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