| Brineura 150 mg solution for infusion EU/1/17/1192/001 |
Cerliponase |
BioMarin International Limited |
— |
| Brinsupri 25 mg film-coated tablets EU/1/25/1995/001 |
Brensocatib monohydrate |
Insmed Netherlands B.V. |
— |
| Brintellix 10 mg film-coated tablets EU/1/13/891/008-017 |
Vortioxetine hydrobromide |
H. Lundbeck A/S |
— |
| Brintellix 15 mg film-coated tablets EU/1/13/891/018-026 |
Vortioxetine hydrobromide |
H. Lundbeck A/S |
— |
| Brintellix 20 mg film-coated tablets EU/1/13/891/027-035 |
Vortioxetine hydrobromide |
H. Lundbeck A/S |
— |
| Brintellix 20 mg/ml oral drops, solution EU/1/13/891/036 |
Vortioxetine-dl-lactate |
H. Lundbeck A/S |
— |
| Brintellix 5 mg film-coated tablets EU/1/13/891/001-007 |
Vortioxetine hydrobromide |
H. Lundbeck A/S |
— |
| Briumvi 150 mg Concentrate for solution for infusion EU/1/23/1730/001 |
Ublituximab |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Briviact 10 mg film-coated tablets EU/1/15/1073/001-004 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 10 mg/ml oral solution EU/1/15/1073/021 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 10 mg/ml solution for injection/infusion EU/1/15/1073/022 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 100 mg film-coated tablets EU/1/15/1073/017-020 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 25 mg film-coated tablets EU/1/15/1073/005-008 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 50 mg film-coated tablets EU/1/15/1073/009-012 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Briviact 75 mg film-coated tablets EU/1/15/1073/013-016 |
Brivaracetam |
UCB Pharma S.A. |
— |
| Bronchitol 40 mg inhalation powder, hard capsules EU/1/12/760/001-002 |
Mannitol |
Pharmaxis Europe Limited |
— |
| Bronx Airmaster 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed PA23030/001/001 |
Salmeterol, Fluticasone propionate |
Neutec Inhaler Ireland Limited |
— |
| Bronx Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed PA23030/001/002 |
Salmeterol, Fluticasone propionate |
Neutec Inhaler Ireland Limited |
— |
| Bronx Airmaster 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed PA23030/001/003 |
Salmeterol, Fluticasone propionate |
Neutec Inhaler Ireland Limited |
— |
| BRUKINSA 160 mg film-coated tablets EU/1/21/1576/002 |
Zanubrutinib |
BeiGene Ireland Limited |
— |
| BRUKINSA 80 mg hard capsules EU/1/21/1576/001 |
Zanubrutinib |
BeiGene Ireland Limited |
— |
| Brupro 200mg Film-coated tablets PA0074/067/001 |
Ibuprofen |
Rowa Pharmaceuticals Limited, |
Marketed |
| Brupro Cold & Flu 200 mg/30 mg film-coated tablets PA0074/067/006 |
Ibuprofen, PSEUDOEPHEDRINE HYDROCHLORIDE |
Rowa Pharmaceuticals Limited, |
Marketed |
| Brupro for Children 100 mg/5 ml oral suspension PA0074/067/004 |
Ibuprofen |
Rowa Pharmaceuticals Limited, |
Marketed |
| Brupro for Children Six Plus 200 mg/5 ml oral suspension PA0074/067/005 |
Ibuprofen |
Rowa Pharmaceuticals Limited, |
Marketed |
| Brupro Max 400mg Film-coated tablets PA0074/067/002 |
Ibuprofen |
Rowa Pharmaceuticals Limited |
Marketed |
| Brupro Rx 600mg Film-coated tablets PA0074/067/003 |
Ibuprofen |
Rowa Pharmaceuticals Limited |
Not marketed |
| BUCCOLAM 10 mg oromucosal solution EU/1/11/709/004 |
Midazolam |
Laboratorios Lesvi, S.L. |
— |
| BUCCOLAM 2.5 mg oromucosal solution EU/1/11/709/001 |
Midazolam |
Laboratorios Lesvi, S.L. |
— |
| BUCCOLAM 5 mg oromucosal solution EU/1/11/709/002 |
Midazolam |
Laboratorios Lesvi, S.L. |
— |
| BUCCOLAM 7.5 mg oromucosal solution EU/1/11/709/003 |
Midazolam |
Laboratorios Lesvi, S.L. |
— |
| Budesonide Azure 0.5 mg/2 ml Nebuliser Suspension PA22871/035/001 |
Budesonide |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Budesonide Azure 1 mg/2 ml Nebuliser Suspension PA22871/035/002 |
Budesonide |
Azure Pharmaceuticals Ltd. |
Not marketed |
| Bupivacaine Hydrochloride 0.25% w/v Solution for Injection PA0073/091/001 |
Bupivacaine hydrochloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Bupivacaine Hydrochloride 0.5% w/v Solution for Injection PA0073/091/002 |
Bupivacaine hydrochloride |
Mercury Pharmaceuticals (Ireland) Ltd |
Marketed |
| Buprenorphine 0.4 mg Sublingual Tablets PA1567/001/001 |
Buprenorphine hydrochloride |
Activase Pharmaceuticals Limited |
Not marketed |
| Buprenorphine 2 mg Sublingual Tablets PA1567/001/002 |
Buprenorphine hydrochloride |
Activase Pharmaceuticals Limited |
Not marketed |
| Buprenorphine 8 mg Sublingual Tablets PA1567/001/003 |
Buprenorphine hydrochloride |
Activase Pharmaceuticals Limited |
Not marketed |
| Buprenorphine Neuraxpharm EU/1/24/1809/001-003 |
Buprenorphine hydrochloride |
Laboratorios Lesvi, S.L. |
— |
| Buprenorphine Neuraxpharm EU/1/24/1809/004-006 |
Buprenorphine hydrochloride |
Laboratorios Lesvi, S.L. |
— |
| Buprenorphine Neuraxpharm EU/1/24/1809/007-009 |
Buprenorphine hydrochloride |
Laboratorios Lesvi, S.L. |
— |
| Buprenorphine Neuraxpharm EU/1/24/1809/010-012 |
Buprenorphine hydrochloride |
Laboratorios Lesvi, S.L. |
— |
| Busulfan Fresenius Kabi 6 mg/ml concentrate for solution for infusion EU/1/14/951/001 |
Busulfan |
Fresenius Kabi Deutschland GmbH |
— |
| BuTrans 10 micrograms/hour transdermal patch PA1688/002/002 |
Buprenorphine |
Mundipharma Pharmaceuticals Limited |
Marketed |
| BuTrans 15 microgram/hour transdermal patch PA1688/002/004 |
Buprenorphine |
Mundipharma Pharmaceuticals Limited |
Marketed |
| BuTrans 20 micrograms/hour transdermal patch PA1688/002/003 |
Buprenorphine |
Mundipharma Pharmaceuticals Limited |
Marketed |
| BuTrans 5 micrograms/hour transdermal patch PA1688/002/001 |
Buprenorphine |
Mundipharma Pharmaceuticals Limited |
Marketed |
| Buvidal 128 mg Prolonged-release solution for injection EU/1/18/1336/007 |
Buprenorphine |
Camurus AB |
— |
| Buvidal 16 mg Prolonged-release solution for injection EU/1/18/1336/002 |
Buprenorphine |
Camurus AB |
— |
| Buvidal 160 mg Prolonged-release solution for injection EU/1/18/1336/009 |
Buprenorphine |
Camurus AB |
— |