethasone valerate |
Dermal Laboratories (Ireland) Limited |
Marketed |
| Betaferon 250 microgram/ml, powder and solvent for solution for injection EU/1/95/003/005-012 |
Interferon beta-1b |
Schering AG |
— |
| Betagan 0.5% w/v Unit Dose Eye Drops, Solution PA1824/012/001 |
Levobunolol hydrochloride |
AbbVie Limited |
Not marketed |
| Betahistine dihydrochloride 16 mg Tablets PA22871/017/002 |
Betahistine dihydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Betahistine dihydrochloride 16mg tablets PA2315/078/002 |
Betahistine dihydrochloride |
Accord Healthcare Ireland 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 |
| Betahistine dihydrochloride 8mg tablets PA2315/078/001 |
Betahistine dihydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| Betaloc 1 mg/ml solution for injection PA1404/007/001 |
METOPROLOL TARTRATE |
Recordati Ireland Limited |
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 |
| Betnovate Cream 0.1% w/w PA1077/001/001 |
Betamethasone |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Betnovate Ointment 0.1% w/w PA1077/001/002 |
Betamethasone valerate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Betnovate Scalp Application 0.1% w/w Cutaneous Solution PA1077/001/003 |
Betamethasone |
GlaxoSmithKline (Ireland) Limited |
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 |
— |
| Bicalutamide 50 mg film-coated tablets PA2315/079/001 |
Bicalutamide |
Accord Healthcare Ireland Ltd. |
Marketed |
| Bicalutamide Fair-Med 150mg Film-coated Tablets PA1789/001/002 |
Bicalutamide |
Fairmed Healthcare GmbH |
Not marketed |
| Bicalutamide Fair-Med 50 mg film-coated tablets PA1789/001/001 |
Bicalutamide |
Fairmed Healthcare GmbH |
Not marketed |
| Bicalutamide Teva 50 mg film-coated tablets PA0749/032/001 |
Bicalutamide |
Teva Pharma B.V. |
Marketed |
| 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. |
— |
| Bilhista 20 mg tablets PA1178/021/001 |
Bilastine |
Alfred E Tiefenbacher (GmbH & Co. KG) |
Not marketed |
| Bilprevda 120 mg solution for injection EU/1/25/1979/001 |
Denosumab |
Henlius Europe GmbH |
— |
| Biluta 50 mg film-coated tablets PA0711/100/001 |
Bicalutamide |
Rowex Ltd |
Marketed |
| 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 |
— |
| Binocrit 5 000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/410/9-10 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |
| Binocrit 6 000 IU/0.6 mL solution for injection in a pre-filled syringe EU/1/07/410/11-12 |
Recombinant human erythropoietin alfa |
Sandoz GmbH |
— |