Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Iclusig   
Auth. number : EU/1/13/839
Active substance : ponatinib
Orphan market exclusivity for "Treatment of acute lymphoblastic leukaemia" (based on designation EU/3/09/715) started on 03/07/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 03/07/2023
Orphan market exclusivity for "Treatment of chronic myeloid leukaemia" (based on designation EU/3/09/716) started on 03/07/2013
   10 years of market exclusivity
   This orphan market exclusivity will expire on 03/07/2023
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: L01XE24 - Ponatinib
(See WHO ATC Index)
Indication: Iclusig is indicated in adult patients with
• chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Marketing Authorisation Holder: ARIAD Pharma Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, 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
03/07/2013 Centralised - Authorisation EMEA/H/C/2695 (2013)4238 of 01/07/2013
09/08/2013 Centralised - Variation EMEA/H/C/2695/IAin/1/G
Updated with Decision(2013)9848 of 20/12/2013
27/12/2013 Centralised - 2-Monthly update EMEA/H/C/2695/II/2 (2013)9848 of 20/12/2013
20/03/2014 Centralised - Variation EMEA/H/C/2695/II/7
Updated with Decision(2014)6799 of 18/09/2014
22/05/2014 Centralised - Variation EMEA/H/C/2695/II/5/G
Updated with Decision(2014)6799 of 18/09/2014
17/09/2014 Centralised - Variation EMEA/H/C/2695/IAin/15
Updated with Decision(2015)239 of 15/01/2015
22/09/2014 PSUSA - Modification EMEA/H/C/2695/PSUV/9 (2014)6799 of 18/09/2014
19/01/2015 Referral EMEA/H/C/2695/A-20/3 (2015)239 of 15/01/2015
02/02/2015 Centralised - Variation EMEA/H/C/2695/IB/16/G
Updated with Decision(2015)6535 of 18/09/2015
26/03/2015 Centralised - Variation EMEA/H/C/2695/II/17
Updated with Decision(2015)6535 of 18/09/2015
26/03/2015 Centralised - Variation EMEA/H/C/2695/II/20
Updated with Decision(2015)6535 of 18/09/2015
06/05/2015 Centralised - Variation EMEA/H/C/2695/IB/21/G
Updated with Decision(2015)6535 of 18/09/2015
22/09/2015 PSUSA - Modification EMEA/H/C/PSUSA/10128/201412 (2015)6535 of 18/09/2015
01/12/2015 Centralised - Variation EMEA/H/C/2695/X/23 (2015)8594 of 27/11/2015
28/01/2016 Centralised - Variation EMEA/H/C/2695/II/28
Updated with Decision(2016)1912 of 22/03/2016
29/03/2016 PSUSA - Modification EMEA/H/C/PSUSA/10128/201506 (2016)1912 of 22/03/2016
11/05/2016 Centralised - Variation EMEA/H/C/2695/IAIN/31