European Commission
Public Health
Accessibility tools
Service tools
Language selector
- Current languageen
Navigation path
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Fasturtec
|
| Auth. number : | EU/1/00/170 |
| INN : | rasburicase |
| ATC: | V - Various V03 - All other therapeutic products V03A - All other therapeutic products V03AF - Detoxifying agents for antineoplastic treatment 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| 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/8 | ||||
| Updated with Decision(2005)3051 of 01/08/2005 | ||||||
| 10/12/2004 | Centralised - Variation | EMEA/H/C/331/IA/9 | ||||
| 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 | ||||