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