Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Quixidar
Auth. number : EU/1/02/207
INN : Fondaparinux sodium
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AX - Other antithrombotic agents
Chemical substance: B01AX05 - Fondaparinux
(See WHO ATC Index)
Indication: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, 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 is 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
25/03/2002 Centralised - Authorisation EMEA/H/C/404 (2002)1276 of 21/03/2002
11/12/2002 Centralised - Variation EMEA/H/C/404/I/3
16/01/2003 Centralised - Variation EMEA/H/C/404/I/2 (2003)308 of 14/01/2003
24/03/2003 Centralised - Variation EMEA/H/C/404/II/1 (2003)951 of 20/03/2003
22/09/2003 Centralised - Variation EMEA/H/C/404/I/6
29/10/2003 Centralised - Variation EMEA/H/C/404/X/5 (2003)4009 of 24/10/2003
11/11/2003 Centralised - Variation EMEA/H/C/404/II/4 (2003)4173 of 07/11/2003
13/01/2004 Centralised - Variation EMEA/H/C/404/IB/9
22/07/2004 Centralised - Variation EMEA/H/C/404/IB/11
22/07/2004 Centralised - Variation EMEA/H/C/404/IB/8
15/09/2004 Centralised - Variation EMEA/H/C/404/N/13
Updated with Decision(2005)207 of 25/01/2005
16/11/2004 Centralised - Variation EMEA/H/C/404/X/7 (2004)4420 of 12/11/2004
01/12/2004 Centralised - Variation EMEA/H/C/404/IA/15
Updated with Decision(2005)207 of 25/01/2005
14/01/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/404/T/14 (2005)98 of 12/01/2005
18/01/2005 Centralised - Variation EMEA/H/C/404/IB/17, 18, 19
27/01/2005 Centralised - Variation EMEA/H/C/404/II/10 (2005)207 of 25/01/2005
17/05/2005 Centralised - Variation EMEA/H/C/404/IA/20
11/07/2005 Centralised - Variation EMEA/H/C/404/II/12 (2005)2694 of 07/07/2005
08/02/2006 Centralised - Variation EMEA/H/C/404/IB/22
Updated with Decision(2006)4165 of 12/09/2006
24/07/2006 Centralised - Variation EMEA/H/C/404/IA/23
04/09/2006 Centralised - Variation EMEA/H/C/404/IA/26
15/09/2006 Centralised - Variation (2006)4165 of 12/09/2006
25/09/2006 Centralised - Variation EMEA/H/C/404/IA/28
11/12/2006 Centralised - Variation EMEA/H/C/404/IB/30
Updated with Decision(2007)1857 of 20/04/2007
24/04/2007 Centralised - Renewal EMEA/H/C/404/R/27 (2007)1857 of 20/04/2007
16/05/2007 Centralised - Variation EMEA/H/C/404/IA/31
31/08/2007 Centralised - Variation EMEA/H/C/404/II/24 (2007)4121 of 29/08/2007
31/08/2007 Centralised - Variation EMEA/H/C/404/X/25 (2007)4120 of 29/08/2007
05/09/2007 Centralised - Variation EMEA/H/C/404/II/32 (2007)4184 of 03/09/2007
11/10/2007 Centralised - Variation EMEA/H/C/404/II/33 (2007)5058 of 09/10/2007
24/10/2007 Centralised - Variation EMEA/H/C/404/N/34
13/03/2008 Centralised - Withdrawal (2008)1061 of 11/03/2008