PMDA
- Application: Tivicay
- Local brand name: Tivicay
- Status: approved
🇯🇵 Dolutegravir Sodium Monohydrate in Japan
Dolutegravir Sodium Monohydrate (Dolutegravir Sodium Monohydrate) regulatory status in Japan.
Marketing authorisation
Dolutegravir Sodium Monohydrate 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 Dolutegravir Sodium Monohydrate approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for Dolutegravir Sodium Monohydrate in Japan?
University of Colorado, Denver is the originator. The local marketing authorisation holder may differ — check the official source linked above.