Kogenate Bayer

Lapsed

This medicine's authorisation has lapsed

octocog alfa

Overview

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.

Kogenate Bayer : EPAR - Summary for the public

Product information

Kogenate Bayer : EPAR - Product information

Latest procedure affecting product information: A31/0185

16/11/2017

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

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

  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

AdoptedReference Number: EMA/763977/2017

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

AdoptedReference 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

AdoptedReference 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