🇯🇵 prasugrel/bivalirudin in Japan

prasugrel/bivalirudin (prasugrel/bivalirudin) regulatory status in Japan.

Marketing authorisation

PMDA

Application: Efient
Local brand name: Efient
Status: approved

prasugrel/bivalirudin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

🇪🇺 European Union

Other Cardiovascular approved in Japan

Frequently asked questions

Is prasugrel/bivalirudin approved in Japan?

Yes. PMDA has authorised it.

Who is the marketing authorisation holder for prasugrel/bivalirudin in Japan?

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the originator. The local marketing authorisation holder may differ — check the official source linked above.