| Rivaroxaban Bluefish 15 mg film-coated tablets PA1436/044/002 |
Rivaroxaban |
Bluefish Pharmaceuticals AB |
Not marketed |
| Rivaroxaban Bluefish 15 mg film-coated tablets Rivaroxaban Bluefish 20 mg film-coated tablets PA1436/044/004 |
Rivaroxaban, Rivaroxaban |
Bluefish Pharmaceuticals AB |
Not marketed |
| Rivaroxaban Bluefish 20 mg film-coated tablets PA1436/044/003 |
Rivaroxaban |
Bluefish Pharmaceuticals AB |
Not marketed |
| Rivaroxaban Rowa 10 mg film-coated tablets PA0074/097/001 |
Rivaroxaban |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Rivaroxaban Rowa 15 mg film-coated tablets PA0074/097/002 |
Rivaroxaban |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Rivaroxaban Rowa 20 mg film-coated tablets PA0074/097/003 |
Rivaroxaban |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Rivastigmine Sandoz 1.5 mg hard capsules EU/1/09/599/001-003 |
Rivastigmine hydrogen tartrate |
Sandoz Pharmaceuticals GmbH |
— |
| Rivastigmine Sandoz 2 mg/ml oral solution EU/1/09/599/017-018 |
Rivastigmine hydrogen tartrate |
Sandoz Pharmaceuticals GmbH |
— |
| Rivastigmine Sandoz 3 mg hard capsules EU/1/09/599/005-007 |
Rivastigmine hydrogen tartrate |
Sandoz Pharmaceuticals GmbH |
— |
| Rivastigmine Sandoz 4.5 mg hard capsules EU/1/09/599/009-011 |
Rivastigmine hydrogen tartrate |
Sandoz Pharmaceuticals GmbH |
— |
| Rivastigmine Sandoz 6 mg hard capsules EU/1/09/599/013-015 |
Rivastigmine hydrogen tartrate |
Sandoz Pharmaceuticals GmbH |
— |
| ROMVIMZA 14 mg hard capsules EU/1/25/1968/001 |
Vimseltinib |
Deciphera Pharmaceuticals (Netherlands) B.V. |
— |
| ROMVIMZA 20 mg hard capsules EU/1/25/1968/002 |
Vimseltinib |
Deciphera Pharmaceuticals (Netherlands) B.V. |
— |
| ROMVIMZA 30 mg hard capsules EU/1/25/1968/003 |
Vimseltinib |
Deciphera Pharmaceuticals (Netherlands) B.V. |
— |
| Rosuvastatin Rowa 10 mg film-coated tablets PA0074/093/002 |
Rosuvastatin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rosuvastatin Rowa 20 mg film-coated tablets PA0074/093/003 |
Rosuvastatin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rosuvastatin Rowa 40 mg film-coated tablets PA0074/093/004 |
Rosuvastatin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rosuvastatin Rowa 5 mg film-coated tablets PA0074/093/001 |
Rosuvastatin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rowachol Gastro-resistant Capsules, Soft PA0074/008/001 |
Menthol, Menthone, Alpha pinene, Borneol, Cineole |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rowachol Oral Drops, Solution PA0074/008/002 |
Alpha pinene, Borneol, Menthol, Beta pinene, Menthone |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Rowalief 500 mg Film-coated tablets PA0074/065/001 |
Paracetamol |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rowalief Max 1000 mg film-coated tablets PA0074/065/002 |
Paracetamol |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Rowarolan Cutaneous Powder PA0074/046/001 |
Calcium carbonate |
Rowa Pharmaceuticals Limited |
Marketed |
| Rowatanal Cream PA0074/016/001 |
Bismuth subgallate, Zinc oxide, Menthol |
Rowa Pharmaceuticals Limited |
Marketed |
| Rowatinex Gastro-resistant Capsules, Soft PA0074/009/001 |
Beta pinene, Cineole, Camphene, Alpha pinene, Fenchone |
Rowa Pharmaceuticals Limited, |
Marketed |
| Rowatinex Oral Drops, Solution PA0074/009/002 |
Anethol, Alpha pinene, Borneol, Fenchone, Camphene |
Rowa Pharmaceuticals Limited, |
Not marketed |
