Helixate NexGen

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octocog alfa

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Helixate NexGen has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 02/06/2020

Authorisation details

Product details
Name
Helixate NexGen
Agency product number
EMEA/H/C/000276
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
Publication details
Marketing-authorisation holder
Bayer AG 
Revision
31
Date of issue of marketing authorisation valid throughout the European Union
04/08/2000
Contact address

Bayer AG
51368 Leverkusen
Germany

Product information

16/11/2017 Helixate NexGen - EMEA/H/C/000276 - A31/0178

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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