PMDA
- Application: Orkedia Initial Approval
- Local brand name: Orkedia Initial Approval
- Status: approved
🇯🇵 KHK7580 in Japan
KHK7580 (KHK7580) regulatory status in Japan.
Marketing authorisations
PMDA
- Application: Orkedia Partial Change Approval
- Local brand name: Orkedia Partial Change Approval
- Status: approved
Other Cardiovascular approved in Japan
Frequently asked questions
Is KHK7580 approved in Japan?
Yes. PMDA has authorised it; PMDA has authorised it.
Who is the marketing authorisation holder for KHK7580 in Japan?
Kyowa Kirin Co., Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.