Kogenate Bayer

Lapsed

This medicine's authorisation has lapsed

octocog alfa

Overview

On 31 December 2022, the marketing authorisation of Kogenate Bayer (octocog alfa) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Bayer AG, permanently discontinued marketing of Kogenate Bayer in the European Union (EU) in December 2019. In accordance with provisions of the sunset clause1, the marketing authorisation of a medicinal product lapses if the product had not been marketed in any EU Member States for three consecutive years. 

Bayer AG confirmed that it discontinued the marketing of the product because it no longer intends to market or retain the marketing authorisation for this medicinal product. KOGENATE Bayer was granted marketing authorisation in the EU on 4 August 2000 for the treatment of haemophilia A. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2005. It was then granted unlimited validity in 2010. 

The European Public Assessment Report (EPAR) for Kogenate Bayer is updated to indicate that the marketing authorisation is no longer valid.

Kogenate Bayer : EPAR - Summary for the public

Product information

Kogenate Bayer : EPAR - Product information

Kogenate Bayer : EPAR - All authorised presentations

Product details

• Name of medicine:
  Kogenate Bayer
• 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

Pharmacotherapeutic group

Antihemorrhagics

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000275
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen; Germany

• Marketing authorisation issued:
  04/08/2000
• Lapse of marketing authorisation:
  31/12/2022
• Revision:
  30

Assessment history

Changes since initial authorisation of medicine

Kogenate Bayer : EPAR - Procedural steps taken and scientific information after authorisation

Kogenate Bayer-H-C-0275-A31-0185 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/763977/2017

Kogenate Bayer-H-C-275-A20-150 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/10430/2014

Kogenate Bayer-H-C-275-A20-150 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Kogenate Bayer-H-C-275-WS-193 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/282360/2012

Kogenate Bayer : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Kogenate Bayer : EPAR - Procedural steps taken before authorisation

Kogenate Bayer : EPAR - Scientific Discussion