Helixate NexGen

Withdrawn

This medicine's authorisation has been withdrawn

octocog alfa

Overview

On 16 December 2019, the European Commission withdrew the marketing authorisation for Helixate NexGen (SRD) (octocog alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Helixate NexGen (SRD) was granted marketing authorisation in the EU on 4 August 2000 for 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 2010. It was then granted unlimited validity in 2010. The product had not been marketed in the EU since 2019. Helixate NexGen (SRD) is an identical product to Kogenate Bayer. The marketing authorisation holder will maintain the marketing authorisation for Kogenate Bayer. 

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Public Assessment Report (EPAR) for Helixate NexGen (SRD) is updated to indicate that the marketing authorisation is no longer valid.

Helixate NexGen : EPAR - Summary for the public

Product information

Helixate NexGen : EPAR - Product information

Helixate NexGen : EPAR - All authorised presentations

Product details

• Name of medicine:
  Helixate NexGen
• 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/000276
• Marketing authorisation holder:
  Bayer AG

  51368 Leverkusen; Germany

• Marketing authorisation issued:
  04/08/2000
• Revision:
  31

Assessment history

Changes since initial authorisation of medicine

Helixate NexGen : EPAR - Procedural steps taken and scientific information after authorisation

Helixate NexGen-H-C-0276-A31-0178 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/763977/2017

Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Helixate NexGen-H-C-276-A20-143 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/10430/2014

Helixate NexGen-H-C-276-WS-193 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/282360/2012

Helixate NexGen : EPAR - Steps taken after authorisation when a cutoff date has been used

Initial marketing authorisation documents

Helixate NexGen : EPAR - Scientific Discussion

Helixate NexGen : EPAR - Procedural steps taken before authorisation