| Ibuprofen 600mg Film-coated Tablets PA23341/002/003 |
Ibuprofen |
Hualan Pharmaceuticals Limited |
Not marketed |
| IMCIVREE 10 mg/ml solution for injection EU/1/21/1564/001 |
Setmelanotide |
Rhythm Pharmaceuticals Netherlands B.V |
— |
| Inbrija 33 mg inhalation powder, hard capsules EU/1/19/1390/001-002 |
Levodopa |
Merz Pharmaceuticals GmbH |
— |
| Increlex 10 mg/ml solution for injection EU/1/07/402/001 |
Mecasermin |
Esteve Pharmaceuticals S.A. |
— |
| INREBIC 100 mg hard capsules EU/1/20/1514/001 |
Fedratinib dihydrochloride monohydrate, Fedratinib |
Bristol-Myers Squibb Pharmaceuticals uc |
— |
| Intuniv 1 mg prolonged-release tablets EU/1/15/1040/001-002 |
GUANFACINE HYDROCHLORIDE |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Intuniv 2 mg prolonged-release tablets EU/1/15/1040/003-005 |
GUANFACINE HYDROCHLORIDE |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Intuniv 3 mg prolonged-release tablets EU/1/15/1040/006-007 |
GUANFACINE HYDROCHLORIDE |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Intuniv 4 mg prolonged-release tablets EU/1/15/1040/008-009 |
GUANFACINE HYDROCHLORIDE |
Takeda Pharmaceuticals International AG Ireland Branch |
— |
| Ipratropium bromide/salbutamol Azure 0.5 mg/2.5 mg per 2.5 ml Nebuliser Solution PA22871/033/001 |
Ipratropium bromide monohydrate, Salbutamol sulfate |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Irbesartan Rowa 150 mg tablets PA0074/080/002 |
Irbesartan |
Rowa Pharmaceuticals Limited |
Marketed |
| Irbesartan Rowa 300 mg tablets PA0074/080/003 |
Irbesartan |
Rowa Pharmaceuticals Limited |
Marketed |
| Irbesartan Rowa 75 mg tablets PA0074/080/001 |
Irbesartan |
Rowa Pharmaceuticals Limited |
Marketed |
| Itraconazole 10mg/ml oral solution PA1418/004/001 |
Itraconazole |
Athlone Pharmaceuticals Limited |
Not marketed |
| JERAYGO 12.5 mg film-coated tablets EU/1/24/1818/001-002 |
Aprocitentan |
Idorsia Pharmaceuticals Deutschland GmbH |
— |
| JERAYGO 25 mg film-coated tablets EU/1/24/1818/003-004 |
Aprocitentan |
Idorsia Pharmaceuticals Deutschland GmbH |
— |
| Kaftrio 37.5 mg/25 mg/50 mg film-coated tablets EU/1/20/1468/002 |
Ivacaftor, TEZACAFTOR, Elexacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kaftrio 60 mg/40 mg/80 mg granules in sachet EU/1/20/1468/003 |
Elexacaftor, TEZACAFTOR, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kaftrio 75 mg/50 mg/100 mg film-coated tablets EU/1/20/1468/001 |
TEZACAFTOR, Ivacaftor, VX-445 |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kaftrio 75 mg/50 mg/100 mg granules in sachet EU/1/20/1468/004 |
Elexacaftor, TEZACAFTOR, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 13.4 mg granules in sachet EU/1/12/782/010-011 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 150 mg film-coated tablets EU/1/12/782/001-002 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 150 mg film-coated tablets EU/1/12/782/005 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 50 mg granules in sachet EU/1/12/782/003 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 59.5 mg granules in sachet EU/1/12/782/008 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 75 mg film-coated tablets EU/1/12/782/007 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kalydeco 75 mg granules in sachet EU/1/12/782/004 |
Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Kapake 15mg/500mg Tablets PA1418/020/001 |
Paracetamol, Codeine phosphate hemihydrate |
Athlone Pharmaceuticals Limited |
Not marketed |
| Kapake 30 mg/500 mg Tablets PA1418/020/002 |
Paracetamol, Codeine phosphate hemihydrate |
Athlone Pharmaceuticals Limited |
Not marketed |
| Ketoconazole Esteve 200 mg tablets EU/1/14/965/001 |
Ketoconazole |
Esteve Pharmaceuticals S.A. |
— |
| Kopen 250mg Tablets PA1418/014/003 |
Phenoxymethylpenicillin potassium |
Athlone Pharmaceuticals Limited |
Marketed |
| Kopen Sugar Free 125 mg/5 ml Powder for Oral Solution PA1418/014/001 |
Phenoxymethylpenicillin |
Athlone Pharmaceuticals Limited |
Marketed |
| Kopen Sugar Free 250 mg/5 ml Powder for Oral Solution PA1418/014/002 |
Phenoxymethylpenicillin |
Athlone Pharmaceuticals Limited |
Marketed |
| Lamictal 100 mg Tablets PPA23080/014/002 |
Lamotrigine |
Merit Pharmaceuticals Limited |
— |
| Lamictal 25 mg tablets PPA23080/014/001 |
Lamotrigine |
Merit Pharmaceuticals Limited |
— |
| Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel PA23144/001/001 |
Levodopa, Carbidopa monohydrate, Entacapone |
Lobsor Pharmaceuticals AB |
Marketed |
| Ledaga 160 micrograms/g gel EU/1/16/1171/001 |
Chlormethine hydrochloride |
Helsinn Birex Pharmaceuticals Limited |
— |
| Lenalidomide Mylan 10 mg hard capsules EU/1/20/1490/009-010 |
Lenalidomide |
Mylan Pharmaceuticals Limited |
— |
| Lenalidomide Mylan 15 mg hard capsules EU/1/20/1490/011-012 |
Lenalidomide |
Mylan Pharmaceuticals Limited |
— |
| Lenalidomide Mylan 2.5 mg hard capsules EU/1/20/1490/001-003 |
Lenalidomide |
Mylan Pharmaceuticals Limited |
— |
| Lenalidomide Mylan 25 mg hard capsules EU/1/20/1490/016-018 |
Lenalidomide |
Mylan Pharmaceuticals Limited |
— |
| Lenalidomide Mylan 5 mg hard capsules EU/1/20/1490/004-005 |
Lenalidomide |
Mylan Pharmaceuticals Limited |
— |
| Lenalidomide Mylan 7.5 mg hard capsules EU/1/20/1490/006-008 |
Lenalidomide |
Mylan Pharmaceuticals Limited |
— |
| Lescol XL 80 mg Prolonged-release tablets PA23517/001/001 |
Fluvastatin sodium |
Ethyx Pharmaceuticals |
Marketed |
| Letrozole Bluefish 2.5 mg film-coated tablets PA1436/013/001 |
Letrozole |
Bluefish Pharmaceuticals AB |
Marketed |
| Lipocomb 10 mg/10 mg hard capsules PA1470/004/001 |
Ezetimibe, Rosuvastatin zinc tetrahydrate |
EGIS Pharmaceuticals PLC |
Not marketed |
| Lipocomb 20 mg/10 mg hard capsules PA1470/004/002 |
Ezetimibe, Rosuvastatin zinc tetrahydrate |
EGIS Pharmaceuticals PLC |
Not marketed |
| Lipocomb 40 mg/10 mg hard capsules PA1470/004/003 |
Ezetimibe, Rosuvastatin zinc tetrahydrate |
EGIS Pharmaceuticals PLC |
Marketed |
| Livmarli 9.5 mg/mL oral solution EU/1/22/1704/001 |
Maralixibat Chloride |
Mirum Pharmaceuticals International B.V. |
— |
| LIVTENCITY 200 mg film-coated tablets EU/1/22/1672/001-002 |
Maribavir |
Takeda Pharmaceuticals International AG Ireland Branch |
— |