Kogenate Bayer
Lapsed
This medicine's authorisation has lapsed
octocog alfa
MedicineHumanLapsed
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Kogenate Bayer has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Kogenate Bayer : EPAR - Summary for the public
English (EN) (637.91 KB - PDF)
First published: Last updated:
български (BG) (741.72 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
español (ES) (638.17 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
čeština (CS) (719.83 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
dansk (DA) (638.04 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
Deutsch (DE) (639.63 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
eesti keel (ET) (636.77 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
ελληνικά (EL) (746.22 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
français (FR) (639.44 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
hrvatski (HR) (659.51 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
italiano (IT) (637.55 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
latviešu valoda (LV) (748.66 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
lietuvių kalba (LT) (673.39 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
magyar (HU) (704.25 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
Malti (MT) (741.05 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
Nederlands (NL) (638.12 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
polski (PL) (719.09 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
português (PT) (638.45 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
română (RO) (670.28 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
slovenčina (SK) (720.31 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
slovenščina (SL) (703.65 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
Suomi (FI) (637.24 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
svenska (SV) (638.15 KB - PDF)
First published: 12/05/2009Last updated: 04/05/2018
Product information
Kogenate Bayer : EPAR - Product information
English (EN) (1.17 MB - PDF)
First published: Last updated:
български (BG) (2.85 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
español (ES) (1.18 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
čeština (CS) (2.29 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
dansk (DA) (1.18 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
Deutsch (DE) (1.26 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
eesti keel (ET) (1.16 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
ελληνικά (EL) (2.92 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
français (FR) (1.21 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
hrvatski (HR) (1.25 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
íslenska (IS) (1.09 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
italiano (IT) (1.23 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
latviešu valoda (LV) (2.35 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
lietuvių kalba (LT) (1.27 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
magyar (HU) (2.31 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
Malti (MT) (2.36 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
Nederlands (NL) (1.23 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
norsk (NO) (1.11 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
polski (PL) (2.34 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
português (PT) (1.21 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
română (RO) (1.25 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
slovenčina (SK) (2.27 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
slovenščina (SL) (2.25 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
Suomi (FI) (1.18 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
svenska (SV) (1.22 MB - PDF)
First published: 12/11/2009Last updated: 04/05/2018
Latest procedure affecting product information:
A31/0185
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).
Kogenate Bayer : EPAR - All authorised presentations
English (EN) (578.86 KB - PDF)
First published: Last updated:
български (BG) (670.85 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
español (ES) (578.11 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
čeština (CS) (621.59 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
dansk (DA) (577.87 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
Deutsch (DE) (579.76 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
eesti keel (ET) (597.86 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
ελληνικά (EL) (650.81 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
français (FR) (577.29 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
hrvatski (HR) (588.8 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
íslenska (IS) (577.27 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
italiano (IT) (578.07 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
latviešu valoda (LV) (624.29 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
lietuvių kalba (LT) (591.67 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
magyar (HU) (619.95 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
Malti (MT) (32 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
Nederlands (NL) (579.71 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
norsk (NO) (577.7 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
polski (PL) (622.3 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
português (PT) (577.78 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
română (RO) (591.02 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
slovenčina (SK) (621.51 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
slovenščina (SL) (608.87 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
Suomi (FI) (578.02 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
svenska (SV) (578.47 KB - PDF)
First published: 21/01/2008Last updated: 04/03/2016
Product details
- Name of medicine
- Kogenate Bayer
- 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/000275
- Marketing authorisation holder
- Bayer AG
Bayer AG
51368 Leverkusen
Germany - Marketing authorisation issued
- 04/08/2000
- Lapse of marketing authorisation
- 31/12/2022
- Revision
- 30
Assessment history
Kogenate Bayer : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (1.24 MB - PDF)
First published: Last updated:
Kogenate Bayer-H-C-0275-A31-0185 : EPAR - Assessment Report - Article 31
AdoptedReference Number: EMA/763977/2017
English (EN) (797.26 KB - PDF)
First published: Last updated:
Kogenate Bayer-H-C-275-A20-150 : EPAR - Assessment Report - Article 20
AdoptedReference Number: EMA/10430/2014
English (EN) (723.67 KB - PDF)
First published: Last updated:
Kogenate Bayer-H-C-275-A20-150 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
English (EN) (629.74 KB - PDF)
First published: Last updated:
Kogenate Bayer-H-C-275-WS-193 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/282360/2012
English (EN) (1.22 MB - PDF)
First published: Last updated:
Kogenate Bayer : EPAR - Steps taken after authorisation when a cutoff date has been used
English (EN) (648.56 KB - PDF)
First published: Last updated:
News on Kogenate Bayer
More information on Kogenate Bayer
Public statement on Kogenate Bayer : Cessation of validity of the marketing authorisation in the European Union
Reference Number: EMA/9416/2023
English (EN) (106.64 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 Kogenate Bayer
Topics
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