PMDA
- Application: Orfadin
- Local brand name: Orfadin
- Status: approved
🇯🇵 Nitisinone in Arm A in Japan
Nitisinone in Arm A (Nitisinone in Arm A) regulatory status in Japan.
Marketing authorisation
Nitisinone in Arm A 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 Nitisinone in Arm A approved in Japan?
Yes. PMDA has authorised it.
Who is the marketing authorisation holder for Nitisinone in Arm A in Japan?
Swedish Orphan Biovitrum is the originator. The local marketing authorisation holder may differ — check the official source linked above.