MFDS
- Status: likely_approved
🇰🇷 Axumin in South Korea
Axumin (fluciclovine (18F)) regulatory status in South Korea.
Marketing authorisation
Axumin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in South Korea
Frequently asked questions
Is Axumin approved in South Korea?
Yes. MFDS has authorised it.
Who is the marketing authorisation holder for Axumin in South Korea?
Blue Earth Diagnostics Ltd is the originator. The local marketing authorisation holder may differ — check the official source linked above.