Adynovi (rurioctocog alfa pegol)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rurioctocog alfa pegol
- Company
- Baxalta Innovations GmbH
- Status
- Authorised
- Therapeutic area
- Hemophilia A
- EU approval
- Mon 08 Jan 2018
- Designations
- Additional monitoring
- Application
- EMEA/H/C/004195
- ATC
- B02BD02
- Official record
- www.ema.europa.eu
Indication
Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Regulatory milestones
No milestones recorded in the last year.
Follow Adynovi
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.