PMDA
- Application: Betanis
- Local brand name: Betanis
- Status: approved
🇯🇵 Betanis in Japan
Betanis (Betanis) regulatory status in Japan.
Marketing authorisation
Betanis in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in Japan
Frequently asked questions
Is Betanis approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for Betanis in Japan?
Astellas Pharma Inc is the originator. The local marketing authorisation holder may differ — check the official source linked above.