Obizur Baxalta Innovations GmbH · Authorised · authorised 11 Nov 2015 · ATC B02
Therapeutic indication (EMA)
Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.
Active substance
Susoctocog alfa
- EMA 1
- Safety 1
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- EMA PRAC 8 Feb 2018 PRAC signal: Inhibitor development in previously untreated patients (PUPs) with haemophilia A treated with plasma-derived vs recombinant coagulation factor VIII concentrates
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.