| 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 | - | 13/01/20 | 16/12/19 | Abatacept | Bristol-Myers Squibb Pharma EEIG |
| ORENCIA 250 mg powder for concentrate for solution for infusion | - | 13/01/20 | 16/12/19 | Abatacept | Bristol-Myers Squibb Pharma EEIG |
| ORENCIA 50 mg, 87.5 mg and 125 mg solution for injection (pre-filled syringe) | - | 23/01/20 | 16/12/19 | 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 | - | 09/04/20 | 09/04/20 | Apremilast | Amgen Ltd |
| Otrivine Adult 0.1% w/v Nasal Drops, Solution | - | 18/06/19 | 03/10/16 | Xylometazoline Hydrochloride | GlaxoSmithKline Consumer Healthcare (Ireland) Ltd |
| Otrivine Adult 0.1% w/v Nasal Spray, Solution | - | 18/06/19 | 11/02/20 | Xylometazoline Hydrochloride | GlaxoSmithKline Consumer Healthcare (Ireland) Ltd |
| Otrivine Adult Measured Dose Sinusitus 0.1% w/v Nasal Spray, Solution | - | 18/06/19 | 03/10/16 | Xylometazoline Hydrochloride | GlaxoSmithKline Consumer Healthcare (Ireland) Ltd |
| Otrivine Adult Mucus Relief Menthol, 0.1% w/v Nasal Spray | - | 08/08/19 | 04/10/16 | Xylometazoline Hydrochloride | GlaxoSmithKline Consumer Healthcare (Ireland) Ltd |
| Ovestin 1mg per gram Vaginal cream | - | 23/12/19 | 23/12/19 | Estriol | Aspen |
| Ovitrelle 250 micrograms/0.5 ml pre-filled pen | - | 01/11/18 | 26/10/18 | Choriogonadotropin alfa | Merck |
| Ovranette 150micrograms/30micrograms Coated Tablets | - | 04/11/19 | 31/10/19 | Ethinylestradiol, Levonorgestrel | Pfizer Healthcare Ireland |
| Ovreena 30 micrograms/150 micrograms coated tablets | - | 20/05/19 | 18/05/19 | Ethinylestradiol, Levonorgestrel | Consilient Health Ltd |
| Oxis Turbohaler 12mcg | - | 16/03/20 | 16/03/20 | Formoterol fumarate dihydrate | AstraZeneca Pharmaceuticals (Ireland) DAC |
| Oxis Turbohaler 6mcg | - | 16/03/20 | 16/03/20 | Formoterol fumarate dihydrate | AstraZeneca Pharmaceuticals (Ireland) DAC |
