| Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution PA1077/042/006 |
Beclometasone dipropionate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| BEKEMV 300 mg Concentrate for solution for infusion EU/1/23/1727/001 |
Eculizumab |
Amgen Technology (Ireland) Unlimited Company |
— |
| Bendamustine 100 mg powder for concentrate for solution for infusion PA2315/077/002 |
Bendamustine hydrochloride |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Bendamustine 25 mg powder for concentrate for solution for infusion PA2315/077/001 |
Bendamustine hydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| Bendamustine 25 mg/ml concentrate for solution for infusion PA2315/077/003 |
Bendamustine hydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| Bendroflumethiazide 2.5 mg Tablets PA22749/021/001 |
Bendroflumethiazide |
Brillpharma (Ireland) Limited |
Marketed |
| Bendroflumethiazide 5 mg Tablets PA22749/021/002 |
Bendroflumethiazide |
Brillpharma (Ireland) Limited |
Marketed |
| Benlysta 120 mg powder for concentrate for solution for infusion EU/1/11/700/001-002 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benlysta 200 mg solution for injection in pre-filled pen EU/1/11/700/003-005 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benlysta 200 mg solution for injection in pre-filled syringe EU/1/11/700/006-007 |
Belimumab |
GlaxoSmithKline (Ireland) Limited |
— |
| Benylin Children’s Chesty Cough 50 mg/5 ml Syrup PA23490/011/001 |
Guaifenesin |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Children’s Dry Coughs Syrup Diphenhydramine Hydrochloride 7 mg/5 ml Levomenthol 0.55 mg/5 ml PA23490/008/001 |
Levomenthol, Diphenhydramine hydrochloride |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Cough Medicine Syrup Diphenhydramine hydrochloride 14 mg/5 ml Levomenthol 1.1 mg/5 ml PA23490/005/001 |
Diphenhydramine hydrochloride, Levomenthol |
JNTL Consumer Health (Ireland) Limited |
Not marketed |
| BENYLIN Day & Night Tablets, 500mg/60mg tablets and 500/25mg film-coated tablets PA23490/006/001 |
Paracetamol, PSEUDOEPHEDRINE HYDROCHLORIDE, Paracetamol, Diphenhydramine hydrochloride |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Dry Coughs Syrup Diphenhydramine hydrochloride 14 mg/5 ml Dextromethorphan hydrobromide 6.5 mg/5 ml Levomenthol 2 mg/5 ml PA23490/004/001 |
Diphenhydramine hydrochloride, Dextromethorphan hydrobromide, Levomenthol |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Dual Action Dry Syrup, Pseudoephedrine 30mg, Dextromethorphan 10mg, Triprolidine 1.25mg PA23490/002/001 |
Dextromethorphan hydrobromide, PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg PA23490/013/001 |
Paracetamol, PSEUDOEPHEDRINE HYDROCHLORIDE, Diphenhydramine hydrochloride |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Herbal Chesty Coughs Syrup TR23490/001/001 |
|
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Benylin Mucus Cough Honey & Lemon 100mg/5ml Syrup PA23490/041/001 |
Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Benylin Mucus Cough Menthol 100 mg/5 ml oral solution PA23490/040/001 |
Guaifenesin |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Mucus Cough Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml PA23490/031/001 |
Levomenthol, Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Marketed |
| Benylin Mucus Relief 250 mg/5 ml Syrup PA23490/037/001 |
Carbocisteine |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Benylin Non-Drowsy Dry Coughs, Syrup Dextromethorphan hydrobromide 7.5 mg/5 ml PA23490/010/001 |
