| Obgemsa 75 mg film-coated tablets EU/1/24/1822/001-006 |
Vibegron |
Pierre Fabre Medicament |
— |
| OBIZUR 500 U powder and solvent for solution for injection EU/1/15/1035/001-003 |
Susoctocog alfa |
Baxter Innovations GmbH |
— |
| Obodence 60 mg solution for injection in pre-filled syringe EU/1/24/1890/001 |
Denosumab |
Samsung Bioepis NL B.V. |
— |
| Ocaliva EU/1/16/1139/001 |
Obeticholic acid |
Advanz Pharma Limited |
— |
| Ocaliva EU/1/16/1139/002 |
Obeticholic acid |
Advanz Pharma Limited |
— |
| Occlusal 26% w/w Cutaneous Solution PA2325/011/001 |
Salicylic acid |
Alliance Pharma (Ireland) Limited |
Not marketed |
| Ocrevus 300 mg concentrate for solution for infusion EU/1/17/1231/001-002 |
Ocrelizumab |
Roche Registration GmbH |
— |
| Ocrevus 920 mg solution for injection EU/1/17/1231/003 |
Ocrelizumab |
Roche Registration GmbH |
— |
| Octanate 1000 IU powder and solvent for solution for injection PA2219/004/003 |
Human coagulation factor viii |
Octapharma (IP) |
Not marketed |
| Octanate 250 IU.Powder and solvent for solution for injection PA2219/004/001 |
Human plasmafraktion (factor viii) |
Octapharma (IP) |
Not marketed |
| Octanate 500 IU powder and solvent for solution for injection PA2219/004/002 |
Human coagulation factor viii |
Octapharma (IP) |
Not marketed |
| Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex PA2219/005/002 |
Human coagulation factor ix, Human coagulation factor ii, Human coagulation factor vii, Human coagulation factor x, Protein c |
Octapharma (IP) |
Marketed |
| Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin Complex PA2219/005/001 |
Human plasma coagulation factor ix, Human plasma coagulation factor ii, Human plasma coagulation factor vii, Human plasma coagulation factor x, Protein c |
Octapharma (IP) |
Marketed |
| Octreoscan 111 MBq/mL, kit for radiopharmaceutical preparation PA0690/001/001 |
Indium (111 in) chloride solution, Pentetreotide |
Curium Netherlands B.V. |
Marketed |
| Octreotide 100 micrograms/1 ml solution for injection PA0822/218/002 |
Octreotide acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Octreotide 50 micrograms/1 ml solution for injection PA0822/218/001 |
Octreotide acetate |
Pfizer Healthcare Ireland Unlimited Company |
Not marketed |
| Octreotide 500 micrograms/1 ml solution for injection PA0822/218/004 |
Octreotide acetate |
Pfizer Healthcare Ireland Unlimited Company |
Marketed |
| Oczyesa 20 mg prolonged-release solution for injection in pre-filled pen EU/1/25/1938/001 |
Octreotide hydrochloride |
Camurus AB |
— |
| Odefsey 200 mg/25 mg/25 mg film-coated tablets EU/1/16/1112/001-002 |
Emtricitabine, Rilpivirine, Tenofovir alafenamide |
Gilead Sciences Ireland UC |
— |
| Odomzo 200 mg hard capsules EU/1/15/1030/001-002 |
Sonidegib |
Sun Pharmaceutical Industries Europe B.V. |
— |
| Odrik 1mg Hard Capsules PA23355/037/001 |
Trandolapril |
Viatris Healthcare Limited |
Marketed |
| Odrik 2mg Hard Capsules PA23355/037/002 |
Trandolapril |
Viatris Healthcare Limited |
Marketed |
| Oestrogel Pump-Pack 750 micrograms/actuation Gel PA1054/004/001 |
Estradiol hemihydrate |
Laboratoires Besins International |
Marketed |
| Ofev 100 mg Soft capsule EU/1/14/979/001-002 |
Nintedanib |
Boehringer Ingelheim International GmbH |
— |
| Ofev 150 mg Soft capsule EU/1/14/979/003-004 |
Nintedanib |
