Helixate NexGen


octocog alfa

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Helixate NexGen. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Helixate NexGen.

For practical information about using Helixate NexGen, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 15/01/2018

Authorisation details

Product details
Helixate NexGen
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 Helixate NexGen - EMEA/H/C/000276 - A31/0178


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

Changes since initial authorisation of medicine

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