Dextromethorphan hydrobromide |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Non-drowsy for Chesty Coughs Syrup Guaifenesin 100 mg/5 ml Levomenthol 1.1 mg/5 ml PA23490/007/001 |
Levomenthol, Guaifenesin |
JNTL Consumer Health (Ireland) Limited |
Marketed |
| Benylin Phlegm Cough plus Decongestant SyrupGuaifenesin 100 mg/5 mlPseudoephedrine Hydrochloride 30 mg/5 ml PA23490/015/001 |
PSEUDOEPHEDRINE HYDROCHLORIDE, Guaifenesin |
JNTL Consumer Health I (Ireland) Limited |
Not marketed |
| Betacap Scalp Application 0.1 % w/w cutaneous solution PA23128/010/001 |
Betamethasone valerate |
Dermal Laboratories (Ireland) Limited |
Marketed |
| Betahistine dihydrochloride 16mg tablets PA2315/078/002 |
Betahistine dihydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| Betahistine dihydrochloride 8mg tablets PA2315/078/001 |
Betahistine dihydrochloride |
Accord Healthcare Ireland Ltd. |
Marketed |
| Betaloc 1 mg/ml solution for injection PA1404/007/001 |
METOPROLOL TARTRATE |
Recordati Ireland Limited |
Marketed |
| Betnovate Cream 0.1% w/w PA1077/001/001 |
Betamethasone |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Betnovate Ointment 0.1% w/w PA1077/001/002 |
Betamethasone valerate |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Betnovate Scalp Application 0.1% w/w Cutaneous Solution PA1077/001/003 |
Betamethasone |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Bicalutamide 50 mg film-coated tablets PA2315/079/001 |
Bicalutamide |
Accord Healthcare Ireland Ltd. |
Marketed |
| Biktarvy 30 mg/120 mg/15 mg Film-coated tablet EU/1/18/1289/005-006 |
Bictegravir Sodium, Emtricitabine, Tenofovir alafenamide fumarate |
Gilead Sciences Ireland UC |
— |
| Biktarvy 50 mg/200 mg/25 mg Film-coated tablet EU/1/18/1289/001-002 |
Bictegravir, Emtricitabine, Tenofovir alafenamide |
Gilead Sciences Ireland UC |
— |
| Bisoprolol 10 mg film-coated tablets PA2315/194/003 |
BISOPROLOL FUMARATE |
Accord Healthcare Ireland Ltd. |
Marketed |
| Bisoprolol 2.5 mg film-coated tablets PA2315/194/001 |
BISOPROLOL FUMARATE |
Accord Healthcare Ireland Ltd. |
Marketed |
| Bisoprolol 5 mg film-coated tablets PA2315/194/002 |
BISOPROLOL FUMARATE |
Accord Healthcare Ireland Ltd. |
Marketed |
| Bonjela Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010% PA0979/001/001 |
Choline salicylate, Cetalkonium chloride |
Reckitt Benckiser Ireland Limited |
Marketed |
| Bonjela Teething Gel Oromucosal Gel Choline Salicylate 8.714% Cetalkonium Chloride 0.010% PA0979/001/003 |
Choline salicylate, Cetalkonium chloride |
Reckitt Benckiser Ireland Limited |
Marketed |
| Boostrix suspension for injection in pre-filled syringe Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content) PA1077/020/001 |
Pertactin, Filamentous haemagglutinin, Pertussis toxoid, Tetanus toxoid, Diphtheria toxoid |
GlaxoSmithKline (Ireland) Limited |
Marketed |
| Bosentan Accord 125 mg film-coated tablets PA2315/286/002 |
Bosentan monohydrate |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Bosentan Accord 62.5 mg film-coated tablets PA2315/286/001 |
Bosentan monohydrate |
Accord Healthcare Ireland Ltd. |
Not marketed |
| Brillphalac 3.335 g/5 ml oral solution PA22749/011/001 |
Lactulose |
Brillpharma (Ireland) Limited |
Marketed |
| Brinzolamide 10 mg/ml eye drops, Suspension PA2315/149/001 |
Brinzolamide |
Accord Healthcare Ireland Ltd. |
Marketed |
| 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 |
— |