| BeneFIX 1000 IU powder and solvent for solution for injection EU/1/97/047/006 |
Nonacog alfa |
Pfizer Europe MA EEIG |
— |
| BeneFIX 1500 IU powder and solvent for solution for injection EU/1/97/047/009 |
Nonacog alfa |
Pfizer Europe MA EEIG |
— |
| BeneFIX 2000 IU powder and solvent for solution for injection EU/1/97/047/007 |
Nonacog alfa |
Pfizer Europe MA EEIG |
— |
| BeneFIX 250 IU powder and solvent for solution for injection EU/1/97/047/004 |
Nonacog alfa |
Pfizer Europe MA EEIG |
— |
| BeneFIX 3000 IU powder and solvent for solution for injection EU/1/97/047/008 |
Nonacog alfa |
Pfizer Europe MA EEIG |
— |
| BeneFIX 500 IU powder and solvent for solution for injection EU/1/97/047/005 |
Nonacog alfa |
Pfizer Europe MA EEIG |
— |
| Benepali 25 mg solution for injection in pre-filled syringe EU/1/15/1074/005-007 |
Etanercept |
Samsung Bioepis NL B.V. |
— |
| Benepali 50 mg solution for injection in pre-filled pen EU/1/15/1074/002 |
Etanercept |
Samsung Bioepis NL B.V. |
— |
| Benepali 50 mg solution for injection in pre-filled syringe EU/1/15/1074/001 |
Etanercept |
Samsung Bioepis NL B.V. |
— |
| 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 |
| Benzyl Benzoate 25% w/v Application Cutaneous Emulsion PA0206/023/001 |
Benzyl benzoate |
Ovelle Limited |
Marketed |
| Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion PA2059/085/002 |
Benzylpenicillin Sodium |
Fresenius Kabi Deutschland GmbH |
Not marketed |
| Benzylpenicillin sodium 1200 mg powder for solution for injection/infusion PA1122/038/002 |
Benzylpenicillin Sodium |
Noridem Enterprises Limited |
Not marketed |
| Benzylpenicillin sodium 3000 mg powder for solution for injection/infusion PA1122/038/003 |
Benzylpenicillin Sodium |
Noridem Enterprises Limited |
Not marketed |
| Benzylpenicillin sodium 3000 mg Powder for Solution for Injection/Infusion PA0711/310/002 |
Benzylpenicillin |
Rowex Ltd |
Not marketed |
| Benzylpenicillin sodium 600 mg powder for solution for injection/infusion PA2059/085/001 |
Benzylpenicillin Sodium |
Fresenius Kabi Deutschland GmbH |
Marketed |
| Benzylpenicillin sodium 600 mg powder for solution for injection/infusion PA1122/038/001 |
Benzylpenicillin Sodium |
Noridem Enterprises Limited |
Not marketed |
| Benzylpenicillin sodium 600 mg Powder for Solution for Injection/Infusion PA0711/310/001 |
Benzylpenicillin |
Rowex Ltd |
Not marketed |
| Benzylpenicillin sodium 6000 mg powder for solution for injection/infusion PA1122/038/004 |
Benzylpenicillin Sodium |
Noridem Enterprises Limited |
Not marketed |
| Beovu 120 mg/ml solution for injection in pre-filled syringe EU/1/19/1417/001-002 |
Brolucizumab |
Novartis Europharm Limited |
— |
| Bepantiseptic First Aid Cream PA1410/047/001 |
Phenol, Chlorhexidine digluconate |
Bayer Limited |
Marketed |
| Berinert 1500 IU Powder and solvent for solution for injection PA0800/013/002 |
C1 Esterase Inhibitor (Human) |
CSL Behring GmbH |
Not marketed |
| Berinert 2000 IU Powder and solvent for solution for injection PA0800/013/003 |
C1 Esterase Inhibitor (Human) |
CSL Behring GmbH |
Not marketed |
| Berinert 3000 IU Powder and solvent for solution for injection PA0800/013/004 |
C1 Esterase Inhibitor (Human) |
CSL Behring GmbH |
Not marketed |
| Berinert 500 IU Powder and solvent for solution for injection/infusion. PA0800/013/001 |
C1 Esterase Inhibitor (Human) |
CSL Behring GmbH |
Marketed |
| Beriplex P/N 1000 IU, powder and solvent for solution for injection PA0800/010/003 |
Factor ii activity, Factor vii activity, Factor x activity, Factor ix activity, Protein c activity |
CSL Behring GmbH |
Not marketed |
| Beriplex P/N 250 IU, powder and solvent for solution for injection PA0800/010/001 |
Factor ii activity, Factor vii activity, Factor x activity, Factor ix activity, Protein c activity |
CSL Behring GmbH |
Not marketed |
| Beriplex P/N 500 IU, powder and solvent for solution for injection PA0800/010/002 |
Factor ii activity, Factor vii activity, Factor x activity, Factor ix activity, Protein c activity |
CSL Behring GmbH |
Marketed |
| Beromun 1 mg powder for solution for infusion EU/1/99/097/001 |
Tumour necrosis factor alfa 1a |
Belpharma S.A. |
— |
| BESPONSA 1 mg powder for concentrate for solution for infusion EU/1/17/1200/001 |
Inotuzumab ozogamicin |
Pfizer Europe MA EEIG |
— |
| Besremi 250 micogram/0.5 ml Solution for injection in pre-filled pen EU/1/18/1352/001 |
Ropeginterferon alfa-2b |
Aop Orphan Pharmaceuticals GmbH |
— |
| Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen EU/1/18/1352/002 |
Ropeginterferon alfa-2b |
Aop Orphan Pharmaceuticals GmbH |
— |
| Beta-Prograne 160mg Prolonged-Release Capsules PA22720/002/001 |
Propranolol hydrochloride |
Tillomed Pharma GmbH |
Marketed |