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