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