← Drug database

Zykadia (ceritinib)

Region
🇪🇺 EU
Active substance
ceritinib
Company
Novartis Europharm Limited
Status
Authorised
Therapeutic area
Carcinoma, Non-Small-Cell Lung
CHMP opinion
Thu 26 Feb 2015
EU approval
Wed 06 May 2015
Application
EMEA/H/C/003819
ATC
L01XE
Official record
www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Follow Zykadia

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.