Afstyla (lonoctocog alfa)
- Region
- 🇪🇺 EU
- Active substance
- lonoctocog alfa
- Company
- CSL Behring GmbH
- Status
- Authorised
- Therapeutic area
- Hemophilia A
- CHMP opinion
- Thu 10 Nov 2016
- EU approval
- Wed 04 Jan 2017
- Application
- EMEA/H/C/004075
- ATC
- B02BD02
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Afstyla can be used for all age groups.
Regulatory milestones
No milestones recorded in the last year.
Follow Afstyla
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.