| Prostin E2 2 mg Vaginal Gel PA0822/178/002 |
Dinoprostone |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Protium 20 mg gastro-resistant tablets PA2229/010/001 |
Pantoprazole sodium sesquihydrate |
Takeda Products Ireland Ltd |
Marketed |
| Protium 40 mg gastro-resistant tablets PA2229/010/002 |
Pantoprazole |
Takeda Products Ireland Ltd |
Marketed |
| Protium i.v. 40 mg Powder for Solution for Injection PA2229/010/003 |
Pantoprazole |
Takeda Products Ireland Ltd |
Marketed |
| Protizole 20 mg gastro-resistant tablet PA2315/260/001 |
Pantoprazole sodium sesquihydrate |
Accord Healthcare Ireland Ltd. |
Marketed |
| Protizole 40 mg gastro-resistant tablet PA2315/260/002 |
Pantoprazole sodium sesquihydrate |
Accord Healthcare Ireland Ltd. |
Marketed |
| Provera 10 mg tablets PA0822/134/003 |
Medroxyprogesterone acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| PULMOTEC Kit for radiopharmaceutical preparation PA1034/001/001 |
Graphites |
Cyclomedica Ireland Ltd |
Marketed |
| Pulmozyme 2500 U/ 2.5ml, nebuliser solution PA2307/005/001 |
Dornase alfa |
Roche Products (Ireland) Limited |
Marketed |
| Pyranistole 200 mg prolonged release capsules PA22865/001/001 |
Dipyridamole |
Renata Pharmaceuticals (Ireland) Limited |
Marketed |
| Qdenga powder and solvent for solution for injection EU/1/22/1699/001 |
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Qdenga powder and solvent for solution for injection EU/1/22/1699/002 |
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Qdenga powder and solvent for solution for injection EU/1/22/1699/003 |
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Qdenga powder and solvent for solution for injection EU/1/22/1699/004 |
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Quetiapine 100 mg film-coated tablets PA2315/117/002 |
Quetiapine |
Accord Healthcare Ireland Ltd. |
Marketed |
| Quetiapine 200 mg film-coated tablets PA2315/117/003 |
Quetiapine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Quetiapine 25 mg film-coated tablets PA2315/117/001 |
Quetiapine |
Accord Healthcare Ireland Ltd. |
Marketed |
| Quetiapine 300 mg film-coated tablets PA2315/117/004 |
Quetiapine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Ranolazine Accord 375 mg prolonged-release tablets PA2315/259/001 |
Ranolazine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Ranolazine Accord 500 mg prolonged-release tablet PA2315/259/002 |
Ranolazine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Ranolazine Accord 750 mg prolonged-release tablets PA2315/259/003 |
Ranolazine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Raporsin 4 mg prolonged-release tablets PA2315/005/002 |
Doxazosin mesilate |
Accord Healthcare Ireland Ltd. |
Marketed |
| Raporsin 8 mg prolonged-release tablets PA2315/005/001 |
Doxazosin |
Accord Healthcare Ireland Ltd. |
Marketed |
| Rasagiline Accord 1 mg tablets PA2315/174/001 |
Rasagiline |
Accord Healthcare Ireland Ltd. |
Marketed |
| Rasilez 150 mg film-coated tablets EU/1/07/405/021-030 |
Aliskiren hemifumarate |
Lxo Ireland Designated Activity Company |
— |
| Regaine Extra Strength 5% w/v Cutaneous Solution PA23490/038/002 |
Minoxidil |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam PA23490/018/001 |
Minoxidil |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Regaine for Women Extra Strength Scalp Foam 5% w/w Cutaneous Foam PA23490/018/002 |
Minoxidil |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Regaine for Women Regular Strength 2% w/v Cutaneous Solution PA23490/038/001 |
Minoxidil |
JNTL Consumer Health (Ireland) Limited |
Not marketed |
| Relenza 5mg/dose, inhalation powder, pre-dispensed PA1077/011/001 |
Zanamivir |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Relistor EU/1/08/463/004-008 |
Methylnaltrexone bromide |
Bausch Health Ireland Limited |
— |
| Relistor EU/1/08/463/8-11 |
Methylnaltrexone bromide |
Bausch Health Ireland Limited |
— |
| RELISTOR 12 mg/0.6 mL solution for injection EU/1/08/463/1-3 |
Methylnaltrexone bromide |
Bausch Health Ireland Limited |
— |
| Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed EU/1/13/886/004-006 |
Fluticasone furoate, Vilanterol trifenatate micronised |
GlaxoSmithKline (Ireland) Limited |
— |
| Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed EU/1/13/886/001-003 |
Fluticasone furoate, Vilanterol trifenatate micronised |
GlaxoSmithKline (Ireland) Limited |
— |
| Remegel 800 mg Chewable Tablets PA0979/077/001 |
Calcium carbonate |
Reckitt Benckiser Ireland Ltd |
Not marketed |
| Replagal 1 mg/ml concentrate for solution for infusion EU/1/01/189/001 |
Agalsidase alfa |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Requip 0.25 mg film-coated tablets PA1077/037/001 |
Ropinirole |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Requip 1 mg film-coated tablets PA1077/037/003 |
Ropinirole |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Requip 2 mg film-coated tablets PA1077/037/004 |
Ropinirole |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Requip 5 mg film-coated tablets PA1077/037/005 |
Ropinirole |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Requip-Modutab 2 mg Prolonged-Release Tablets PA1077/037/006 |
Ropinirole hydrochloride |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Requip-Modutab 4 mg Prolonged-Release Tablets PA1077/037/008 |
Ropinirole hydrochloride |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Requip-Modutab 8 mg Prolonged-Release Tablets PA1077/037/009 |
Ropinirole hydrochloride |
GlaxoSmithKline (Ireland) Limited |
Not marketed |
| Resolor 1 mg film-coated tablets EU/1/09/581/001 |
Prucalopride Succinate |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Resolor 2 mg film-coated tablets EU/1/09/581/002 |
Prucalopride Succinate |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Revestive 1.25 mg powder and solvent for solution for injection EU/1/12/787/003 |
Teduglutide |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Revestive 5 mg powder and solvent for solution for injection EU/1/12/787/001 |
Teduglutide |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Revinty Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed EU/1/14/929/004-006 |
Fluticasone furoate, Vilanterol |
GlaxoSmithKline (Ireland) Limited |
— |
| Revinty Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed EU/1/14/929/001-003 |
Fluticasone furoate, Vilanterol |
GlaxoSmithKline (Ireland) Limited |
— |