Caprelsa

RSS

vandetanib

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

Overview

This is a summary of the European public assessment report (EPAR) for Caprelsa. 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 Caprelsa.

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

This EPAR was last updated on 14/11/2018

Authorisation details

Product details
Name
Caprelsa
Agency product number
EMEA/H/C/002315
Active substance
Vandetanib
International non-proprietary name (INN) or common name
vandetanib
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.

Publication details
Marketing-authorisation holder
Genzyme Europe BV
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
16/02/2012
Contact address
Gooimeer 10
1411 DD Naarden
Netherlands

Product information

16/10/2018 Caprelsa - EMEA/H/C/002315 - IAIN/0033/G

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 AND IMMUNOMODULATING AGENTS

Therapeutic indication

Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

Caprelsa is indicated in adults, children and adolescents aged 5 years and older.

For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

Assessment history

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