Helixate NexGen
Withdrawn
This medicine's authorisation has been withdrawn
octocog alfa
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Helixate NexGen has been withdrawn at the request of the marketing-authorisation holder.
Helixate NexGen : EPAR - Summary for the public
English (EN) (674.79 KB - PDF)
First published: Last updated:
български (BG) (768.2 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
español (ES) (672.9 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
čeština (CS) (728.75 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
dansk (DA) (652.35 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
Deutsch (DE) (652.26 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
eesti keel (ET) (670.26 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
ελληνικά (EL) (773.88 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
français (FR) (652.41 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
italiano (IT) (671.13 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
latviešu valoda (LV) (735.33 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
lietuvių kalba (LT) (701.69 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
magyar (HU) (744.98 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
Malti (MT) (772.61 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
Nederlands (NL) (672.62 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
polski (PL) (729.14 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
português (PT) (649.2 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
română (RO) (701.16 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
slovenčina (SK) (751.06 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
slovenščina (SL) (741.26 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
Suomi (FI) (670.86 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
svenska (SV) (673.15 KB - PDF)
First published: 12/05/2009Last updated: 02/06/2020
Product information
Helixate NexGen : EPAR - Product information
English (EN) (934.15 KB - PDF)
First published: Last updated:
български (BG) (2.17 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
español (ES) (1.17 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
čeština (CS) (1.86 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
dansk (DA) (1.12 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
Deutsch (DE) (1.17 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
eesti keel (ET) (1.14 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
ελληνικά (EL) (2.21 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
français (FR) (1.21 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
hrvatski (HR) (1.23 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
íslenska (IS) (1.01 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
italiano (IT) (1.18 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
latviešu valoda (LV) (1.92 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
lietuvių kalba (LT) (1.23 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
magyar (HU) (1.57 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
Malti (MT) (1.95 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
Nederlands (NL) (1.19 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
norsk (NO) (1 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
polski (PL) (1.93 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
português (PT) (1.16 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
română (RO) (1.24 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
slovenčina (SK) (1.88 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
slovenščina (SL) (1.79 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
Suomi (FI) (1.16 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
svenska (SV) (1.18 MB - PDF)
First published: 12/11/2009Last updated: 02/06/2020
Latest procedure affecting product information:
A31/0178
16/11/2017
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).
Helixate NexGen : EPAR - All authorised presentations
English (EN) (584.47 KB - PDF)
First published: Last updated:
български (BG) (625.66 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
español (ES) (580.81 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
čeština (CS) (611.81 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
dansk (DA) (580.7 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
Deutsch (DE) (580.46 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
eesti keel (ET) (580.66 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
ελληνικά (EL) (631.23 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
français (FR) (580.57 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
hrvatski (HR) (595.81 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
íslenska (IS) (580.52 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
italiano (IT) (580.46 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
latviešu valoda (LV) (614.96 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
lietuvių kalba (LT) (590.15 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
magyar (HU) (610.4 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
Malti (MT) (614.17 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
Nederlands (NL) (585.56 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
norsk (NO) (580.65 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
polski (PL) (612.89 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
português (PT) (581.98 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
română (RO) (596.88 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
slovenčina (SK) (611.6 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
slovenščina (SL) (596.06 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
Suomi (FI) (580.75 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
svenska (SV) (584.26 KB - PDF)
First published: 21/01/2008Last updated: 02/06/2020
Product details
- Name of medicine
- Helixate NexGen
- 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
Pharmacotherapeutic group
AntihemorrhagicsTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/000276
- Marketing authorisation holder
- Bayer AG
Bayer AG
51368 Leverkusen
Germany - Marketing authorisation issued
- 04/08/2000
- Revision
- 31
Assessment history
Helixate NexGen : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (986.42 KB - PDF)
First published: Last updated:
Helixate NexGen-H-C-0276-A31-0178 : EPAR - Assessment Report - Article 31
AdoptedReference Number: EMA/763977/2017
English (EN) (905.6 KB - PDF)
First published: Last updated:
Helixate NexGen-H-C-A20-143 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (651.08 KB - PDF)
First published: Last updated:
български (BG) (844.19 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
español (ES) (658.41 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
čeština (CS) (802.29 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
dansk (DA) (655.05 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
Deutsch (DE) (665.36 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
eesti keel (ET) (654.65 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
ελληνικά (EL) (867.86 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
français (FR) (655.34 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
hrvatski (HR) (699.51 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
italiano (IT) (655.65 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
latviešu valoda (LV) (811.59 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
lietuvių kalba (LT) (699.72 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
magyar (HU) (787.75 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
Malti (MT) (789.62 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
Nederlands (NL) (656.85 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
polski (PL) (802.69 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
português (PT) (663.08 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
română (RO) (707.66 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
slovenčina (SK) (824.85 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
slovenščina (SL) (788.52 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
Suomi (FI) (658.67 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
svenska (SV) (663.08 KB - PDF)
First published: 20/03/2014Last updated: 02/06/2020
Helixate NexGen-H-C-276-A20-143 : EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/10430/2014
English (EN) (798.1 KB - PDF)
First published: Last updated:
Helixate NexGen-H-C-276-WS-193 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/282360/2012
English (EN) (1.3 MB - PDF)
First published: Last updated:
Helixate NexGen : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (660.51 KB - PDF)
First published: Last updated:
News on Helixate NexGen
More information on Helixate NexGen
Public statement on Helixate NexGen: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/171441/2020
English (EN) (109.45 KB - PDF)
First published:
Questions and answers on the outcome of extension of indication application for Kogenate Bayer and Helixate Nexgen (octocog alfa)
English (EN) (610.22 KB - PDF)
First published: Last updated:
More information on Helixate NexGen
Topics
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