Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sprycel   
Auth. number : EU/1/06/363
INN : Dasatinib
Orphan status based on designation EU/3/05/338 added on 22/11/2006
Orphan status based on designation EU/3/05/339 added on 22/11/2006
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: L01XE06 - Dasatinib
(See WHO ATC Index)
Indication: SPRYCEL is indicated for the treatment of adult patients with:
- newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.
- chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate.
- Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, 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
26/02/2006 Centralised - Variation EMEA/H/C/709/N/1
Updated with Decision(2007)4027 of 22/08/2007
22/11/2006 Centralised - Authorisation EMEA/H/C/709 (2006)5665 of 20/11/2006
24/08/2007 Centralised - Variation EMEA/H/C/709/II/2 (2007)4027 of 22/08/2007
21/11/2007 Centralised - Variation EMEA/H/C/709/IA/3
Updated with Decision(2008)3390 of 30/06/2008
26/11/2007 Centralised - Variation EMEA/H/C/709/N/4
Updated with Decision(2008)3390 of 30/06/2008
02/07/2008 Centralised - Variation (2008)3390 of 30/06/2008
24/07/2008 Centralised - Variation EMEA/H/C/709/II/8 (2008)3969 of 22/07/2008
13/11/2008 Centralised - Variation EMEA/H/C/709/IB/11
Updated with Decision(2009)669 of 29/01/2009
13/01/2009 Centralised - Variation EMEA/H/C/709/X/7 (2009)87 of 09/01/2009
20/01/2009 Centralised - Variation EMEA/H/C/709/II/9 (2009)188 of 15/01/2009
02/02/2009 Centralised - Variation EMEA/H/C/709/II/13 (2009)669 of 29/01/2009
12/02/2009 Centralised - Variation EMEA/H/C/709/II/12 (2009)1024 of 10/02/2009
26/02/2009 Centralised - Variation EMEA/H/C/709/IB/15
02/03/2009 Centralised - Variation EMEA/H/C/709/II/10, 14 (2009)1466 of 26/02/2009
31/07/2009 Centralised - Variation EMEA/H/C/709/II/16, 17 (2009)6158 of 28/07/2009
21/08/2009 Centralised - Variation EMEA/H/C/709/IA/18
20/01/2010 Centralised - Variation EMEA/H/C/709/IB/19
Updated with Decision(2010)3074 of 05/05/2010
26/03/2010 Centralised - Variation EMEA/H/C/709/IA/21/G
Updated with Decision(2010)5386 of 28/07/2010
07/05/2010 Centralised - Variation EMEA/H/C/709/II/20 (2010)3074 of 05/05/2010
02/08/2010 Centralised - Variation (2010)5386 of 28/07/2010
19/08/2010 Centralised - Variation EMEA/H/C/709/IA/25
Updated with Decision(2010)7541 of 25/10/2010
05/10/2010 Centralised - Variation EMEA/H/C/709/X/22 (2010)6911 of 30/09/2010
27/10/2010 Centralised - Variation EMEA/H/C/709/II/24 (2010)7541 of 25/10/2010
08/12/2010 Centralised - Variation EMEA/H/C/709/II/23 (2010)8969 of 06/12/2010
15/03/2011 Centralised - Variation EMEA/H/C/709/IA/26/G
Updated with Decision(2011)3715 of 23/05/2011
26/05/2011 Centralised - Variation (2011)3715 of 23/05/2011
27/06/2011 Centralised - Variation EMEA/H/C/709/IB/29
Updated with Decision(2011)7177 of 03/10/2011
05/10/2011 Centralised - Renewal EMEA/H/C/709/R/28 (2011)7177 of 03/10/2011
24/01/2012 Centralised - Variation EMEA/H/C/709/II/30 (2012)418 of 20/01/2012
23/02/2012 Centralised - Variation EMEA/H/C/709/II/31 (2012)1263 of 21/02/2012
11/04/2012 Corrigendum (2012)2409 of 04/04/2012
03/09/2012 Centralised - Variation EMEA/H/C/709/II/32 (2012)6128 of 30/08/2012
22/11/2012 Centralised - Variation EMEA/H/C/709/II/33 (2012)8578 of 19/11/2012
25/07/2013 Centralised - Variation EMEA/H/C/709/II/36
21/11/2013 Centralised - Variation EMEA/H/C/709/II/37