PMDA — authorised 18 June 2019
- Marketing authorisation holder: Chugai Pharmaceutical
- Status: approved
🇯🇵 Rozlytrek in Japan
PMDA authorised Rozlytrek on 18 June 2019
Marketing authorisations
PMDA
- Application: Rozlytrek
- Local brand name: Rozlytrek
- Status: approved
Rozlytrek 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 Rozlytrek approved in Japan?
Yes. PMDA authorised it on 18 June 2019; PMDA has authorised it.
Who is the marketing authorisation holder for Rozlytrek in Japan?
Chugai Pharmaceutical holds the Japanese marketing authorisation.