🇯🇵 OPC-34712 in Japan

OPC-34712 (OPC-34712) regulatory status in Japan.

Marketing authorisation

PMDA

Application: Rexulti Partial Change Approval
Local brand name: Rexulti Partial Change Approval
Status: approved

OPC-34712 in other countries

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

🇪🇺 European Union
🇺🇸 United States

Frequently asked questions

Is OPC-34712 approved in Japan?

Yes. PMDA has authorised it.

Who is the marketing authorisation holder for OPC-34712 in Japan?

Otsuka Pharmaceutical Development & Commercialization, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.