Helixate NexGen
octocog alfa
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Helixate NexGen has been withdrawn at the request of the marketing-authorisation holder.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 | |
Product information
16/11/2017 Helixate NexGen - EMEA/H/C/000276 - A31/0178
Contents
- 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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antihemorrhagics
Therapeutic indication
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.