Xalkori

RSS

crizotinib

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

Overview

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

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

This EPAR was last updated on 10/09/2018

Authorisation details

Product details
Name
Xalkori
Agency product number
EMEA/H/C/002489
Active substance
crizotinib
International non-proprietary name (INN) or common name
crizotinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XE16
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
Pfizer Europe MA EEIG
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
23/10/2012
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

31/08/2018 Xalkori - EMEA/H/C/002489 - T/0059

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

Xalkori is indicated for the first-line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

Xalkori is indicated for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC).

Assessment history

Changes since initial authorisation of medicine

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