| Abecma 260 - 500 x 106 cells dispersion for infusion EU/1/21/1539/001 |
Idecabtagene Vicleucel |
Bristol-Myers Squibb Pharmaceuticals uc |
— |
| Abiraterone Mylan 1000 mg film-coated tablets EU/1/21/1571/009-012 |
Abiraterone acetate |
Mylan Pharmaceuticals Limited |
— |
| Abiraterone Mylan 500 mg film-coated tablets EU/1/21/1571/001-008 |
Abiraterone acetate |
Mylan Pharmaceuticals Limited |
— |
| Abiraterone Rowa 500 mg Film-coated tablets PA0074/092/001 |
Abiraterone acetate |
Rowa Pharmaceuticals Limited, |
Marketed |
| Aclasta 5 mg solution for infusion EU/1/05/308/001 |
Zoledronic acid |
Sandoz Pharmaceuticals d.d. |
— |
| Adizem-SR 120 mg Prolonged Release Capsules PA1688/001/002 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Adizem-SR 180 mg Prolonged Release Capsules PA1688/001/003 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Adizem-SR 90 mg Prolonged Release Capsules PA1688/001/001 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| ADIZEM-XL 120mg prolonged release capsules PA1688/001/004 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| ADIZEM-XL 180mg prolonged release capsules PA1688/001/005 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| ADIZEM-XL 240 mg prolonged release capsules PA1688/001/006 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| ADIZEM-XL 300 mg prolonged release capsules PA1688/001/007 |
Diltiazem hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Adrenaline (Epinephrine) 1:1,000 Solution for Injection PA0073/035/001 |
Adrenaline (epinephrine) |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| AGAMREE 40 mg/ml oral suspension EU/1/23/1776/001 |
Vamorolone |
Santhera Pharmaceuticals (Deutschland) GmbH |
— |
| 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 |
— |
| Alendronic Acid Bluefish Once weekly 70 mg tablets PA1436/004/001 |
Sodium alendronate |
Bluefish Pharmaceuticals AB |
Marketed |
| Aloxi 250 micrograms solution for injection EU/1/04/306/001 |
Palonosetron (as hydrochloride) |
Helsinn Birex Pharmaceuticals Limited |
— |
| Aloxi 500 micrograms soft capsules EU/1/04/306/002-003 |
Palonosetron (as hydrochloride) |
Helsinn Birex Pharmaceuticals Limited |
— |
| Alyftrek 125 mg/50 mg/10 mg film-coated tablets EU/1/25/1943/002 |
Vanzacaftor, TEZACAFTOR, Deutivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Alyftrek 50 mg/20 mg/4 mg film-coated tablets EU/1/25/1943/001 |
Vanzacaftor, TEZACAFTOR, Deutivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Amantadine hydrochloride Renata 100 mg Capsules, hard PA22865/005/001 |
AMANTADINE HYDROCHLORIDE |
Renata Pharmaceuticals (Ireland) Limited |
Marketed |
| Amikacin 250 mg/ ml Solution for injection/infusion PA1418/012/001 |
AMIKACIN SULFATE |
Athlone Pharmaceuticals Limited |
Not marketed |
| Aminophylline Hydrate 25mg/ml Solution for Injection PA0073/099/001 |
Aminophylline hydrate |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Amlodipine Bluefish 10 mg tablets PA1436/016/002 |
Amlodipine besilate |
Bluefish Pharmaceuticals AB |
Marketed |
| Amlodipine Bluefish 5 mg tablets PA1436/016/001 |
Amlodipine besilate |
Bluefish Pharmaceuticals AB |
Marketed |
| Amlodipine/Valsartan Mylan 10 mg/160 mg film-coated tablets EU/1/16/1092/027-039 |
Amlodipine besilate, Valsartan |
Mylan Pharmaceuticals Limited |
— |
| Amlodipine/Valsartan Mylan 5 mg/160 mg film-coated tablets EU/1/16/1092/014-026 |
Amlodipine besilate, Valsartan |
Mylan Pharmaceuticals Limited |
— |
| Amlodipine/Valsartan Mylan 5 mg/80 mg film-coated tablets EU/1/16/1092/001-013 |
Amlodipine besilate, Valsartan |
Mylan Pharmaceuticals Limited |
— |
| Amlotan 10 mg tablet PA1418/003/002 |
Amlodipine |
Athlone Pharmaceuticals Limited |
Not marketed |
| Amlotan 5 mg tablet PA1418/003/001 |
Amlodipine |
Athlone Pharmaceuticals Limited |
Not marketed |
| Amorolfine 5% w/v medicated nail lacquer PA1436/029/001 |
Amorolfine |
Bluefish Pharmaceuticals AB |
Marketed |
| Amoxicillin Centrient 500 mg hard capsules PA1832/001/002 |
Amoxicillin (as trihydrate) |
Centrient Pharmaceuticals Netherlands B.V |
Not marketed |
| Anagrelide 0.5 mg Hard Capsules PA1418/006/001 |
Anagrelide |
Athlone Pharmaceuticals Limited |
Not marketed |
| Anagrelide Viatris 1 mg hard capsules EU/1/17/1253/002 |
Anagrelide hydrochloride monohydrate |
Mylan Pharmaceuticals Limited |
— |
| Aniva 10 mg film-coated tablets PA22871/023/001 |
Amitriptyline hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Aniva 25 mg film-coated tablets PA22871/023/002 |
Amitriptyline hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Aniva 50 mg film-coated tablets PA22871/023/003 |
Amitriptyline hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Apixaban 2.5 mg film-coated tablets PA22865/009/001 |
Apixaban |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Apixaban 5 mg film-coated tablets PA22865/009/002 |
Apixaban |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Apixaban Rowa 2.5 mg Film-coated tablets PA0074/098/001 |
Apixaban |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Apixaban Rowa 5 mg Film-coated tablets PA0074/098/002 |
Apixaban |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Arimidex 1mg Film-coated Tablets PA23154/001/001 |
Anastrozole |
Laboratoires Juvise Pharmaceuticals |
Marketed |
| Atomoxetine Azure 10 mg hard capsules PA22871/034/001 |
Atomoxetine hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Atomoxetine Azure 100 mg hard capsules PA22871/034/007 |
Atomoxetine hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Atomoxetine Azure 18 mg hard capsules PA22871/034/002 |
Atomoxetine hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Atomoxetine Azure 25 mg hard capsules PA22871/034/003 |
Atomoxetine hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Atomoxetine Azure 40 mg hard capsules PA22871/034/004 |
Atomoxetine hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Atomoxetine Azure 60 mg hard capsules PA22871/034/005 |
Atomoxetine hydrochloride |
Azure Pharmaceuticals Ltd. |
Not marketed |