PMDA
- Application: Vyndaqel Initial Approval
- Local brand name: Vyndaqel Initial Approval
- Status: approved
🇯🇵 Vyndaqel in Japan
Vyndaqel (Tafamidis Meglumine) regulatory status in Japan.
Marketing authorisations
PMDA
- Application: Vyndaqel Partial Change Approval
- Local brand name: Vyndaqel Partial Change Approval
- Status: approved
Vyndaqel 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 Vyndaqel approved in Japan?
Yes. PMDA has authorised it; PMDA has authorised it.
Who is the marketing authorisation holder for Vyndaqel in Japan?
Foldrx Pharms is the originator. The local marketing authorisation holder may differ — check the official source linked above.