Cometriq

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cabozantinib

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Cometriq. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cometriq.

For practical information about using Cometriq, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 05/04/2023

Authorisation details

Product details
Name
Cometriq
Agency product number
EMEA/H/C/002640
Active substance
cabozantinib
International non-proprietary name (INN) or common name
cabozantinib
Therapeutic area (MeSH)
Thyroid Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Ipsen Pharma
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
21/03/2014
Contact address

65 Quai Georges Gorse
92100 Boulogne-Billancourt
France

Product information

26/09/2022 Cometriq - EMEA/H/C/002640 - PSUSA/00010180/202111

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.

Assessment history

Changes since initial authorisation of medicine

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