PMDA
- Application: Steboronine
- Local brand name: Steboronine
- Status: approved
🇯🇵 Steboronine in Japan
Steboronine (borofalan (10B)) regulatory status in Japan.
Marketing authorisation
Steboronine 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 Steboronine approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for Steboronine in Japan?
Stella Pharma is the originator. The local marketing authorisation holder may differ — check the official source linked above.