| Onglyza 2.5 mg & 5 mg film-coated tablets | - |  24/08/18 |  23/08/18 | Saxagliptin hydrochloride | AstraZeneca Pharmaceuticals (Ireland) DAC |
| Opatanol 1mg/ml eye drops solution | - | 10/04/19 | 08/04/19 | Olopatadine (as hydrochloride) | Novartis Ireland Limited |
| OPDIVO 10 mg/mL concentrate for solution for infusion | | 23/10/19 | 04/11/19 | Nivolumab | Bristol-Myers Squibb Pharma EEIG |
| Opsumit 10mg | - | 06/12/18 | 05/10/18 | Macitentan | Actelion Pharmaceuticals UK Ltd |
| Opticrom 2% w/v Eye Drops Solution | - | 12/12/16 | 07/08/17 | Sodium Cromoglicate | SANOFI |
| Opticrom Allergy 2%w/v Eye Drops, Solution | - | 14/03/18 | 11/12/18 | Sodium Cromoglicate | SANOFI |
| Opticrom Allergy Single Dose 2%w/v Eye Drops, solution | - | 11/05/17 | 16/05/17 | Sodium Cromoglicate | SANOFI |
| Optrex Clear Eyes Eye Drops | - | 22/11/18 | 19/01/18 | Hamamelis, Naphazoline Hydrochloride | Reckitt Benckiser Ireland Limited |
| Oraldene 0.1% w/v Gargle / Mouthwash | - | 03/04/19 | 03/04/19 | Hexetidine | Johnson & Johnson (Ireland) Ltd |
| Oraldene Icemint 0.1% w/v Gargle / Mouthwash | - | 03/04/19 | 03/04/19 | Hexetidine | Johnson & Johnson (Ireland) Ltd |
| Oramorph Concentrated Oral Solution | - | 25/04/19 | 05/04/19 | Morphine sulfate | Boehringer Ingelheim Limited |
| Oramorph Oral Solution | - | 25/04/19 | 05/04/19 | Morphine sulfate | Boehringer Ingelheim Limited |
| ORENCIA 125 mg solution for injection in pre-filled pen | - | 17/04/19 | 17/04/19 | Abatacept | Bristol-Myers Squibb Pharma EEIG |
| ORENCIA 250 mg powder for concentrate for solution for infusion | - | 17/04/19 | 17/04/19 | Abatacept | Bristol-Myers Squibb Pharma EEIG |
| ORENCIA 50 mg, 87.5 mg and 125 mg solution for injection (pre-filled syringe) | - | 17/04/19 | 17/04/19 | Abatacept | Bristol-Myers Squibb Pharma EEIG |
| Orfadin 2mg, 5mg, 10mg and 20mg Capsules | - | 29/04/19 | 26/04/19 | Nitisinone | Swedish Orphan Biovitrum Ltd |
| Orfadin 4mg/ml Oral Suspension | - | 29/04/19 | 26/04/19 | Nitisinone | Swedish Orphan Biovitrum Ltd |
| Orgalutran | - | 12/06/19 | 11/06/19 | Ganirelix | MSD Ireland (Human Health) Limited |
| Orgaran 750 anti-Xa units/0.6ml Solution for injection | - | 21/06/16 | 11/07/16 | Danaparoid Sodium | Aspen |
| Orkambi 100 mg/125 mg granules and 150 mg/188 mg granules | | 08/02/19 | 08/02/19 | Ivacaftor, Lumacaftor | Vertex Pharmaceuticals (Ireland) Limited |
| Orkambi 200 mg/125 mg tablets and 100mg/125mg tablets | | 08/02/19 | 08/02/19 | Ivacaftor, Lumacaftor | Vertex Pharmaceuticals (Ireland) Limited |
| Oruvail 200mg Prolonged Release Capsules, Hard | - | 02/02/17 | 06/02/17 | Ketoprofen | SANOFI |
| Osmohale Inhalation Powder, Hard Capsule | - | 21/03/19 | 21/03/19 | Mannitol | Pharmaxis Europe Limited |
| Osteofos D3 | - | 04/05/17 | 04/05/17 | Calcium phosphate, Colecalciferol (Vitamin D3) | A. Menarini Pharmaceuticals Ireland Ltd |
| Otezla 10mg, 20mg, 30mg | - | 06/09/19 | 25/10/19 | Apremilast | Celgene Ltd |
