BeneFIX Pfizer Europe MA EEIG · Authorised · authorised 27 Aug 1997 · ATC B02BD04
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).
Active substance
Nonacog alfa
- EMA 1
- UK MHRA 5
EMA European Union — centrally authorised medicines
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| BENEFIX 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00057/1540 | PFIZER LIMITED | POM |
| BENEFIX 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00057/1542 | PFIZER LIMITED | POM |
| BENEFIX 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00057/1543 | PFIZER LIMITED | POM |
| BENEFIX 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00057/1544 | PFIZER LIMITED | POM |
| BENEFIX 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PLGB 00057/1545 | PFIZER LIMITED | POM |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.