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