Obizur (susoctocog alfa)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- susoctocog alfa
- Company
- Baxalta Innovations GmbH
- Status
- Authorised
- Therapeutic area
- Hemophilia A
- EU approval
- Wed 11 Nov 2015
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/002792
- ATC
- B02
- Official record
- www.ema.europa.eu
Indication
Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.
Regulatory milestones
No milestones recorded in the last year.
Follow Obizur
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.