PMDA
- Application: Nubeqa
- Local brand name: Nubeqa
- Status: approved
🇯🇵 Darolutamide (BAY 1841788) in Japan
Darolutamide (BAY 1841788) (Darolutamide (BAY 1841788)) regulatory status in Japan.
Marketing authorisation
Darolutamide (BAY 1841788) 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 Darolutamide (BAY 1841788) approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for Darolutamide (BAY 1841788) in Japan?
Canadian Cancer Trials Group is the originator. The local marketing authorisation holder may differ — check the official source linked above.