Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cometriq   
Auth. number : EU/1/13/890
INN : cabozantinib
Orphan status based on designation EU/3/08/610 added on 26/03/2014
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
28/05/2014 Centralised - Variation EMEA/H/C/2640/IB/2
17/06/2014 Centralised - Variation EMEA/H/C/2640/IB/3
25/09/2014 Centralised - Variation EMEA/H/C/2640/II/6
25/09/2014 Centralised - Variation EMEA/H/C/2640/II/4/G