Zykadia
ceritinib
Table of contents
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.
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Zykadia : EPAR - Medicine overview (PDF/77.76 KB)
First published: 04/06/2015
Last updated: 30/05/2018 -
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Zykadia : EPAR - Risk-management-plan summary (PDF/76.2 KB)
First published: 04/06/2015
Last updated: 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 |
Product information
16/02/2022 Zykadia - EMEA/H/C/003819 - R/0042
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.