Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Tasigna   
Auth. number : EU/1/07/422
Active substance : Nilotinib
Orphan market exclusivity for "Treatment of chronic myeloid leukaemia" (based on designation EU/3/06/375) started on 21/11/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 21/11/2017
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE08 - Nilotinib
(See WHO ATC Index)
Indication: Tasigna is indicated for the treatment of adult patients with:
- newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase,
- chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, 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
20/11/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/798 (2007)5665 of 19/11/2007
21/11/2007 Centralised - Authorisation EMEA/H/C/798 (2007)5664 of 19/11/2007
04/08/2008 Centralised - Variation EMEA/H/C/798/IB/2
Updated with Decision(2009)17 of 05/01/2009
02/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/3-4
08/01/2009 Centralised - Variation EMEA/H/C/798/II/5 (2009)17 of 05/01/2009
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/10
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/12
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/14
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/11
21/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/13
02/03/2009 Centralised - Variation EMEA/H/C/798/II/9 (2009)1469 of 26/02/2009
09/04/2009 Centralised - Variation EMEA/H/C/798/II/7 (2009)2866 of 07/04/2009
23/04/2009 Centralised - Variation EMEA/H/C/798/II/6 (2009)3134 of 21/04/2009
10/06/2009 Centralised - Variation EMEA/H/C/798/II/8 (2009)4576 of 08/06/2009
21/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/21
21/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/22
21/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/23
21/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/20
21/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/19
30/07/2009 Centralised - Variation EMEA/H/C/798/II/17 (2009)6103 of 27/07/2009
04/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IB/24
10/08/2009 Centralised - Variation EMEA/H/C/798/II/15 (2009)6355 of 06/08/2009
27/08/2009 Centralised - Variation EMEA/H/C/798/II/16, 18 (2009)6667 of 25/08/2009
07/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/II/25
24/12/2009 Centralised - Variation EMEA/H/C/798/II/26 (2009)10731 of 22/12/2009
16/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IA/30/G
25/03/2010 Centralised - Variation EMEA/H/C/798/II/27 (2010)2014 of 23/03/2010
31/08/2010 Centralised - Variation EMEA/H/C/798/II/31 (2010)6026 of 26/08/2010
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/II/32
28/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/798/IG/25/G
23/12/2010 Centralised - Variation EMEA/H/C/798/X/28 (2010)9643 of 20/12/2010
23/12/2010 Centralised - Variation EMEA/H/C/798/II/29 (2010)9644 of 20/12/2010
21/01/2011 Centralised - Variation EMEA/H/C/798/IG/32/G
Updated with Decision(2011)3726 of 23/05/2011
24/05/2011 Centralised - Variation EMEA/H/C/798/IA/35/G
Updated with Decision(2011)4467 of 17/06/2011
25/05/2011 Centralised - Variation EMEA/H/C/798/II/33 (2011)3726 of 23/05/2011
23/06/2011 Centralised - Variation EMEA/H/C/798/II/34 (2011)4467 of 17/06/2011
28/09/2011 Centralised - Variation EMEA/H/C/798/IB/38/G
Updated with Decision(2011)8672 of 22/11/2011
24/11/2011 Centralised - Variation EMEA/H/C/798/II/36 (2011)8672 of 22/11/2011
21/12/2011 Centralised - Variation EMEA/H/C/798/II/37 (2011)9953 of 19/12/2011
10/05/2012 Centralised - Variation EMEA/H/C/798/IA/48
Updated with Decision(2012)4517 of 27/06/2012
02/07/2012 Centralised - Variation EMEA/H/C/798/II/46 (2012)4517 of 27/06/2012
24/09/2012 Centralised - Renewal EMEA/H/C/798/R/47 (2012)6702 of 20/09/2012
16/01/2013 Centralised - Variation EMEA/H/C/798/IB/54
Updated with Decision(2013)9834 of 20/12/2013
17/01/2013 Centralised - Variation EMEA/H/C/798/II/51/G
Updated with Decision(2013)9834 of 20/12/2013
30/05/2013 Centralised - Variation EMEA/H/C/798/II/58
Updated with Decision(2013)9834 of 20/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/798/II/60
Updated with Decision(2013)9834 of 20/12/2013
18/12/2013 Centralised - Variation EMEA/H/C/798/II/62, 64
Updated with Decision(2014)9997 of 15/12/2014
02/01/2014 Centralised - Yearly update (2013)9834 of 20/12/2013
20/03/2014 Centralised - Variation EMEA/H/C/798/II/65
Updated with Decision(2014)9997 of 15/12/2014
26/06/2014 Centralised - Variation EMEA/H/C/798/II/67
Updated with Decision(2014)9997 of 15/12/2014
26/06/2014 Centralised - Variation EMEA/H/C/798/II/68
Updated with Decision(2014)9997 of 15/12/2014
03/12/2014 Centralised - Variation EMEA/H/C/798/II/70/G
Updated with Decision(2014)9997 of 15/12/2014
18/12/2014 Centralised - Yearly update (2014)9997 of 15/12/2014
27/05/2015 Centralised - Variation EMEA/H/C/798/IB/76
Updated with Decision(2016)3520 of 02/06/2016
29/05/2015 Centralised - Variation EMEA/H/C/798/IAin/77
Updated with Decision(2016)3520 of 02/06/2016
25/06/2015 Centralised - Variation EMEA/H/C/798/II/75
Updated with Decision(2016)3520 of 02/06/2016
24/09/2015 Centralised - Variation EMEA/H/C/798/II/73
Updated with Decision(2016)3520 of 02/06/2016
11/05/2016 Centralised - Variation EMEA/H/C/798/IAin/82
Updated with Decision(2017)3648 of 22/05/2017
06/06/2016 Centralised - Yearly update (2016)3520 of 02/06/2016
24/05/2017 Centralised - Yearly update (2017)3648 of 22/05/2017
30/05/2017 Centralised - 2-Monthly update EMEA/H/C/798/II/84/G (2017)3742 of 24/05/2017