Helixate NexGen

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Withdrawn

This medicine's authorisation has been withdrawn

octocog alfa
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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Public Assessment Report (EPAR) for Helixate NexGen (SRD) is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: A31/0178
16/11/2017
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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).

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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 

Bayer AG
51368 Leverkusen
Germany

Marketing authorisation issued
04/08/2000
Revision
31

Assessment history

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