BeneFIX (nonacog alfa)
- Region
- 🇪🇺 EU
- Active substance
- nonacog alfa
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Hemophilia B
- EU approval
- Wed 27 Aug 1997
- Application
- EMEA/H/C/000139
- ATC
- B02BD04
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor-IX deficiency).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Idelvion Authorised · CSL Behring GmbH
- 🇪🇺 Alprolix Authorised · Swedish Orphan Biovitrum AB (publ)
- 🇪🇺 IXinity Application withdrawn · Cangene Europe Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.