Cabometyx

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cabozantinib

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

Overview

An overview of Cabometyx and why it is authorised in the EU

Cabometyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer). It is used in patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor’. It is also used in patients who have not had previous treatment and whose cancer is at moderate or high risk of rapidly getting worse.

Cabometyx contains the active substance cabozantinib.

This EPAR was last updated on 07/06/2018

Authorisation details

Product details
Name
Cabometyx
Agency product number
EMEA/H/C/004163
Active substance
cabozantinib s-malate
International non-proprietary name (INN) or common name
cabozantinib
Therapeutic area (MeSH)
Carcinoma, Renal Cell
Anatomical therapeutic chemical (ATC) code
L01XE26
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.

Publication details
Marketing-authorisation holder
Ipsen Pharma
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
08/09/2016
Contact address
65 Quai Georges Gorse
92100 Boulogne-Billancourt
France

Product information

07/05/2018 Cabometyx - EMEA/H/C/004163 - II/0003

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

Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC):

  • in treatment-naïve adults with intermediate or poor risk,
  • in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.

Assessment history

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