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 13/09/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

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
12
Date of issue of marketing authorisation valid throughout the European Union
20/03/2014
Contact address
65, quai Georges Gorse
92100 Boulogne-Billancourt
France

Product information

27/08/2018 Cometriq - EMEA/H/C/002640 - PSUSA/00010180/201711

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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

Assessment history

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