Nonafact Sanquin Plasma Products B.V. · Withdrawn · authorised 3 Jul 2001 · ATC B02BD04
Therapeutic indication (EMA)
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Active substance
Human coagulation factor ix
- EMA 1
- UK MHRA 5
EMA European Union — centrally authorised medicines
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| ALPHANINE 1000 I.U. POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PL 12930/0013 | INSTITUTO GRIFOLS S.A. | POM |
| ALPHANINE 1500 I.U. POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PL 12930/0014 | INSTITUTO GRIFOLS S.A. | POM |
| ALPHANINE 500 I.U. POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PL 12930/0012 | INSTITUTO GRIFOLS S.A. | POM |
| HAEMONINE 1000 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PL 04500/0008 | BIOTEST PHARMA GMBH | POM |
| HAEMONINE 500 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | PL 04500/0008 | BIOTEST PHARMA GMBH | 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.