| Ryaltris 25 microgram/actuation + 600 microgram/actuation nasal spray, suspension PA1543/002/001 |
Mometasone furoate, Olopatadine |
Glenmark Pharmaceuticals s.r.o. |
Marketed |
| Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension for injection PA0869/008/001 |
Triptorelin |
Ipsen Pharmaceuticals Limited |
Not marketed |
| Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed PPA23080/028/001 |
Salmeterol, Fluticasone propionate |
Merit Pharmaceuticals Limited |
— |
| Seretide 500 Diskus 50 microgram/500 microgram/dose inhalation powder, pre-dispensed PPA23080/028/002 |
Salmeterol, Fluticasone propionate |
Merit Pharmaceuticals Limited |
— |
| Sertraline Bluefish 100 mg film-coated tablets PA1436/021/002 |
Sertraline |
Bluefish Pharmaceuticals AB |
Marketed |
| Sertraline Bluefish 50 mg film-coated tablets PA1436/021/001 |
Sertraline |
Bluefish Pharmaceuticals AB |
Marketed |
| Sevredol 10mg Film-Coated Tablets PA1688/009/001 |
Morphine sulfate |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Sevredol 20 mg Film-Coated Tablets PA1688/009/002 |
Morphine sulfate |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Simvastatin Bluefish 10 mg film-coated tablets PA1436/003/001 |
Simvastatin |
Bluefish Pharmaceuticals AB |
Marketed |
| Simvastatin Bluefish 20mg film-coated tablets PA1436/003/002 |
Simvastatin |
Bluefish Pharmaceuticals AB |
Marketed |
| Simvastatin Bluefish 40mg film-coated tablets PA1436/003/003 |
Simvastatin |
Bluefish Pharmaceuticals AB |
Marketed |
| Sitagliptin Rowa 100 mg film-coated tablets PA0074/089/003 |
Sitagliptin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Sitagliptin Rowa 25 mg film-coated tablets PA0074/089/001 |
Sitagliptin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Sitagliptin Rowa 50 mg film-coated tablets PA0074/089/002 |
Sitagliptin |
Rowa Pharmaceuticals Limited, |
Marketed |
| Sitagliptin/Metformin hydrochloride Mylan 50 mg/850 mg film-coated tablets EU/1/21/1619/001-008 |
Sitagliptin, Metformin Hydrochloride |
Mylan Pharmaceuticals Limited |
— |
| Sitagliptin/Metformin hydrochloride Rowa 50 mg/1000 mg film-coated tablets PA0074/090/002 |
Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride |
Rowa Pharmaceuticals Limited, |
Marketed |
| Sitagliptin/Metformin hydrochloride Rowa 50 mg/850 mg film-coated tablets PA0074/090/001 |
Metformin Hydrochloride, Sitagliptin Hydrochloride Monohydrate |
Rowa Pharmaceuticals Limited, |
Marketed |
| Slenyto 1 mg prolonged-release tablet EU/1/18/1318/001 |
Melatonin |
RAD Neurim Pharmaceuticals EEC SARL |
— |
| Slenyto 5 mg prolonged-release tablet EU/1/18/1318/003 |
Melatonin |
RAD Neurim Pharmaceuticals EEC SARL |
— |
| Sodium Nitrite Hope Pharmaceuticals 30 mg/mL Solution for Injection PA22874/001/001 |
SODIUM NITRITE |
Hope Pharmaceuticals Ltd |
Not marketed |
| Sodium Thiosulfate Hope Pharmaceuticals 250 mg/mL Solution for Injection PA22874/002/001 |
Sodium thiosulfate |
Hope Pharmaceuticals Ltd |
Not marketed |
| Somatuline Autogel 120mg, solution for injection in a pre-filled syringe PA0869/004/004 |
Lanreotide acetate |
Ipsen Pharmaceuticals Limited |
Marketed |
| Somatuline Autogel 60 mg, solution for injection in a prefilled syringe PA0869/004/002 |
Lanreotide acetate |
Ipsen Pharmaceuticals Limited |
Marketed |
| Somatuline Autogel 90mg, solution for injection in a pre-filled syringe PA0869/004/003 |
Lanreotide acetate |
Ipsen Pharmaceuticals Limited |
Marketed |