Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sutent   
Auth. number : EU/1/06/347
Active substance : sunitinib
Orphan market exclusivity for "Treatment of malignant gastrointestinal stromal tumours" (based on designation EU/3/05/267) started on 15/01/2007
   10 years of market exclusivity
   This orphan market exclusivity has ended on 23/07/2008
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE04 - Sunitinib
(See WHO ATC Index)
Indication: Gastrointestinal stromal tumour (GIST)
SUTENT is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.
Metastatic renal cell carcinoma (MRCC)
SUTENT is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Pancreatic neuroendocrine tumours (pNET)
SUTENT is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Experience with SUTENT as first-line treatment is limited.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
24/07/2006 Centralised - Authorisation EMEA/H/C/687 (2006)3363 of 19/07/2006
08/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IA/3
15/01/2007 Centralised - Authorisation (orphan status) EMEA/H/C/687/S/1 (2007)118 of 11/01/2007
19/01/2007 Centralised - Variation EMEA/H/C/687/II/2 (2007)181 of 17/01/2007
23/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IA/4
26/10/2007 Centralised - Variation EMEA/H/C/687/II/5 (2007)5302 of 24/10/2007
26/11/2007 Centralised - Variation EMEA/H/C/687/II/6 (2007)5813 of 22/11/2007
29/01/2008 Centralised - Variation EMEA/H/C/687/II/7 (2008)391 of 25/01/2008
14/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IA/8
31/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IA/10
27/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IB/9
23/07/2008 Centralised - (orphan status)
26/08/2008 Centralised - Variation EMEA/H/C/687/II/11 (2008)4649 of 22/08/2008
04/11/2008 Centralised - Variation EMEA/H/C/687/II/13 (2008)6598 of 30/10/2008
12/02/2009 Centralised - Variation EMEA/H/C/687/II/14 (2009)1026 of 10/02/2009
03/06/2009 Centralised - Variation EMEA/H/C/687/X/20 (2009)4337 of 29/05/2009
05/08/2009 Centralised - Variation EMEA/H/C/687/II/17 (2009)6255 of 03/08/2009
24/08/2009 Centralised - Variation EMEA/H/C/687/II/15 (2009)6585 of 20/08/2009
04/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IB/19
13/10/2009 Centralised - Variation EMEA/H/C/687/IB/20
Updated with Decision(2010)1771 of 15/03/2010
30/10/2009 Centralised - Variation EMEA/H/C/687/II/16 (2009)8511 of 28/10/2009
17/03/2010 Centralised - Variation (2010)1771 of 15/03/2010
25/03/2010 Centralised - Variation EMEA/H/C/687/II/18 (2010)2003 of 23/03/2010
26/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IB/23
14/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IA/24/G
05/07/2010 Centralised - Variation EMEA/H/C/687/II/22 (2010)4669 of 01/07/2010
03/12/2010 Centralised - Variation EMEA/H/C/687/II/21 (2010)8632 of 29/11/2010
23/12/2010 Centralised - Variation EMEA/H/C/687/II/26, 27/G (2010)9607 of 20/12/2010
25/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IB/25/G
28/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/687/IG/44/G
22/08/2011 Centralised - Variation EMEA/H/C/687/II/28 (2011)6050 of 18/08/2011
11/01/2012 Centralised - Renewal EMEA/H/C/687/R/30, EMEA/H/C/687/II/31/G (2012)94 of 09/01/2012
26/03/2012 Centralised - Variation EMEA/H/C/687/IB/34
Updated with Decision(2012)6698 of 20/09/2012
24/09/2012 Centralised - Variation (2012)6698 of 20/09/2012
15/11/2012 Centralised - Variation EMEA/H/C/687/II/39
Updated with Decision(2013)8160 of 15/11/2013
19/11/2012 Centralised - Variation EMEA/H/C/687/II/38 (2012)8486 of 15/11/2012
17/01/2013 Centralised - Variation EMEA/H/C/687/II/40/G
Updated with Decision(2013)8160 of 15/11/2013
21/03/2013 Centralised - Variation EMEA/H/C/687/II/42
Updated with Decision(2013)8160 of 15/11/2013
12/07/2013 Centralised - Notification EMEA/H/C/687/N/44
Updated with Decision(2013)8160 of 15/11/2013
19/11/2013 Centralised - Yearly update (2013)8160 of 15/11/2013
23/01/2014 Centralised - Variation EMEA/H/C/687/II/48/G
Updated with Decision(2015)1027 of 17/02/2015
26/06/2014 Centralised - Variation EMEA/H/C/687/II/51
Updated with Decision(2015)1027 of 17/02/2015
24/07/2014 Centralised - Variation EMEA/H/C/687/II/50/G
Updated with Decision(2015)1027 of 17/02/2015
18/12/2014 Centralised - Variation EMEA/H/C/687/II/53/G
Updated with Decision(2015)1027 of 17/02/2015
19/02/2015 PSUSA - Modification EMEA/H/C/687/PSUV/52 (2015)1027 of 17/02/2015
26/02/2015 Centralised - Variation EMEA/H/C/687/II/54
Updated with Decision(2016)931 of 11/02/2016
24/06/2015 Centralised - Notification EMEA/H/C/262/N/55
Updated with Decision(2016)931 of 11/02/2016
25/06/2015 Centralised - Variation EMEA/H/C/687/II/56
Updated with Decision(2016)931 of 11/02/2016
15/02/2016 Centralised - Yearly update (2016)931 of 11/02/2016
25/02/2016 Centralised - Variation EMEA/H/C/687/II/60/G