| Abiraterone 500 mg film-coated tablets PA0711/304/002 |
Abiraterone acetate |
Rowex Limited, |
Not marketed |
| Abiraterone Accord 250 mg tablets EU/1/20/1512/001 |
Abiraterone acetate |
Accord Healthcare S.L.U. |
— |
| Abiraterone Accord 500 mg film-coated tablets EU/1/20/1512/002-003 |
Abiraterone acetate |
Accord Healthcare S.L.U. |
— |
| Abiraterone Aristo 250 mg tablets PA1983/008/001 |
Abiraterone acetate |
Aristo Pharma GmbH |
Not marketed |
| Abiraterone Aristo 500 mg film-coated tablets PA1983/008/002 |
Abiraterone acetate |
Aristo Pharma GmbH |
Marketed |
| Abiraterone AshCure 250 mg film-coated tablets PA25251/001/001 |
Abiraterone acetate |
AshCure Pharma B.V. |
Not marketed |
| Abiraterone AshCure 500 mg film-coated tablets PA25251/001/002 |
Abiraterone acetate |
AshCure Pharma B.V. |
Not marketed |
| Abiraterone Clonmel 500 mg film-coated tablets PA0126/336/001 |
Abiraterone acetate |
Clonmel Healthcare Ltd |
Marketed |
| Abiraterone Krka 500 mg film-coated tablets EU/1/21/1553/001-003 |
Abiraterone acetate |
KRKA, d.d., Novo mesto |
— |
| 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 |
| Abiraterone Teva 500 mg film-coated tablets PA1986/103/001 |
Abiraterone acetate |
Teva B.V. |
Marketed |
| Activelle 1 mg/0.5 mg film-coated tablets PA0218/052/001 |
Estradiol, Norethisterone acetate |
Novo Nordisk A/S |
Marketed |
| 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 |
— |
| Aminoven 16 solution for infusion, bottle PA2059/025/002 |
Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Aminoven 25 solution for infusion, bottle PA2059/025/003 |
Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Aminoven 8 solution for infusion, bottle PA2059/025/001 |
Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Androcur 100 mg tablets PA23450/004/001 |
Cyproterone acetate |
Advanz Pharma Limited |
Marketed |
| Anusol HC Ointment PA22647/002/001 |
HYDROCORTISONE ACETATE, Benzyl benzoate, Bismuth subgallate, Bismuth oxide, Balsam peru |
SOFIBEL |
Marketed |
| Anusol HC Suppositories PA22647/002/002 |
HYDROCORTISONE ACETATE, Benzyl benzoate, Bismuth oxide, Balsam peru, Zinc oxide |
SOFIBEL |
Marketed |
| ASPAVELI 1 080 mg solution for infusion EU/1/21/1595/001-002 |
Pegcetacoplan |
Apellis Ireland Limited |
— |
| Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules EU/1/20/1439/005-008 |
Indacaterol acetate, Mometasone furoate |
Novartis Europharm Limited |
— |
| Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules EU/1/20/1439/009-012 |
Indacaterol acetate, Mometasone furoate |
Novartis Europharm Limited |
— |
| Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules EU/1/20/1439/001-004 |
Indacaterol acetate, Mometasone furoate |
Novartis Europharm Limited |
— |
| Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules EU/1/20/1441/005-008 |
Indacaterol acetate, Indacaterol, Mometasone furoate |
Novartis Europharm Limited |
— |
| Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules EU/1/20/1441/009-012 |
Indacaterol acetate, Indacaterol, Mometasone furoate |
Novartis Europharm Limited |
— |
| Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules EU/1/20/1441/001-004 |
Indacaterol acetate, Indacaterol, Mometasone furoate |
Novartis Europharm 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 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 |
| Bonjela Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010% PA0979/001/001 |
Choline salicylate, Cetalkonium chloride |
Reckitt Benckiser Ireland Limited |
Marketed |
| Bonjela Teething Gel Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010% PA0979/001/003 |
Choline salicylate, Cetalkonium chloride |
Reckitt Benckiser Ireland Limited |
Marketed |
| Brabio 20 mg/ml solution for injection, pre-filled syringe PA23266/010/001 |
Glatiramer acetate |
Viatris Limited |
Marketed |
| Brabio 40 mg/ml solution for injection in pre-filled syringe PA23266/011/001 |
Glatiramer acetate |
Viatris Limited |
Marketed |
| Brivaracetam Clonmel 10 mg film-coated tablets PA0126/403/001 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 100 mg film-coated tablets PA0126/403/005 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 25 mg film-coated tablets PA0126/403/002 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 50 mg film-coated tablets PA0126/403/003 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 75 mg film-coated tablets PA0126/403/004 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Briviact 10 mg film-coated tablets EU/1/15/1073/001-004 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 10 mg/ml oral solution EU/1/15/1073/021 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 10 mg/ml solution for injection/infusion EU/1/15/1073/022 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 100 mg film-coated tablets EU/1/15/1073/017-020 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 25 mg film-coated tablets EU/1/15/1073/005-008 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 50 mg film-coated tablets EU/1/15/1073/009-012 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 75 mg film-coated tablets EU/1/15/1073/013-016 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Calcium Acetate 500mg Tablets PA0281/063/001 |
Calcium acetate |
Pinewood Laboratories Ltd |
Not marketed |
| Calpol 120 mg/ 5 ml Sugar Free Infant Oral Suspension PA23490/003/004 |
Paracetamol |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Calpol 120 mg/5 ml Infant Oral Suspension PA23490/003/001 |
Paracetamol |
JNTL Consumer Health I (Ireland) Limited |
Marketed |