| AirFluSal Forspiro 50 microgram/500 microgram/dose, inhalation powder, predispensed PA0711/237/002 |
Salmeterol, Fluticasone propionate |
Rowex Ltd |
Marketed |
| AirFluSal MDI 25 microgram/125 microgram/dose pressurised inhalation, suspension PA0711/270/001 |
SALMETEROL XINAFOATE, Fluticasone propionate |
Rowex Limited, |
Not marketed |
| AirFluSal MDI 25 microgram/250 microgram/dose pressurised inhalation, suspension PA0711/270/002 |
Salmeterol, Fluticasone propionate |
Rowex Limited, |
Not marketed |
| AJOVY 225 mg Solution for injection EU/1/19/1358/001-002 |
FREMANEZUMAB |
TEVA GmbH |
— |
| AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container EU/1/24/1840/001-003 |
Polihexanide |
SIFI S.p.A. |
— |
| Akeega 100mg/500 mg Film-coated tablet EU/1/23/1722/002 |
Niraparib Tosilate Monohydrate, Abiraterone acetate |
Janssen-Cilag International NV |
— |
| Akeega 50 mg/500 mg Film-coated tablet EU/1/23/1722/001 |
Niraparib Tosilate Monohydrate, Abiraterone acetate |
Janssen-Cilag International NV |
— |
| Akineton 2 mg tablets PA1253/001/001 |
Biperiden hydrochloride |
Laboratorio Farmaceutico S.I.T. |
Marketed |
| Akineton Retard 4 mg prolonged release tablets PA1253/002/001 |
Biperiden hydrochloride |
Laboratorio Farmaceutico S.I.T. |
Marketed |
| Aklief 50 microgram/g Cream PA22743/017/001 |
Trifarotene |
Galderma International |
Not marketed |
| Akynzeo 235 mg/0.25 mg concentrate for solution for infusion EU/1/15/1001/004 |
FOSNETUPITANT CHLORIDE HYDROCHLORIDE, Palonosetron hydrochloride |
Helsinn Birex Pharmaceuticals Limited |
— |
| Akynzeo 235 mg/0.25 mg powder for concentrate for solution for infusion EU/1/15/1001/003 |
FOSNETUPITANT CHLORIDE HYDROCHLORIDE, Palonosetron hydrochloride |
Helsinn Birex Pharmaceuticals Limited |
— |
| Akynzeo 300 mg/0.5 mg hard capsules EU/1/15/1001/001 |
Netupitant, Palonosetron (as hydrochloride) |
Helsinn Birex Pharmaceuticals Limited |
— |
| Alacare 8 mg medicated plaster PA2071/001/001 |
5-aminolevulinic acid hydrochloride |
Photonamic GmbH & Co. KG |
Not marketed |
| Albunorm 20%, 200g/l, solution for infusion PA2219/007/002 |
Human plasma protein not containing less than 96% human albumin |
Octapharma (IP) |
Marketed |
| Albunorm 5%, 50 g/l, solution for infusion PA2219/007/001 |
Human plasma protein not containing less than 96% human albumin |
Octapharma (IP) |
Marketed |
| Alburex 20, 200 g/l, solution for infusion PA0800/008/002 |
Human albumin |
CSL Behring GmbH |
Not marketed |
| Alburex 5, 50 g/l, solution for infusion PA0800/008/001 |
Human albumin |
CSL Behring GmbH |
Not marketed |
| Albutein, 200 gram(s)/litre, solution for infusion PA0849/006/002 |
Human albumin solution |
Instituto Grifols S.A. |
Not marketed |
| Albutein, 50 gram(s)/litre, solution for infusion PA0849/006/001 |
Human albumin solution |
Instituto Grifols S.A. |
Not marketed |
| Aldactone 100 mg Film-coated tablet PPA1463/223/002 |
Spironolactone |
IMED Healthcare Ltd., |
— |
| Aldactone 100 mg film-coated tablets PPA0465/418/002 |
Spironolactone |
PCO Manufacturing Ltd. |
— |
| Aldactone 100 mg Film-coated tablets PA0822/110/003 |
Spironolactone |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Aldactone 25 mg film-coated tablets PPA0465/418/001 |
