Kovaltry

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octocog 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 Kovaltry. 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 Kovaltry.

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

This EPAR was last updated on 08/10/2018

Authorisation details

Product details
Name
Kovaltry
Agency product number
EMEA/H/C/003825
Active substance
octocog alfa
International non-proprietary name (INN) or common name
octocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
B02BD02
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.

Publication details
Marketing-authorisation holder
Bayer Pharma AG
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
18/02/2016
Contact address

Muellerstrasse 178
13353 Berlin
Germany

Product information

14/09/2018 Kovaltry - EMEA/H/C/003825 - IA/0018

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 and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.

Assessment history

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