MFDS
- Marketing authorisation holder: INTRABIO
- Status: likely_approved
Aqneursa (LEVACETYLLEUCINE) 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.
INTRABIO holds the South Korean marketing authorisation.