Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cometriq   
Auth. number : EU/1/13/890
Active substance : cabozantinib
Orphan market exclusivity for "Treatment of medullary thyroid carcinoma" (based on designation EU/3/08/610) started on 26/03/2014
   10 years of market exclusivity
   This orphan market exclusivity will expire on 26/03/2024
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: L01XE26 - Cabozantinib
(See WHO ATC Index)
Indication: Cometriq is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.
For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision
Marketing Authorisation Holder: TMC Pharma Services Ltd
Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, 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
26/03/2014 Centralised - Authorisation EMEA/H/C/2640 (2014)2043 of 21/03/2014
28/04/2014 Centralised - Variation EMEA/H/C/2640/IA/1
Updated with Decision(2015)286 of 19/01/2015
28/05/2014 Centralised - Variation EMEA/H/C/2640/IB/2
Updated with Decision(2015)286 of 19/01/2015
17/06/2014 Centralised - Variation EMEA/H/C/2640/IB/3
Updated with Decision(2015)286 of 19/01/2015
25/09/2014 Centralised - Variation EMEA/H/C/2640/II/4/G
Updated with Decision(2015)286 of 19/01/2015
25/09/2014 Centralised - Variation EMEA/H/C/2640/II/6
Updated with Decision(2015)286 of 19/01/2015
18/12/2014 Centralised - Variation EMEA/H/C/2640/II/5/G
Updated with Decision(2015)3667 of 27/05/2015
21/01/2015 Centralised - Annual renewal EMEA/H/C/2640/R/9 (2015)286 of 19/01/2015
23/04/2015 Centralised - Variation EMEA/H/C/2640/II/13/G
Updated with Decision(2015)3667 of 27/05/2015
29/05/2015 Centralised - 2-Monthly update EMEA/H/C/2640/II/11/G (2015)3667 of 27/05/2015
25/06/2015 Centralised - Variation EMEA/H/C/2640/II/15
Updated with Decision(2016)138 of 11/01/2016
17/12/2015 Centralised - Variation EMEA/H/C/2640/II/18
13/01/2016 Centralised - Annual renewal EMEA/H/C/2640/R/17 (2016)138 of 11/01/2016