Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Xigris
Auth. number : EU/1/02/225
INN : Drotrecogin alfa (activated)
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AD - Enzymes
Chemical substance: B01AD10 - Drotrecogin alfa (activated)
(See WHO ATC Index)
Indication: Treatment of adult patients with severe sepsis with multiple organ failure
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland

  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
22/08/2002 Centralised - Authorisation EMEA/H/C/396 (2002)3176 of 22/08/2002
26/02/2003 Centralised - Variation EMEA/H/C/396/N/1 (2003)683 of 24/02/2003
02/06/2003 Centralised - Variation EMEA/H/C/396/II/2
13/08/2003 Centralised - Variation EMEA/H/C/396/II/3 (2003)3035 of 11/08/2003
26/02/2004 Centralised - Annual reassessment EMEA/H/C/396/S/5 (2004)634 of 23/02/2004
07/05/2004 Centralised - Variation EMEA/H/C/396/IB/9
Updated with Decision(2004)4698 of 30/11/2004
09/06/2004 Centralised - Variation EMEA/H/C/396/II/7
17/06/2004 Centralised - Variation EMEA/H/C/396/II/8 (2004)2189 of 15/06/2004
22/09/2004 Centralised - Variation EMEA/H/C/396/II/10
30/11/2004 Centralised - Variation EMEA/H/C/396/IB/9 (2004)4698 of 30/11/2004
11/01/2005 Centralised - Variation EMEA/H/C/396/IB/15
27/01/2005 Centralised - Variation EMEA/H/C/396/II/14 (2005)204 of 25/01/2005
31/01/2005 Centralised - Variation EMEA/H/C/396/II/12
06/07/2005 Centralised - Annual reassessment EMEA/H/C/396/S/13 (2005)2655 of 04/07/2005
18/11/2005 Centralised - Variation EMEA/H/C/396/II/16 (2005)4491 of 15/11/2005
25/11/2005 Centralised - Variation EMEA/H/C/396/II/11
19/12/2005 Centralised - Variation EMEA/H/C/396/II/8
11/01/2006 Corrigendum
26/04/2006 Centralised - Annual reassessment EMEA/H/C/396/S/17 (2006)1751 of 24/04/2006
03/05/2006 Centralised - Variation EMEA/H/C/396/II/19
04/04/2007 Centralised - Variation EMEA/H/C/396/II/22, 20 (2007)1598 of 02/04/2007
27/04/2007 Centralised - Annual reassessment EMEA/H/C/396/S/21 (2007)1914 of 25/04/2007
27/07/2007 Centralised - Renewal EMEA/H/C/396/R/23 (2007)3582 of 20/07/2007
11/02/2008 Centralised - Variation EMEA/H/C/396/IA/25
02/04/2008 Centralised - Annual reassessment EMEA/H/C/396/S/24 (2008)1277 of 31/03/2008
09/12/2008 Centralised - Variation EMEA/H/C/396/II/26, 27 (2008)8165 of 04/12/2008
10/12/2009 Centralised - Annual reassessment EMEA/H/C/396/S/28 (2009)10056 of 08/12/2009
04/05/2010 Centralised - Annual reassessment EMEA/H/C/396/S/29
03/06/2010 Centralised - Variation EMEA/H/C/396/IB/30
30/11/2010 Centralised - Annual reassessment EMEA/H/C/396/S/31
11/03/2011 Centralised - Variation EMEA/H/C/396/IB/32
18/04/2011 Centralised - Variation EMEA/H/C/396/IA/33
30/11/2011 Centralised - Withdrawal (2011)8962 of 28/11/2011