Helixate NexGen

octocog alfa

Table of contents

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Helixate NexGen has been withdrawn at the request of the marketing-authorisation holder.

List item

Helixate NexGen : EPAR - Summary for the public (PDF/674.79 KB)

First published: 12/05/2009
Last updated: 02/06/2020
- Bulgarian
  (PDF/768.2 KB)
- Czech
  (PDF/728.75 KB)
- Danish
  (PDF/652.35 KB)
- Dutch
  (PDF/672.62 KB)
- Estonian
  (PDF/670.26 KB)
- Finnish
  (PDF/670.86 KB)
- French
  (PDF/652.41 KB)
- German
  (PDF/652.26 KB)
- Greek
  (PDF/773.88 KB)
- Hungarian
  (PDF/744.98 KB)
- Italian
  (PDF/671.13 KB)
- Latvian
  (PDF/735.33 KB)
- Lithuanian
  (PDF/701.69 KB)
- Maltese
  (PDF/772.61 KB)
- Polish
  (PDF/729.14 KB)
- Portuguese
  (PDF/649.2 KB)
- Romanian
  (PDF/701.16 KB)
- Slovak
  (PDF/751.06 KB)
- Slovenian
  (PDF/741.26 KB)
- Spanish
  (PDF/672.9 KB)
- Swedish
  (PDF/673.15 KB)

More detail is available in the summary of product characteristics

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

List item

Helixate NexGen : EPAR - Product information (PDF/934.15 KB)

First published: 12/11/2009
Last updated: 02/06/2020
- Bulgarian
  (PDF/2.17 MB)
- Croatian
  (PDF/1.23 MB)
- Czech
  (PDF/1.86 MB)
- Danish
  (PDF/1.12 MB)
- Dutch
  (PDF/1.19 MB)
- Estonian
  (PDF/1.14 MB)
- Finnish
  (PDF/1.16 MB)
- French
  (PDF/1.21 MB)
- German
  (PDF/1.17 MB)
- Greek
  (PDF/2.21 MB)
- Hungarian
  (PDF/1.57 MB)
- Icelandic
  (PDF/1.01 MB)
- Italian
  (PDF/1.18 MB)
- Latvian
  (PDF/1.92 MB)
- Lithuanian
  (PDF/1.23 MB)
- Maltese
  (PDF/1.95 MB)
- Norwegian
  (PDF/1 MB)
- Polish
  (PDF/1.93 MB)
- Portuguese
  (PDF/1.16 MB)
- Romanian
  (PDF/1.24 MB)
- Slovak
  (PDF/1.88 MB)
- Slovenian
  (PDF/1.79 MB)
- Spanish
  (PDF/1.17 MB)
- Swedish
  (PDF/1.18 MB)

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.

List item

Helixate NexGen : EPAR - All authorised presentations (PDF/584.47 KB)

First published: 21/01/2008
Last updated: 02/06/2020
- Bulgarian
  (PDF/625.66 KB)
- Croatian
  (PDF/595.81 KB)
- Czech
  (PDF/611.81 KB)
- Danish
  (PDF/580.7 KB)
- Dutch
  (PDF/585.56 KB)
- Estonian
  (PDF/580.66 KB)
- Finnish
  (PDF/580.75 KB)
- French
  (PDF/580.57 KB)
- German
  (PDF/580.46 KB)
- Greek
  (PDF/631.23 KB)
- Hungarian
  (PDF/610.4 KB)
- Icelandic
  (PDF/580.52 KB)
- Italian
  (PDF/580.46 KB)
- Latvian
  (PDF/614.96 KB)
- Lithuanian
  (PDF/590.15 KB)
- Maltese
  (PDF/614.17 KB)
- Norwegian
  (PDF/580.65 KB)
- Polish
  (PDF/612.89 KB)
- Portuguese
  (PDF/581.98 KB)
- Romanian
  (PDF/596.88 KB)
- Slovak
  (PDF/611.6 KB)
- Slovenian
  (PDF/596.06 KB)
- Spanish
  (PDF/580.81 KB)
- Swedish
  (PDF/584.26 KB)

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

List item

Helixate NexGen : EPAR - Procedural steps taken and scientific information after authorisation (PDF/986.42 KB)

First published: 12/11/2009
Last updated: 02/06/2020
List item

Helixate NexGen-H-C-0276-A31-0178 : EPAR - Assessment Report - Article 31 (PDF/905.6 KB)

Adopted

First published: 05/12/2017
Last updated: 02/06/2020
EMA/763977/2017
List item

Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/651.08 KB)

First published: 20/03/2014
Last updated: 02/06/2020
- Bulgarian
  (PDF/844.19 KB)
- Croatian
  (PDF/699.51 KB)
- Czech
  (PDF/802.29 KB)
- Danish
  (PDF/655.05 KB)
- Dutch
  (PDF/656.85 KB)
- Estonian
  (PDF/654.65 KB)
- Finnish
  (PDF/658.67 KB)
- French
  (PDF/655.34 KB)
- German
  (PDF/665.36 KB)
- Greek
  (PDF/867.86 KB)
- Hungarian
  (PDF/787.75 KB)
- Italian
  (PDF/655.65 KB)
- Latvian
  (PDF/811.59 KB)
- Lithuanian
  (PDF/699.72 KB)
- Maltese
  (PDF/789.62 KB)
- Polish
  (PDF/802.69 KB)
- Portuguese
  (PDF/663.08 KB)
- Romanian
  (PDF/707.66 KB)
- Slovak
  (PDF/824.85 KB)
- Slovenian
  (PDF/788.52 KB)
- Spanish
  (PDF/658.41 KB)
- Swedish
  (PDF/663.08 KB)
List item

Helixate NexGen-H-C-276-A20-143 : EPAR - Assessment Report - Article 20 (PDF/798.1 KB)

Adopted

First published: 20/03/2014
Last updated: 02/06/2020
EMA/10430/2014
List item

Helixate NexGen-H-C-276-WS-193 : EPAR - Assessment Report - Variation (PDF/1.3 MB)

Adopted

First published: 21/05/2012
Last updated: 02/06/2020
EMA/282360/2012
List item

Helixate NexGen : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/660.51 KB)

First published: 06/11/2006
Last updated: 02/06/2020

Initial marketing-authorisation documents

News

Related content

Factor VIII: Article 31 referrals