Obizur

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susoctocog alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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 10/07/2017

Authorisation details

Product details
Name
Obizur
Agency product number
EMEA/H/C/002792
Active substance
susoctocog alfa
International non-proprietary name (INN) or common name
susoctocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02
Additional 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 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
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
11/11/2015
Contact address
Industriestrasse 67
A-1221 Vienna
Austria

Product information

01/06/2017 Obizur - EMEA/H/C/002792 - N/0012

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

ANTIHEMORRHAGICS
 

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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