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