Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fasturtec   
Auth. number : EU/1/00/170
INN : rasburicase
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AF - Detoxifying agents for antineoplastic treatment
Chemical substance: V03AF07 - Rasburicase
(See WHO ATC Index)
Indication: Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with a high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy.
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France

  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
28/02/2001 Centralised - Authorisation EMEA/H/C/331 (2001)283 of 23/02/2001
22/04/2002 Centralised - Variation EMEA/H/C/331/II/1 (2002)1555 of 18/04/2002
06/06/2003 Centralised - Variation EMEA/H/C/331/I/3 (2003)1841 of 04/06/2003
03/07/2003 Centralised - Variation EMEA/H/C/331/II/2 (2003)2233 of 30/06/2003
16/10/2003 Centralised - Variation EMEA/H/C/331/I/4
24/06/2004 Centralised - Variation EMEA/H/C/331/IB/5
03/09/2004 Centralised - Variation EMEA/H/C/331/N/6
Updated with Decision(2005)3051 of 01/08/2005
04/10/2004 Centralised - Variation EMEA/H/C/331/N/13
Updated with Decision(2006)452 of 09/02/2006
11/11/2004 Centralised - Variation EMEA/H/C/331/IB/7
10/12/2004 Centralised - Variation EMEA/H/C/331/IA/9
Updated with Decision(2005)3051 of 01/08/2005
10/12/2004 Centralised - Variation EMEA/H/C/331/IA/8
Updated with Decision(2005)3051 of 01/08/2005
29/03/2005 Centralised - Variation EMEA/H/C/331/IA/10
Updated with Decision(2005)3051 of 01/08/2005
03/08/2005 Centralised - Variation EMEA/H/C/331/IA/14
03/08/2005 Centralised - Variation (2005)3051 of 01/08/2005
08/08/2005 Centralised - Variation EMEA/H/C/331/II/11, 12
13/02/2006 Centralised - Renewal EMEA/H/C/331/R/15 (2006)452 of 09/02/2006
02/05/2006 Centralised - Variation EMEA/H/C/331/II/16 (2006)1825 of 27/04/2006
04/05/2006 Centralised - Variation EMEA/H/C/331/II/17
09/08/2006 Centralised - Variation EMEA/H/C/331/II/18 (2006)3665 of 07/08/2006
07/09/2006 Centralised - Variation EMEA/H/C/331/II/19 (2006)4054 of 01/09/2006
01/03/2007 Centralised - Variation EMEA/H/C/331/IA/20
Updated with Decision(2007)3919 of 10/08/2007
14/08/2007 Centralised - Variation EMEA/H/C/331/II/21 (2007)3919 of 10/08/2007
23/10/2007 Centralised - Variation EMEA/H/C/331/II/23 (2007)5233 of 19/10/2007
24/10/2007 Centralised - Variation EMEA/H/C/331/II/22
13/02/2008 Centralised - Variation EMEA/H/C/331/N/26
Updated with Decision(2009)557 of 26/01/2009
03/03/2008 Centralised - Variation EMEA/H/C/331/II/24 (2008)837 of 28/02/2008
28/02/2009 Centralised - Variation EMEA/H/C/331/II/27 (2009)557 of 26/01/2009
02/03/2009 Centralised - Variation EMEA/H/C/331/II/28 (2009)1455 of 26/02/2009
06/05/2009 Centralised - Variation EMEA/H/C/331/N/29
Updated with Decision(2012)1921 of 19/03/2012
21/03/2012 Centralised - Variation EMEA/H/C/331/II/30, 31 (2012)1921 of 19/03/2012
08/06/2012 Centralised - Variation EMEA/H/C/331/IA/32
Updated with Decision(2012)3560 of 25/05/2012
08/06/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/331/T/33 (2012)3560 of 25/05/2012
26/10/2012 Centralised - Variation EMEA/H/C/331/II/34 (2012)7765 of 25/10/2012
07/11/2012 Centralised - Variation EMEA/H/C/331/IAin/36
Updated with Decision(2013)8331 of 20/11/2013
15/11/2013 Centralised - Variation EMEA/H/C/331/IA/39
22/11/2013 Centralised - Variation EMEA/H/C/331 (2013)8331 of 20/11/2013