MFDS
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Status: likely_approved
Mebutina (MEBUTAMATE) regulatory status in South Korea.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. MFDS has authorised it.
MEDPOINTE PHARM HLC holds the South Korean marketing authorisation.