EMA — authorised 26 February 2015
- Status: approved
🇪🇺 Zykadia in European Union
EMA authorised Zykadia on 26 February 2015
Marketing authorisations
EMA — authorised 6 May 2015
- Application: EMEA/H/C/003819
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Zykadia
- 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.
- Status: approved
Zykadia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Zykadia approved in European Union?
Yes. EMA authorised it on 26 February 2015; EMA authorised it on 6 May 2015.
Who is the marketing authorisation holder for Zykadia in European Union?
Novartis is the originator. The local marketing authorisation holder may differ — check the official source linked above.