Kogenate Bayer

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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 Kogenate Bayer. 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 Kogenate Bayer.

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

This EPAR was last updated on 04/05/2018

Authorisation details

Product details
Name
Kogenate Bayer
Agency product number
EMEA/H/C/000275
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
Publication details
Marketing-authorisation holder
Bayer AG 
Revision
30
Date of issue of marketing authorisation valid throughout the European Union
04/08/2000
Contact address
Bayer AG
51368 Leverkusen
Germany

Product information

16/11/2017 Kogenate Bayer - EMEA/H/C/000275 - A31/0185

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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

Antihaemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

Assessment history

Changes since initial authorisation of medicine

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