| Riximyo 100 mg concentrate for solution for infusion EU/1/17/1184/001-002 |
Rituximab |
Sandoz GmbH |
— |
| Riximyo 500 mg concentrate for solution for infusion EU/1/17/1184/003-004 |
Rituximab |
Sandoz GmbH |
— |
| RIXUBIS 1000 IU powder and solvent for solution for injection EU/1/14/970/003 |
Nonacog gamma |
Baxter Innovations GmbH |
— |
| RIXUBIS 2000 IU powder and solvent for solution for injection EU/1/14/970/004 |
Nonacog gamma |
Baxter Innovations GmbH |
— |
| RIXUBIS 250 IU powder and solvent for solution for injection EU/1/14/970/001 |
Nonacog gamma |
Baxter Innovations GmbH |
— |
| RIXUBIS 3000 IU powder and solvent for solution for injection EU/1/14/970/005 |
Nonacog gamma |
Baxter Innovations GmbH |
— |
| RIXUBIS 500 IU powder and solvent for solution for injection EU/1/14/970/002 |
Nonacog gamma |
Baxter Innovations GmbH |
— |
| Rizadia 5 mg oral lyophilisate PA23198/027/001 |
Rizatriptan benzoate |
Organon Pharma (Ireland) Limited |
Not marketed |
| Rizadia 5 mg Tablets PA23198/027/002 |
Rizatriptan benzoate |
Organon Pharma (Ireland) Limited |
Not marketed |
| Rizmoic 200 microgram Film-coated tablet EU/1/18/1291/001-003 |
Naldemedine tosilate |
Shionogi B.V. |
— |
| Roaccutane 10 mg soft capsules PA25306/001/001 |
Isotretinoin |
Cheplapharm Registration GmbH |
Marketed |
| Roaccutane 20 mg soft capsules PA25306/001/002 |
Isotretinoin |
Cheplapharm Registration GmbH |
Marketed |
| RoActemra 162 mg Solution for injection EU/1/08/492/007-008 |
Tocilizumab |
Roche Registration GmbH |
— |
| RoActemra 162 mg Solution for injection EU/1/08/492/009-010 |
Tocilizumab |
Roche Registration GmbH |
— |
| RoActemra 20 mg/ml Concentrate for solution for infusion EU/1/08/492/001-006 |
Tocilizumab |
Roche Registration GmbH |
— |
| Robitussin Chesty Cough 100mg/5ml Oral Solution PA0678/153/001 |
Guaifenesin |
Haleon Ireland Limited |
Marketed |
| Robitussin Dry Cough 7.5mg/5ml Oral Solution PA0678/155/001 |
Dextromethorphan hydrobromide |
Haleon Ireland Limited |
Marketed |
| Robitussin Plus Oral Solution Guaifenesin 100 mg/5ml Pseudoephedrine HCl 30 mg/5ml PA0678/154/001 |
Guaiphenesin, PSEUDOEPHEDRINE HYDROCHLORIDE |
Haleon Ireland Limited |
Not marketed |
| Rocephin 1 g powder and solvent for IM injection only PA2307/008/002 |
Ceftriaxone sodium, Lidocaine Hydrochloride Monohydrate |
Roche Products (Ireland) Ltd |
Marketed |
| Rocephin 1 g powder for solution for injection/infusion PA2307/008/003 |
Ceftriaxone sodium |
Roche Products (Ireland) Ltd |
Marketed |
| Roclanda 50 micrograms/ml + 200 micrograms/ml eye drops, solution EU/1/20/1502/001 |
NETARSUDIL MESILATE, NETARSUDIL, Latanoprost |
Santen OY |
— |
| ROCTAVIAN 2 × 10^13 vector genomes/mL solution for infusion EU/1/22/1668/001 |
Valoctocogene Roxaparvovec |
Biomarin International Limited |
— |
| Rocuronium 10 mg/ml solution for injection/infusion PA0736/029/001 |
Rocuronium bromide |
B. Braun Melsungen AG |
Marketed |
| Rocuronium 10 mg/ml solution for injection/infusion PA2059/018/001 |
Rocuronium bromide |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Rocuronium bromide 10 mg/mL solution for injection in pre-filled syringe PA1968/015/001 |
Rocuronium bromide |
Laboratoire Aguettant |
Marketed |
| Rocuronium bromide 10 mg/ml solution for injection/infusion PA2165/004/001 |
Rocuronium bromide |
AS Kalceks |
Marketed |
| Rocuronium bromide 10 mg/mL Solution for injection/infusion PA1122/022/001 |
Rocuronium bromide |
Noridem Enterprises Limited |
Not marketed |
| Rocuronium Bromide 10 mg/ml solution for Injection/Infusion PA1862/001/001 |
Rocuronium bromide |
Ibigen Srl |
Marketed |
| Rocuronium bromide Accord 10 mg/mL solution for injection in pre filled syringe PA2315/256/001 |
Rocuronium bromide |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Rolcya 60 mg solution for injection in pre-filled syringe EU/1/25/1958/001 |
Denosumab |
Sandoz GmbH |
— |
| Rolpryna SR 2 mg prolonged-release tablets PA1347/012/001 |
Ropinirole hydrochloride |
KRKA, d.d., Novo mesto |
Marketed |
| Rolpryna SR 4 mg prolonged-release tablets PA1347/012/002 |
Ropinirole hydrochloride |
KRKA, d.d., Novo mesto |
Marketed |
| Rolpryna SR 8 mg prolonged-release tablets PA1347/012/003 |
Ropinirole hydrochloride |
KRKA, d.d., Novo mesto |
Marketed |
| Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed EU/1/17/1174/001-003 |
Umeclidinium bromide |
GlaxoSmithKline Trading Services Limited |
— |
| Rolyprexa 10 mg film-coated tablets PA0711/124/004 |
Olanzapine |
Rowex Ltd |
Marketed |
| Rolyprexa 2.5 mg film-coated tablets PA0711/124/001 |
Olanzapine |
Rowex Ltd |
Not marketed |
| Rolyprexa 5 mg film-coated tablets PA0711/124/002 |
Olanzapine |
Rowex Ltd |
Marketed |
| Rolyprexa 7.5 mg film-coated tablets PA0711/124/003 |
Olanzapine |
Rowex Ltd |
Marketed |
| Romax Once Weekly 70mg Tablets PA1445/017/001 |
Alendronic acid |
Aurobindo Pharma (Malta) Limited |
Marketed |
| 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. |
— |
| Ropivacaine 2 mg/ml solution for injection PA2059/021/001 |
Ropivacaine Hydrochloride |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Ropivacaine 7.5 mg/ml solution for injection PA2059/021/002 |
Ropivacaine Hydrochloride |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Ropivacaine Readyfusor 10 mg/h solution for infusion in administration system PA2284/001/001 |
Ropivacaine hydrochloride monohydrate |
BioQ Pharma B.V. |
— |
| Rosuva 10 mg film-coated tablets PA0711/176/002 |
Rosuvastatin |
Rowex Limited, |
Marketed |
| Rosuva 20 mg film-coated tablets PA0711/176/003 |
Rosuvastatin |
Rowex Limited, |
Marketed |
| Rosuva 40 mg film-coated tablets PA0711/176/004 |
Rosuvastatin |
Rowex Limited, |
Marketed |
| Rosuva 5 mg film-coated tablets PA0711/176/001 |
Rosuvastatin |
Rowex Limited, |
Marketed |
| Rosuvastatin 10 mg film-coated tablets PA23266/073/002 |
Rosuvastatin |
Viatris Limited |
Not marketed |