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/174 KB)
First published: 04/06/2015
Last updated: 26/08/2019
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
13
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Date of issue of marketing authorisation valid throughout the European Union |
06/05/2015
|
Contact address |
Product information
13/01/2020 Zykadia - EMEA/H/C/003819 - IB/0031/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 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.