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