| Brufen 600mg film-coated tablets | - |  09/01/20 |  09/01/20 | Ibuprofen | Mylan IRE Healthcare Limited |
| Brufen Paediatric 100mg/5ml Oral Suspension | - | 09/01/20 | 09/01/20 | Ibuprofen | Mylan IRE Healthcare Limited |
| Brufen Retard 800mg prolonged release tablets | - | 09/01/20 | 09/01/20 | Ibuprofen | Mylan IRE Healthcare Limited |
| Buccolam 2.5mg, 5mg, 7.5mg and 10mg oromucosal solution | - | 27/10/18 | 04/11/19 | Midazolam Hydrochloride | Shire Pharmaceuticals Ireland Limited |
| Budenofalk 2mg/dose rectal foam | - | 18/05/17 | 13/01/20 | Budesonide | DR. FALK PHARMA GMBH |
| Budenofalk 3mg gastro-resistant capsules | - | 13/01/20 | 13/01/20 | Budesonide | DR. FALK PHARMA GMBH |
| Budenofalk 9mg gastro-resistant granules | - | 08/08/19 | 08/08/19 | Budesonide | DR. FALK PHARMA GMBH |
| Bufomix Easyhaler 160 micrograms/4.5 micrograms | - | 03/04/18 | 06/04/18 | Budesonide, Formoterol fumarate dihydrate | Orion Pharma (Ireland) Ltd |
| Bufomix Easyhaler 320 micrograms/9 micrograms | - | 03/04/18 | 06/04/18 | Budesonide, Formoterol fumarate dihydrate | Orion Pharma (Ireland) Ltd |
| Bufomix Easyhaler 80 micrograms/4.5 micrograms | - | 03/04/18 | 06/04/18 | Budesonide, Formoterol fumarate dihydrate | Orion Pharma (Ireland) Ltd |
| Burinex 1 mg Tablets | - | 03/04/19 | 09/07/19 | Bumetanide | Karo Pharma AB |
| Burinex 5 mg Tablets | - | 03/04/19 | 03/04/19 | Bumetanide | Karo Pharma AB |
| Buscopan 10 mg Coated Tablets | - | 24/10/18 | 18/12/17 | hyoscine butylbromide | SANOFI |
| Buscopan Ampoules | - | 11/11/19 | 16/10/19 | hyoscine butylbromide | SANOFI |
| Buscopan Rx 10mg Coated Tablets | - | 13/08/19 | 18/12/17 | hyoscine butylbromide | SANOFI |
| Busilvex 6 mg/ml concentrate for solution for infusion | - | 15/09/17 | 18/09/17 | Busulfan | Pierre Fabre Limited |
| BuTrans 15 microgram/hour transdermal patches | - | 11/02/19 | 11/02/19 | Buprenorphine | Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories |
| BuTrans transdermal patches | - | 24/01/19 | 24/01/19 | Buprenorphine | Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories |
| Buttercup Bronchostop Berry Flavour Cough Pastilles | - | 24/06/15 | 25/06/15 | Thyme herb extract | Chefaro Ireland Ltd |
| Buttercup Bronchostop Cough Syrup | - | 29/03/17 | 06/04/17 | Marshmallow root extract, Thyme herb extract | Chefaro Ireland Ltd |
| Bydureon 2 mg powder and solvent for prolonged-release suspension for injection in pre-filled pen | - | 02/05/19 | 11/04/19 | Exenatide | AstraZeneca Pharmaceuticals (Ireland) DAC |
| Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen | - | 02/05/19 | 12/04/19 | Exenatide | AstraZeneca Pharmaceuticals (Ireland) DAC |
| Cabaser 1mg Tablet | - | 28/02/18 | 01/03/18 | Cabergoline | Pfizer Healthcare Ireland |
| Cabaser 2mg Tablet | - | 28/02/18 | 01/03/18 | Cabergoline | Pfizer Healthcare Ireland |
| Cabometyx Tablets | | 05/11/19 | 11/11/19 | Cabozantinib | Ipsen Pharmaceuticals Ltd |
