Zykadia

RSS

ceritinib

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

Overview

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 25/02/2022

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
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
18
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

16/02/2022 Zykadia - EMEA/H/C/003819 - R/0042

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

How useful was this page?

Add your rating
Average
3 ratings