Boehringer Ingelheim International GmbH |
— |
| Ofev 25mg Soft capsule EU/1/14/979/009-012 |
Nintedanib esylate |
Boehringer Ingelheim International GmbH |
— |
| Ofost 10 IU/ml concentrate for solution for infusion or solution for intramuscular injection PA22992/001/002 |
Oxytocin |
AS Grindeks |
Marketed |
| Ofost 5 IU/ml concentrate for solution for infusion or solution for intramuscular injection PA22992/001/001 |
Oxytocin |
AS Grindeks |
Marketed |
| Ogivri 150 mg powder for concentrate for solution for infusion EU/1/18/1341/001 |
Trastuzumab |
Biosimilar Collaborations Ireland Limited |
— |
| Ogivri 420 mg powder for concentrate for solution for infusion EU/1/18/1341/002 |
Trastuzumab |
Biosimilar Collaborations Ireland Limited |
— |
| Ogluo 0.5 mg solution for injection in pre-filled pen EU/1/20/1523/001-002 |
GLUCAGON |
Strongbridge Dublin Limited |
— |
| Ogluo 0.5 mg solution for injection in pre-filled syringe EU/1/20/1523/003-004 |
GLUCAGON |
Strongbridge Dublin Limited |
— |
| Ogluo 1 mg solution for injection in pre-filled pen EU/1/20/1523/005-006 |
GLUCAGON |
Strongbridge Dublin Limited |
— |
| Ogluo 1 mg solution for injection in pre-filled syringe EU/1/20/1523/007-008 |
GLUCAGON |
Strongbridge Dublin Limited |
— |
| Ogsiveo 100 mg film‑coated tablets EU/1/25/1932/003 |
Nirogacestat hydrobromide |
Springworks Therapeutics Ireland Limited |
— |
| Ogsiveo 150 mg film‑coated tablets EU/1/25/1932/004 |
Nirogacestat hydrobromide |
Springworks Therapeutics Ireland Limited |
— |
| Ogsiveo 50 mg film‑coated tablets EU/1/25/1932/001-002 |
Nirogacestat hydrobromide |
Springworks Therapeutics Ireland Limited |
— |
| Oilatum Cream PA0126/321/001 |
Liquid paraffin light, White soft paraffin |
Clonmel Healthcare Ltd |
Not marketed |
| Oilatum Emollient 63.4% w/w Bath Additive PA0126/322/001 |
Liquid paraffin light |
Clonmel Healthcare Ltd |
Marketed |
| Oilatum Junior Flare-Up Bath Additive Light liquid paraffin 52.5% w/w Benzalkonium chloride 6.0% w/w Triclosan PA0126/323/001 |
Light liquid paraffin, Benzalkonium chloride, Triclosan |
Clonmel Healthcare Ltd |
Marketed |
| OKEDI 100 mg Powder and solvent for prolonged-release suspension for injection EU/1/21/1621/002 |
Risperidone |
Laboratorios Farmacéuticos ROVI, S.A. |
— |
| OKEDI 75 mg Powder and solvent for prolonged-release suspension for injection EU/1/21/1621/001 |
Risperidone |
Laboratorios Farmacéuticos ROVI, S.A. |
— |
| Olanzapine 10mg Film-coated Tablets PA0126/210/004 |
Olanzapine |
Clonmel Healthcare Ltd |
Marketed |
| Olanzapine 10mg Orodispersible Tablets PA2315/229/002 |
Olanzapine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Olanzapine 15mg Film-coated Tablets PA0126/210/005 |
Olanzapine |
Clonmel Healthcare Ltd |
Marketed |
| Olanzapine 15mg Orodispersible Tablets PA2315/229/003 |
Olanzapine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Olanzapine 2.5mg Film-coated Tablets PA0126/210/001 |
Olanzapine |
Clonmel Healthcare Ltd |
Marketed |
| Olanzapine 20mg Film-coated Tablets PA0126/210/006 |
Olanzapine |
Clonmel Healthcare Ltd |
Marketed |
| Olanzapine 20mg Orodispersible Tablets PA2315/229/004 |
Olanzapine |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Olanzapine 5 mg Orodispersible Tablets PA2315/229/001 |
Olanzapine |
Accord Healthcare Ireland Ltd. |
Not marketed |