Helixate NexGen : EPAR - Summary for the public (PDF/674.79 KB)
First published: 12/05/2009
Last updated: 02/06/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
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.
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.
Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes15/09/2017
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 December 201320/12/2013
PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients06/12/2013