| Olazax Disperzi 15 mg orodispersible tablets EU/1/09/592/004 |
Olanzapine |
Glenmark Pharmaceuticals s.r.o. |
— |
| Olazax Disperzi 20 mg orodispersible tablets EU/1/09/592/005 |
Olanzapine |
Glenmark Pharmaceuticals s.r.o. |
— |
| Olazax Disperzi 5 mg orodispersible tablets EU/1/09/592/001 |
Olanzapine |
Glenmark Pharmaceuticals s.r.o. |
— |
| Omeprazole Bluefish 10 mg gastro-resistant capsules PA1436/007/001 |
Omeprazole |
Bluefish Pharmaceuticals AB |
Marketed |
| Omeprazole Bluefish 20 mg gastro-resistant capsules PA1436/007/002 |
Omeprazole |
Bluefish Pharmaceuticals AB |
Marketed |
| Omeprazole Bluefish 40 mg gastro-resistant capsules PA1436/007/003 |
Omeprazole |
Bluefish Pharmaceuticals AB |
Marketed |
| Omeprazole Rowa 20 mg Gastro-resistant Capsules, hard PA0074/075/002 |
Omeprazole |
Rowa Pharmaceuticals Limited, |
Marketed |
| Omeprazole Rowa 40 mg Gastro-Resistant Capsules, hard PA0074/075/003 |
Omeprazole |
Rowa Pharmaceuticals Limited, |
Marketed |
| Opsaren 10 mg Film-coated Tablets PA22865/018/001 |
Macitentan |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Oramox 125 mg/5 ml powder for oral suspension PA1418/013/001 |
Amoxicillin |
Athlone Pharmaceuticals Limited |
Marketed |
| Oramox 250 mg hard capsules PA1418/013/003 |
Amoxicillin |
Athlone Pharmaceuticals Limited |
Marketed |
| Oramox 250 mg/5 ml powder for oral suspension PA1418/013/002 |
Amoxicillin |
Athlone Pharmaceuticals Limited |
Marketed |
| Oramox 500 mg hard capsules PA1418/013/004 |
Amoxicillin |
Athlone Pharmaceuticals Limited |
Marketed |
| Orkambi 100 mg/125 mg film-coated tablets EU/1/15/1059/005 |
Lumacaftor, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Orkambi 100 mg/125 mg granules in sachet EU/1/15/1059/006 |
Lumacaftor, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Orkambi 150 mg/188 mg granules in sachet EU/1/15/1059/007 |
Ivacaftor, Lumacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Orkambi 200 mg/125 mg film-coated tablets EU/1/15/1059/001 |
Lumacaftor, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| Orkambi 75 mg/94 mg granules in sachet EU/1/15/1059/008 |
Lumacaftor, Ivacaftor |
Vertex Pharmaceuticals (Ireland) Limited |
— |
| OxyContin 10 mg prolonged release tablets PA1688/005/002 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyContin 20 mg prolonged release tablets PA1688/005/003 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyContin 40 mg prolonged release tablets PA1688/005/004 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyContin 5 mg prolonged release tablets PA1688/005/001 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyContin 80 mg prolonged release tablets PA1688/005/005 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Not marketed |
| OxyNorm 10 mg hard capsules PA1688/006/005 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm 10 mg/ml, solution for injection or infusion PA1688/006/001 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm 20 mg hard capsules PA1688/006/006 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm 5 mg hard capsules PA1688/006/004 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm 50 mg/ml, solution for injection or infusion PA1688/006/010 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm concentrate 10 mg/ml oral solution PA1688/006/003 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm Dispersa 10 mg Orodispersible Tablets PA1688/006/008 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm Dispersa 20 mg orodispersible tablets PA1688/006/009 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm Dispersa 5 mg Orodispersible Tablets PA1688/006/007 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| OxyNorm liquid 1 mg/ml oral solution PA1688/006/002 |
OXYCODONE HYDROCHLORIDE |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Palladone 1.3 mg hard capsules PA1688/007/001 |
Hydromorphone hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Palladone 2.6 mg hard capsules PA1688/007/002 |
Hydromorphone hydrochloride |
Mundipharma Pharmaceuticals Limited |
Not marketed |
| Palladone SR 2 mg prolonged release hard capsules PA1688/007/007 |
Hydromorphone hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Palladone SR 4 mg prolonged release hard capsules PA1688/007/008 |
Hydromorphone hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Palladone SR 8 mg prolonged release hard capsules, PA1688/007/009 |
Hydromorphone hydrochloride |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Pantoprazole Bluefish 20 mg gastro-resistant tablets PA1436/008/001 |
Pantoprazole sodium sesquihydrate |
Bluefish Pharmaceuticals AB |
Marketed |
| Pantoprazole Bluefish 40 mg gastro-resistant tablets PA1436/008/002 |
Pantoprazole sodium sesquihydrate |
Bluefish Pharmaceuticals AB |
Marketed |
| Pantup 20 mg gastro-resistant tablets PA0074/069/001 |
Pantoprazole |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Pantup 40 mg gastro-resistant tablets PA0074/069/002 |
Pantoprazole |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Paracetamol 500 mg Capsules, hard PA22871/016/001 |
Paracetamol |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Paracetamol 500 mg tablets PA1436/040/001 |
Paracetamol |
Bluefish Pharmaceuticals AB |
Not marketed |
| Paracetamol/Ibuprofen 1000 mg/300mg powder for oral solution in sachet PA25595/001/002 |
Paracetamol, Ibuprofen lysine |
Aft Pharmaceuticals (Eur) Limited |
Not marketed |
| Paracetamol/Ibuprofen 500 mg/150 mg powder for oral solution in sachet PA25595/001/001 |
Paracetamol, Ibuprofen lysine |
Aft Pharmaceuticals (Eur) Limited |
Not marketed |
| Paracetamol/Ibuprofen Vale 1000 mg/300mg powder for oral solution in sachet PA1535/018/002 |
Paracetamol, Ibuprofen lysine |
Vale Pharmaceuticals Limited |
Not marketed |
| Paracetamol/Ibuprofen Vale 500 mg/150 mg powder for oral solution in sachet PA1535/018/001 |
Paracetamol, Ibuprofen lysine |
Vale Pharmaceuticals Limited |
Not marketed |
| Paxneury 1 mg prolonged-release tablets EU/1/24/1908/001 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Paxneury 2 mg prolonged-release tablets EU/1/24/1908/002 |
Guanfacine hydrochloride |
Neuraxpharm Pharmaceuticals S.L. |
— |