Helixate NexGen
octocog alfa
Table of contents
Overview
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.
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
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
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.