Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: ATryn   
Auth. number : EU/1/06/355
INN : antithrombin alfa
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AB - Heparin group
Chemical substance: B01AB02 - Antithrombin
(See WHO ATC Index)
Indication: Prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency. ATryn is normally given in association with heparin or low molecular weight heparin
Marketing Authorisation Holder: GTC Biotherapeutics UK Limited
10 Norwich Street, London EC4A 1BD, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
02/08/2006 Centralised - Authorisation EMEA/H/C/587 (2006)3494 of 28/07/2006
20/12/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/587/T/1 (2006)7021 of 18/12/2006
27/07/2007 Centralised - Variation EMEA/H/C/587/IB/3
Updated with Decision(2008)746 of 18/02/2008
02/08/2007 Centralised - Variation EMEA/H/C/587/IA/4
Updated with Decision(2008)746 of 18/02/2008
02/08/2007 Centralised - Variation EMEA/H/C/587/IA/5
Updated with Decision(2008)746 of 18/02/2008
25/09/2007 Centralised - Variation EMEA/H/C/587/II/2
03/10/2007 Centralised - Variation EMEA/H/C/587/IA/6
10/01/2008 Centralised - Variation EMEA/H/C/587/IA/8
20/02/2008 Centralised - Annual reassessment EMEA/H/C/587/S/7 (2008)746 of 18/02/2008
10/03/2009 Centralised - Annual reassessment EMEA/H/C/587/S/9 (2009)1716 of 06/03/2009
28/07/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/587/T/10 (2009)5989 of 23/07/2009
21/06/2010 Centralised - Annual reassessment EMEA/H/C/587/S/11 (2010)4214 of 17/06/2010
10/08/2011 Centralised - Renewal EMEA/H/C/587/R/12 (2011)5836 of 05/08/2011
06/03/2012 Centralised - Annual reassessment EMEA/H/C/587/S/13 (2012)1493 of 02/03/2012
22/06/2012 Centralised - Variation EMEA/H/C/587/II/15/G
Updated with Decision(2012)7923 of 29/10/2012
22/06/2012 Centralised - Variation EMEA/H/C/587/II/14/G
Updated with Decision(2012)7923 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7923 of 29/10/2012
08/10/2013 Centralised - Annual reassessment EMEA/H/C/587/S/20 (2013)6699 of 04/10/2013