Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Arixtra   
Auth. number : EU/1/02/206
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 adults 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 adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of Venous Thromboembolic Events (VTE) in adult 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. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.
Marketing Authorisation Holder: Aspen Pharma Trading Limited
3016 Lake Drive Citywest Business Campus Dublin 24 Ireland

  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/403 (2002)1274 of 21/03/2002
11/12/2002 Centralised - Variation EMEA/H/C/403/I/3
17/01/2003 Centralised - Variation EMEA/H/C/403/I/2 (2003)317 of 15/01/2003
24/03/2003 Centralised - Variation EMEA/H/C/403/II/1 (2003)952 of 20/03/2003
22/09/2003 Centralised - Variation EMEA/H/C/403/I/6
28/10/2003 Centralised - Variation EMEA/H/C/403/X/5 (2003)4008 of 24/10/2003
12/11/2003 Centralised - Variation EMEA/H/C/403/II/4 (2003)4176 of 07/11/2003
13/01/2004 Centralised - Variation EMEA/H/C/403/IB/9
22/07/2004 Centralised - Variation EMEA/H/C/403/IB/8
22/07/2004 Centralised - Variation EMEA/H/C/403/IB/11
15/09/2004 Centralised - Variation EMEA/H/C/403/N/13
Updated with Decision(2005)206 of 25/01/2005
16/11/2004 Centralised - Variation EMEA/H/C/403/X/7 (2004)4419 of 12/11/2004
01/12/2004 Centralised - Variation EMEA/H/C/403/IA/15
Updated with Decision(2005)206 of 25/01/2005
14/01/2005 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/403/T/14 (2005)99 of 12/01/2005
18/01/2005 Centralised - Variation EMEA/H/C/403/IB/17, 18, 19
27/01/2005 Centralised - Variation EMEA/H/C/403/II/10 (2005)206 of 25/01/2005
17/05/2005 Centralised - Variation EMEA/H/C/403/IA/20
11/07/2005 Centralised - Variation EMEA/H/C/403/II/12 (2005)2693 of 07/07/2005
08/02/2006 Centralised - Variation EMEA/H/C/403/IB/22
Updated with Decision(2006)4162 of 12/09/2006
24/07/2006 Centralised - Variation EMEA/H/C/403/IA/23
04/09/2006 Centralised - Variation EMEA/H/C/404/IA/26
15/09/2006 Centralised - Variation (2006)4162 of 12/09/2006
25/09/2006 Centralised - Variation EMEA/H/C/403/IA/28
11/12/2006 Centralised - Variation EMEA/H/C/403/IB/30
Updated with Decision(2007)1858 of 20/04/2007
24/04/2007 Centralised - Renewal EMEA/H/C/403/R/27 (2007)1858 of 20/04/2007
16/05/2007 Centralised - Variation EMEA/H/C/403/IA/31
31/08/2007 Centralised - Variation EMEA/H/C/403/II/24 (2007)4123 of 29/08/2007
31/08/2007 Centralised - Variation EMEA/H/C/403/X/25 (2007)4122 of 29/08/2007
05/09/2007 Centralised - Variation EMEA/H/C/403/II/32 (2007)4182 of 03/09/2007
11/10/2007 Centralised - Variation EMEA/H/C/403/II/33 (2007)5056 of 09/10/2007
24/10/2007 Centralised - Variation EMEA/H/C/403/N/34
Updated with Decision(2008)1186 of 19/03/2008
26/03/2008 Centralised - Variation EMEA/H/C/403/II/35 (2008)1186 of 19/03/2008
26/08/2008 Centralised - Variation EMEA/H/C/403/II/36 (2008)4653 of 22/08/2008
17/12/2008 Centralised - Variation EMEA/H/C/403/IA/40
24/12/2008 Centralised - Variation EMEA/H/C/403/II/37 (2008)8971 of 22/12/2008
04/03/2009 Centralised - Variation EMEA/H/C/403/II/39
27/03/2009 Centralised - Variation EMEA/H/C/403/II/38, 41 (2009)2313 of 25/03/2009
05/10/2009 Centralised - Variation EMEA/H/C/403/II/42
22/01/2010 Centralised - Variation EMEA/H/C/403/II/43 (2010)409 of 20/01/2010
09/04/2010 Centralised - Variation EMEA/H/C/403/IB/46
27/05/2010 Centralised - Variation EMEA/H/C/403/II/44
02/09/2010 Centralised - Variation EMEA/H/C/403/II/45 (2010)6106 of 31/08/2010
27/01/2011 Centralised - Variation EMEA/H/C/403/IG/34/G
Updated with Decision(2011)3601 of 18/05/2011
02/03/2011 Centralised - Variation EMEA/H/C/403/II/47 (2011)1466 of 28/02/2011
20/05/2011 Centralised - Variation EMEA/H/C/403/II/48 (2011)3601 of 18/05/2011
24/10/2011 Centralised - Variation EMEA/H/C/403/II/49 (2011)7678 of 20/10/2011
03/01/2012 Centralised - Variation EMEA/H/C/403/IB/51
Updated with Decision(2012)4757 of 04/07/2012
06/07/2012 Centralised - Variation (2012)4757 of 04/07/2012
14/12/2012 Centralised - Variation EMEA/H/C/403/IB/54
Updated with Decision(2013)8704 of 29/11/2013
18/04/2013 Centralised - Variation EMEA/H/C/403/IA/279
Updated with Decision(2013)8704 of 29/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/403/II/56
Updated with Decision(2013)8704 of 29/11/2013
27/11/2013 Centralised - Variation EMEA/H/C/403/N/59
Updated with Decision(2014)6195 of 26/08/2014
02/12/2013 Centralised - Variation (2013)8704 of 29/11/2013
03/06/2014 Centralised - Variation EMEA/H/C/403/N/60
Updated with Decision(2014)6195 of 26/08/2014
28/08/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/403/T/63 (2014)6195 of 26/08/2014