| Brintellix 15 mg film-coated tablets | - |  03/07/19 |  03/07/19 | Vortioxetine hydrobromide | Lundbeck (Ireland) Limited |
| Brintellix 20 mg film-coated tablets | - | 03/07/19 | 03/07/19 | Vortioxetine hydrobromide | Lundbeck (Ireland) Limited |
| Brintellix 5 mg film-coated tablets | - | 03/07/19 | 03/07/19 | Vortioxetine hydrobromide | Lundbeck (Ireland) Limited |
| Brintellix 5mg, 10mg, 15mg, 20mg film-coated tablets | - | 04/12/18 | 03/07/19 | Vortioxetine hydrobromide | Lundbeck (Ireland) Limited |
| Briviact 10 mg/ml solution for injection/infusion | | 01/08/18 | 24/07/19 | Brivaracetam | UCB (Pharma) Ireland Limited |
| Briviact 10mg/ml oral solution | | 01/08/18 | 24/07/19 | Brivaracetam | UCB (Pharma) Ireland Limited |
| Briviact film-coated tablets | | 01/08/18 | 24/07/19 | Brivaracetam | UCB (Pharma) Ireland Limited |
| Brolene 0.1%w/v Eye Drops Solution | - | 08/08/19 | 07/05/14 | Propamidine Isethionate | SANOFI |
| Brolene 0.15% w/w Eye Ointment | - | 14/03/18 | 15/03/18 | Dibromopropamidine Isethionate | SANOFI |
| Bronchitol 40 mg, inhalation powder, hard capsules | - | 10/04/19 | 10/04/19 | Mannitol | Pharmaxis Europe Limited |
| Brufen 400mg film-coated Tablets | - | 17/01/19 | 14/06/19 | Ibuprofen | Mylan IRE Healthcare Limited |
| Brufen 600mg film-coated tablets | - | 17/01/19 | 14/06/19 | Ibuprofen | Mylan IRE Healthcare Limited |
| Brufen Paediatric 100mg/5ml Oral Suspension | - | 26/04/18 | 14/06/19 | Ibuprofen | Mylan IRE Healthcare Limited |
| Brufen Retard 800mg prolonged release tablets | - | 03/01/19 | 14/06/19 | 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 | 19/05/17 | Budesonide | DR. FALK PHARMA GMBH |
| Budenofalk 3mg gastro-resistant capsules | - | 11/03/19 | 11/03/19 | 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 |
