Zykadia

RSS

ceritinib

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

Overview

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

Zykadia is a cancer medicine used on its own to treat adults with a type of lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced. It is only used if the NSCLC is ‘ALK-positive’, which means that the cancer cells have certain defects affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).

Zykadia contains the active substance ceritinib.

This EPAR was last updated on 12/07/2018

Authorisation details

Product details
Name
Zykadia
Agency product number
EMEA/H/C/003819
Active substance
ceritinib
International non-proprietary name (INN) or common name
ceritinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
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.

Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
06/05/2015
Contact address
Vista Building Elm Park
Merrion Road
Dublin 4
Ireland

Product information

06/07/2018 Zykadia - EMEA/H/C/003819 - II/0016

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

Zykadia is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) previously treated with crizotinib.

Assessment history

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