PMDA
- Application: Zykadia
- Local brand name: Zykadia
- Status: approved
🇯🇵 Zykadia in Japan
Zykadia (ceritinib) regulatory status in Japan.
Marketing authorisation
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 Japan
Frequently asked questions
Is Zykadia approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for Zykadia in Japan?
Novartis is the originator. The local marketing authorisation holder may differ — check the official source linked above.