- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 16 December 2019, the European Commission withdrew the marketing authorisation for Helixate NexGen (SRD) (octocog alfa) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bayer AG, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Helixate NexGen (SRD) was granted marketing authorisation in the EU on 4 August 2000 for treatment of haemophilia A. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2010. It was then granted unlimited validity in 2010. The product had not been marketed in the EU since 2019. Helixate NexGen (SRD) is an identical product to Kogenate Bayer. The marketing authorisation holder will maintain the marketing authorisation for Kogenate Bayer.
The European Public Assessment Report (EPAR) for Helixate NexGen (SRD) is updated to indicate that the marketing authorisation is no longer valid.
Helixate NexGen : EPAR - Summary for the public
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latviešu valoda (LV) (735.33 KB - PDF)
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magyar (HU) (744.98 KB - PDF)
Malti (MT) (772.61 KB - PDF)
Nederlands (NL) (672.62 KB - PDF)
polski (PL) (729.14 KB - PDF)
português (PT) (649.2 KB - PDF)
română (RO) (701.16 KB - PDF)
slovenčina (SK) (751.06 KB - PDF)
slovenščina (SL) (741.26 KB - PDF)
Suomi (FI) (670.86 KB - PDF)
svenska (SV) (673.15 KB - PDF)
Product information
Helixate NexGen : EPAR - Product information
English (EN) (934.15 KB - PDF)
български (BG) (2.17 MB - PDF)
español (ES) (1.17 MB - PDF)
čeština (CS) (1.86 MB - PDF)
dansk (DA) (1.12 MB - PDF)
Deutsch (DE) (1.17 MB - PDF)
eesti keel (ET) (1.14 MB - PDF)
ελληνικά (EL) (2.21 MB - PDF)
français (FR) (1.21 MB - PDF)
hrvatski (HR) (1.23 MB - PDF)
íslenska (IS) (1.01 MB - PDF)
italiano (IT) (1.18 MB - PDF)
latviešu valoda (LV) (1.92 MB - PDF)
lietuvių kalba (LT) (1.23 MB - PDF)
magyar (HU) (1.57 MB - PDF)
Malti (MT) (1.95 MB - PDF)
Nederlands (NL) (1.19 MB - PDF)
norsk (NO) (1 MB - PDF)
polski (PL) (1.93 MB - PDF)
português (PT) (1.16 MB - PDF)
română (RO) (1.24 MB - PDF)
slovenčina (SK) (1.88 MB - PDF)
slovenščina (SL) (1.79 MB - PDF)
Suomi (FI) (1.16 MB - PDF)
svenska (SV) (1.18 MB - PDF)
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)
български (BG) (625.66 KB - PDF)
español (ES) (580.81 KB - PDF)
čeština (CS) (611.81 KB - PDF)
dansk (DA) (580.7 KB - PDF)
Deutsch (DE) (580.46 KB - PDF)
eesti keel (ET) (580.66 KB - PDF)
ελληνικά (EL) (631.23 KB - PDF)
français (FR) (580.57 KB - PDF)
hrvatski (HR) (595.81 KB - PDF)
íslenska (IS) (580.52 KB - PDF)
italiano (IT) (580.46 KB - PDF)
latviešu valoda (LV) (614.96 KB - PDF)
lietuvių kalba (LT) (590.15 KB - PDF)
magyar (HU) (610.4 KB - PDF)
Malti (MT) (614.17 KB - PDF)
Nederlands (NL) (585.56 KB - PDF)
norsk (NO) (580.65 KB - PDF)
polski (PL) (612.89 KB - PDF)
português (PT) (581.98 KB - PDF)
română (RO) (596.88 KB - PDF)
slovenčina (SK) (611.6 KB - PDF)
slovenščina (SL) (596.06 KB - PDF)
Suomi (FI) (580.75 KB - PDF)
svenska (SV) (584.26 KB - PDF)
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)
Helixate NexGen-H-C-0276-A31-0178 : EPAR - Assessment Report - Article 31
English (EN) (905.6 KB - PDF)
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)
български (BG) (844.19 KB - PDF)
español (ES) (658.41 KB - PDF)
čeština (CS) (802.29 KB - PDF)
dansk (DA) (655.05 KB - PDF)
Deutsch (DE) (665.36 KB - PDF)
eesti keel (ET) (654.65 KB - PDF)
ελληνικά (EL) (867.86 KB - PDF)
français (FR) (655.34 KB - PDF)
hrvatski (HR) (699.51 KB - PDF)
italiano (IT) (655.65 KB - PDF)
latviešu valoda (LV) (811.59 KB - PDF)
lietuvių kalba (LT) (699.72 KB - PDF)
magyar (HU) (787.75 KB - PDF)
Malti (MT) (789.62 KB - PDF)
Nederlands (NL) (656.85 KB - PDF)
polski (PL) (802.69 KB - PDF)
português (PT) (663.08 KB - PDF)
română (RO) (707.66 KB - PDF)
slovenčina (SK) (824.85 KB - PDF)
slovenščina (SL) (788.52 KB - PDF)
Suomi (FI) (658.67 KB - PDF)
svenska (SV) (663.08 KB - PDF)
Helixate NexGen-H-C-276-A20-143 : EPAR - Assessment Report - Article 20
English (EN) (798.1 KB - PDF)
Helixate NexGen-H-C-276-WS-193 : EPAR - Assessment Report - Variation
English (EN) (1.3 MB - PDF)
Helixate NexGen : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (660.51 KB - PDF)
News on Helixate NexGen
More information on Helixate NexGen
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)