| Brinzolamide 10 mg/ml eye drops, Suspension PA2315/149/001 |
Brinzolamide |
Accord Healthcare Ireland Ltd. |
Marketed |
| Brinzolamide Rowex 10 mg/ml eye drops, suspension PA0711/343/001 |
Brinzolamide |
Rowex Limited, |
Not marketed |
| Brinzolamide Sandoz 10mg/ml eye drops, suspension PA0711/226/001 |
Brinzolamide |
Rowex Ltd |
Marketed |
| Briumvi 150 mg Concentrate for solution for infusion EU/1/23/1730/001 |
Ublituximab |
Neuraxpharm Pharmaceuticals S.L. |
— |
| Brivaracetam Clonmel 10 mg film-coated tablets PA0126/403/001 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 100 mg film-coated tablets PA0126/403/005 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 25 mg film-coated tablets PA0126/403/002 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 50 mg film-coated tablets PA0126/403/003 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| Brivaracetam Clonmel 75 mg film-coated tablets PA0126/403/004 |
Brivaracetam |
Clonmel Healthcare Ltd |
Not marketed |
| 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. |
— |
| Brodilaten 1.25 mg/2.5 ml Nebuliser solution PA1122/024/001 |
Salbutamol |
Noridem Enterprises Limited |
Not marketed |
| Brodilaten 2.5 mg/2.5 ml nebuliser solution PA1122/024/002 |
Salbutamol |
Noridem Enterprises Limited |
Not marketed |
| Brodilaten 5.0 mg/2.5 ml Nebuliser solution PA1122/024/003 |
Salbutamol |
Noridem Enterprises Limited |
Not marketed |
| Brolene 0.1% w/v Eye Drops Solution PA0126/357/001 |
Propamidine isetionate |
Clonmel Healthcare Ltd |
Marketed |
| Brolene 0.15 % w/w Eye Ointment PA0126/357/002 |
Dibrompropamidine isetionate |
Clonmel Healthcare Ltd |
Marketed |
| Bronchitol 40 mg inhalation powder, hard capsules EU/1/12/760/001-002 |
Mannitol |
Pharmaxis Europe Limited |
— |
| Bronchoforce chesty cough oral drops TR2309/010/001 |
|
A.Vogel Ireland Limited |
Marketed |
| Bronchosan dry, tickly cough syrup TR2309/008/001 |
|
A.Vogel Ireland Limited |
Marketed |
| 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 |
— |
| Brufen 400mg film-coated tablets PA23355/012/001 |
Ibuprofen |
Viatris Healthcare Limited |
Marketed |
| Brufen 600mg film-coated tablets PA23355/012/002 |
Ibuprofen |
Viatris Healthcare Limited |
Marketed |
| Brufen Paediatric 100 mg/5 ml Oral Suspension PA23355/012/003 |
Ibuprofen |
Viatris Healthcare Limited |
Marketed |
| Brufen Retard 800mg prolonged release tablets PA23355/012/004 |
Ibuprofen |
Viatris Healthcare Limited |
Marketed |
| 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 |
| Bryonia HOR1149/007/001 |
Bryonia cretica |
A. Nelson & Company 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. |
— |
| Budenofalk 2mg/dose rectal foam PA0573/002/002 |
Budesonide |
Dr. Falk Pharma GmbH |
Marketed |
| Budenofalk 3 mg gastro-resistant capsules PA0573/002/001 |
Budesonide |
Dr. Falk Pharma GmbH |
Marketed |
| Budenofalk 4 mg suppositories PA0573/008/001 |
Budesonide |
Dr. Falk Pharma GmbH |
Not marketed |
| Budenofalk® 9mg gastro-resistant granules PA0573/002/003 |
Budesonide |
Dr. Falk Pharma GmbH |
Marketed |
| 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 |