Kogenate Bayer


octocog alfa

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Kogenate Bayer has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 02/03/2023

Authorisation details

Product details
Kogenate Bayer
Agency product number
Active substance
octocog alfa
International non-proprietary name (INN) or common name
octocog alfa
Therapeutic area (MeSH)
Hemophilia A
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Bayer AG 
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Bayer AG
51368 Leverkusen

Product information

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

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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 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

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