susoctocog alfa

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Obizur. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Obizur.

For practical information about using Obizur, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 26/10/2022

Authorisation details

Product details
Agency product number
Active substance
susoctocog alfa
International non-proprietary name (INN) or common name
susoctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Publication details
Marketing-authorisation holder
Baxalta Innovations GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Industriestrasse 67
A-1221 Vienna

Product information

20/06/2022 Obizur - EMEA/H/C/002792 - S/0044

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.

Assessment history

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