Refixia (nonacog beta pegol)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- nonacog beta pegol
- Company
- Novo Nordisk A/S
- Status
- Authorised
- Therapeutic area
- Hemophilia B
- CHMP opinion
- Thu 23 Mar 2017
- EU approval
- Fri 02 Jun 2017
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004178
- ATC
- B02BD04
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). Refixia can be used for all age groups.
Regulatory milestones
No milestones recorded in the last year.
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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.