ReFacto AF (moroctocog alfa)
- Region
- 🇪🇺 EU
- Active substance
- moroctocog alfa
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Hemophilia A
- EU approval
- Tue 13 Apr 1999
- Application
- EMEA/H/C/000232
- ATC
- B02BD02
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Elocta Authorised · Swedish Orphan Biovitrum AB (publ)
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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.