Helixate NexGen
octocog alfa
Table of contents
Overview
The marketing authorisation for Helixate NexGen has been withdrawn at the request of the marketing-authorisation holder.
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 |
Product information
16/11/2017 Helixate NexGen - EMEA/H/C/000276 - A31/0178
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.