Spironolactone |
PCO Manufacturing Ltd. |
— |
| Aldactone 25 mg Film-coated Tablets PA0822/110/001 |
Spironolactone |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Aldactone 25 mg Film-coated Tablets PPA1463/223/001 |
Spironolactone |
IMED Healthcare Ltd., |
— |
| Aldactone 50 mg Film-coated tablets PA0822/110/002 |
Spironolactone |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Aldara 5% w/w Cream EU/1/98/080/001 |
Imiquimod |
Viatris Healthcare Limited |
— |
| Aldurazyme 100 U/ml concentrate for solution for infusion EU/1/03/253/01-3 |
Laronidase |
Sanofi B.V. |
— |
| Alecensa 150 mg hard capsules EU/1/16/1169/001 |
Alectinib hydrochloride |
Roche Registration GmbH |
— |
| Alendronate/Colecalciferol Teva 70 mg/2800 IU tablets PA0749/196/001 |
Alendronic acid, Colecalciferol |
Teva Pharma B.V. |
Marketed |
| Alendronate/Colecalciferol Teva 70 mg/5600 IU tablets PA0749/196/002 |
Alendronic acid, Colecalciferol |
Teva Pharma B.V. |
Marketed |
| Alendronic Acid Bluefish Once weekly 70 mg tablets PA1436/004/001 |
Sodium alendronate |
Bluefish Pharmaceuticals AB |
Marketed |
| Alendronic acid/Colecalciferol Rowex 70 mg/2 800 IU tablets PA0711/319/001 |
Alendronate sodium trihydrate, Colecalciferol |
Rowex Limited, |
Not marketed |
| Alendronic acid/Colecalciferol Rowex 70 mg/5 600 IU tablets PA0711/319/002 |
Alendronate sodium trihydrate, Colecalciferol |
Rowex Limited, |
Not marketed |
| Alexette 0.02mg/3mg film-coated tablets PA1330/009/001 |
Drospirenone, Ethinylestradiol |
Gedeon Richter Plc |
Not marketed |
| Alfu 10 mg Prolonged-release Tablets PA1445/018/001 |
Alfuzosin hydrochloride |
Aurobindo Pharma (Malta) Limited |
Marketed |
| Alhemo 15 mg/1.5 mL solution for injection in pre-filled pen EU/1/24/1881/001-002 |
Concizumab |
Novo Nordisk A/S |
— |
| Alhemo 150 mg/1.5 mL solution for injection in pre-filled pen EU/1/24/1881/005-006 |
Concizumab |
Novo Nordisk A/S |
— |
| Alhemo 300 mg/3 mL solution for injection in pre-filled pen EU/1/24/1881/007 |
Concizumab |
Novo Nordisk A/S |
— |
| Alhemo 60 mg/1.5 mL solution for injection in pre-filled pen EU/1/24/1881/003-004 |
Concizumab |
Novo Nordisk A/S |
— |
| Alimta EU/1/04/290/002 |
Pemetrexed |
Eli Lilly Nederland B.V. |
— |
| Alimta 500 mg powder for concentrate for solution for infusion EU/1/04/290/001 |
Pemetrexed |
Eli Lilly Nederland B.V. |
— |
| Alka-Seltzer Effervescent Tablets Acetylsalicylic Acid (Aspirin) 324mg Sodium Hydrogen Carbonate 1744mg Citric Acid 965mg PA1410/032/001 |
Aspirin, Sodium hydrogen carbonate, Citric acid |
Bayer Limited |
Marketed |
| Alkeran 2 mg Film-coated Tablets PA1691/004/002 |
Melphalan |
Aspen Pharma Trading Limited |
Marketed |
| Alkeran 50 mg Powder and Solvent for Solution for Infusion PA1691/004/001 |
Melphalan |
Aspen Pharma Trading Limited |
Marketed |
| Alkindi 0.5 mg granules in capsules for opening EU/1/17/1260/001 |
Hydrocortisone |
Diurnal Europe B.V. |
— |
| Alkindi 1 mg granules in capsules for opening EU/1/17/1260/002 |
Hydrocortisone |
Diurnal Europe B.V. |
— |
| Alkindi 2 mg granules in capsules for opening EU/1/17/1260/003 |
Hydrocortisone |
Diurnal Europe B.V. |
— |
| Alkindi 5 mg granules in capsules for opening EU/1/17/1260/004 |
Hydrocortisone |
Diurnal Europe B.V. |
— |