| OPDIVO 10 mg/mL concentrate for solution for infusion EU/1/15/1014/001-004 |
Nivolumab |
Bristol-Myers Squibb Pharma EEIG |
— |
| OPDIVO 600 mg solution for injection EU/1/15/1014/005 |
Nivolumab |
Bristol-Myers Squibb Pharma EEIG |
— |
| Opdualag 240 mg/80 mg sterile concentrate EU/1/22/1679/001 |
RELATLIMAB, Nivolumab |
Bristol-Myers Squibb Pharma EEIG |
— |
| Opfolda 65 mg hard capsules EU/1/23/1737/001-002 |
Miglustat |
Amicus Therapeutics Europe Limited |
— |
| Oprymea 0.088 mg tablets EU/1/08/469/1-5 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 0.18 mg tablets EU/1/08/469/6-10 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 0.26 mg prolonged-release tablets EU/1/08/469/026-029 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 0.35 mg tablets EU/1/08/469/11-15 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 0.52 mg prolonged-release tablets EU/1/08/469/030-033 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 0.7 mg tablets EU/1/08/469/16-20 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 1.05 mg prolonged-release tablets EU/1/08/469/034-037 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 1.1 mg tablets EU/1/08/469/21-25 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 1.57 mg prolonged-release tablets EU/1/08/469/038-041 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 2.1 mg prolonged-release tablets EU/1/08/469/042-045 |
Pramipexole |
KRKA, d.d., Novo mesto |
— |
| Oprymea 2.62 mg prolonged-release tablets EU/1/08/469/046-049 |
Pramipexole dihydrochloride monohydrate |
KRKA, d.d., Novo mesto |
— |
| Oprymea 3.15 mg prolonged-release tablets EU/1/08/469/050-053 |
Pramipexole dihydrochloride monohydrate |
KRKA, d.d., Novo mesto |
— |
| Opsaren 10 mg Film-coated Tablets PA22865/018/001 |
Macitentan |
Renata Pharmaceuticals (Ireland) Limited |
Not marketed |
| Opsumit 10 mg film-coated tablets EU/1/13/893/001-002 |
Macitentan |
Janssen Pharmaceutica NV |
— |
| Opsumit 2.5 mg film-coated tablets EU/1/13/893/004 |
Macitentan |
Janssen Pharmaceutica NV |
— |
| Opticrom 2 % w/v Eye Drops, solution PA0126/381/001 |
Sodium cromoglicate |
Clonmel Healthcare Ltd |
Not marketed |
| Opticrom allergy 2% w/v eye drops, solution PA0126/381/002 |
Sodium cromoglicate |
Clonmel Healthcare Ltd |
Marketed |
| Opticrom Allergy Single Dose 2% w/v eye drops, solution PA0126/381/003 |
Sodium cromoglicate |
Clonmel Healthcare Ltd |
Marketed |
| Optilast, 0.5 mg/ml Eye Drops, solution PA25506/009/001 |
Azelastine hydrochloride |
Cooper Consumer Health B.V. |
Not marketed |
| Optiray 300 mg I/ml PFS solution for injection PA0686/007/004 |
Ioversol |
Guerbet |
Marketed |
| Optiray 300 mg I/ml solution for injection or infusion PA0686/007/003 |
Ioversol |
Guerbet |
Marketed |
| Optiray 320 mg I/ml solution for injection or infusion PA0686/007/005 |
Ioversol |
Guerbet |
Not marketed |
| Optiray 350 mg I/ml PFS solution for injection PA0686/007/007 |
Ioversol |
Guerbet |
Marketed |
| Optiray 350 mg I/ml solution for injection or infusion PA0686/007/006 |
Ioversol |
Guerbet |
Marketed |
| OPTISON 0.19 mg/ml dispersion for injection EU/1/98/065/001 |
Perflutren, Human albumin microspheres |
GE Healthcare AS |
— |
| OPTISON 0.19 mg/ml dispersion for injection EU/1/98/065/002 |
Perflutren, Human albumin microspheres |
GE Healthcare AS |
— |
| Optrex Clear Eyes Eye Drops Solution Hamamelis Water 12.5% v/v Naphazoline Hydrochloride 0.01% w/v PA0979/079/001 |
Hamamelis water, Naphazoline hydrochloride |
Reckitt Benckiser Ireland Limited |
Not marketed |
| Optruma 60 mg film coated tablets EU/1/98/074/001 |
Raloxifene |
Eli Lilly Nederland B.V. |
— |
| Optruma 60 mg film coated tablets EU/1/98/074/002 |
Raloxifene |
Eli Lilly Nederland B.V. |
— |
| Optruma 60 mg film coated tablets EU/1/98/074/003 |
Raloxifene |
Eli Lilly Nederland B.V. |
— |
| Optruma 60 mg film coated tablets EU/1/98/074/004 |
Raloxifene |
Eli Lilly Nederland B.V. |
— |
| Opuviz 40 mg/mL solution for injection in a vial EU/1/24/1865/001-002 |
Aflibercept |
Samsung Bioepis NL B.V. |
— |
| Opzelura 15 mg/g Cream EU/1/23/1726/001 |
Ruxolitinib |
Incyte Biosciences Distribution B.V. |
— |
| Oralair 100IR & 300IR sublingual tablets PA2113/001/001 |
Grass pollen allergen extract |
Stallergenes |
Marketed |
| Oralair 300 IR sublingual tablets PA2113/001/002 |
Grass pollen allergen extract |
Stallergenes |
Marketed |
| Oraldene 0.1% w/v Gargle/Mouthwash PA23490/009/001 |
Hexetidine |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Oraldene Icemint 0.1% w/v Gargle/Mouthwash Hexetidine PA23490/009/002 |
Hexetidine |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Oramorph Concentrated oral solution 20 mg/ml PA2256/004/002 |
Morphine sulfate |
Glenwood GmbH |
Marketed |
| Oramorph Oral Solution 10 mg/5 ml PA2256/004/001 |
Morphine sulfate |
Glenwood GmbH |
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 |
| Oraqix 25/25 mg per g Periodontal gel PA1045/004/001 |
Lidocaine, Prilocaine |
DENTSPLY DeTrey GmbH |
Marketed |
| Ordspono 2 mg Concentrate for solution for infusion EU/1/24/1843/001 |
Odronextamab |
Regeneron Ireland Designated Activity Company |
— |
| Ordspono 320 mg Concentrate for solution for infusion EU/1/24/1843/003 |
Odronextamab |
Regeneron Ireland Designated Activity Company |
— |