| Paxneury 3 mg prolonged-release tablets EU/1/24/1908/003 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Paxneury 4 mg prolonged-release tablets EU/1/24/1908/004 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Paxneury 5 mg prolonged-release tablets EU/1/24/1908/005 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Paxneury 6 mg prolonged-release tablets EU/1/24/1908/006 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Paxneury 7 mg prolonged-release tablets EU/1/24/1908/007 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Pedippi 2 mg/ml powder for oral suspension PA1572/002/001 |
Omeprazole |
Xeolas Pharmaceuticals Limited |
Marketed |
| Pedippi 4 mg/ml powder for oral suspension PA1572/002/002 |
Omeprazole |
Xeolas Pharmaceuticals Limited |
Marketed |
| Pethidine Hydrochloride 50mg/ml Solution for Injection PA0073/014/001 |
Pethidine hydrochloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Phenylephrine Hydrochloride 10 mg/ml solution for injection/infusion PA1418/011/001 |
Phenylephrine hydrochloride |
Athlone Pharmaceuticals Limited |
Marketed |
| Plenadren 20 mg modified-release tablets EU/1/11/715/002 |
Hydrocortisone |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Plenadren 5 mg modified-release tablets EU/1/11/715/001 |
Hydrocortisone |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Ponvory 2 mg+3 mg+4 mg+5 mg+6 mg+7 mg+8 mg+9 mg+10 mg film-coated tablets EU/1/21/1550/001 |
Ponesimod |
Laboratoires Juvise Pharmaceuticals |
— |
| Ponvory 20 mg film-coated tablets EU/1/21/1550/002 |
Ponesimod |
Laboratoires Juvise Pharmaceuticals |
— |
| Potassium Chloride 15% w/v Concentrate for Solution for Infusion PA0073/106/001 |
Potassium chloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Prasugrel Viatris 10 mg EU/1/18/1273/002 |
Prasugrel |
Mylan Pharmaceuticals Limited |
— |
| Prasugrel Viatris 5 mg EU/1/18/1273/001 |
Prasugrel |
Mylan Pharmaceuticals Limited |
— |
| Prednisolone 5 mg soluble tablets PA1567/003/001 |
Prednisolone sodium phosphate |
Activase Pharmaceuticals Limited |
Not marketed |
| PRIALT EU/1/04/302/1-3 |
Ziconotide |
Esteve Pharmaceuticals GmbH |
— |
| Propranolol Azure 10 mg film-coated tablets PA22871/031/001 |
Propranolol hydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Propranolol Azure 40 mg film-coated tablets PA22871/031/002 |
Propranolol hydrochloride |
Azure Pharmaceuticals Ltd. |
Marketed |
| Provigil 100 mg tablets PA25205/001/001 |
Modafinil |
Neuraxpharm Pharmaceuticals S.L. |
Marketed |
| Provigil 200 mg tablets PA25205/001/002 |
Modafinil |
Neuraxpharm Pharmaceuticals S.L. |
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 |
— |
| QINLOCK 50 mg tablets EU/1/21/1569/001-002 |
Ripretinib |
Deciphera Pharmaceuticals (Netherlands) B.V. |
— |
| QUVIVIQ 25 mg film-coated tablets EU/1/22/1638/001-002 |
Daridorexant hydrochloride |
Idorsia Pharmaceuticals Deutschland GmbH |
— |
| QUVIVIQ 50 mg film-coated tablets EU/1/22/1638/003-004 |
Daridorexant hydrochloride |
Idorsia Pharmaceuticals Deutschland GmbH |
— |
| Razole 10 mg Gastro-resistant tablets PA0074/073/001 |
Rabeprazole sodium |
Rowa Pharmaceuticals Limited |
Not marketed |
| Razole 20 mg Gastro-resistant tablets PA0074/073/002 |
Rabeprazole sodium |
Rowa Pharmaceuticals Limited |
Not marketed |
| REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen EU/1/16/1150/004 |
Follitropin delta |
Ferring Pharmaceuticals A/S |
— |
| REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen EU/1/16/1150/005 |
Follitropin delta |
Ferring Pharmaceuticals A/S |
— |
| Rekovelle 72 micrograms/2.16 mL solution for injection in a pre-filled pen EU/1/16/1150/006 |
Follitropin delta |
Ferring Pharmaceuticals A/S |
— |
| Replagal 1 mg/ml concentrate for solution for infusion EU/1/01/189/001 |
Agalsidase alfa |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| 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 |
— |
| Rezdiffra 100 mg film-coated tablets EU/1/25/1962/003 |
Resmetirom |
Madrigal Pharmaceuticals EU Limited |
— |
| Rezdiffra 60 mg film-coated tablets EU/1/25/1962/001 |
Resmetirom |
Madrigal Pharmaceuticals EU Limited |
— |
| Rezdiffra 80 mg film-coated tablets EU/1/25/1962/002 |
Resmetirom |
Madrigal Pharmaceuticals EU Limited |
— |
| Risedronate Bluefish Once a Week 35 mg film-coated tablets PA1436/017/001 |
Risedronate sodium hemipentahydrate |
Bluefish Pharmaceuticals AB |
Marketed |
| RIULVY 174 mg gastro-resistant hard capsules EU/1/25/1947/001-002 |
Tegomil fumarate |
Neuraxpharm Pharmaceuticals S.L. |
— |
| RIULVY 348 mg gastro-resistant hard capsules EU/1/25/1947/003-005 |
Tegomil fumarate |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Rivaroxaban 10 mg film-coated tablets PA22865/010/001 |
Rivaroxaban |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Rivaroxaban 15 mg film-coated tablets PA22865/010/002 |
Rivaroxaban |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Rivaroxaban 20 mg film-coated tablets PA22865/010/003 |
Rivaroxaban |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Rivaroxaban Bluefish 10 mg film-coated tablets PA1436/044/001 |
Rivaroxaban |
Bluefish Pharmaceuticals AB |
Not marketed |