MFDS
- Status: likely_approved
🇰🇷 Hu38Sb19 in South Korea
Hu38Sb19 (isatuximab) regulatory status in South Korea.
Marketing authorisation
Hu38Sb19 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 Hu38Sb19 approved in South Korea?
Yes. MFDS has authorised it.
Who is the marketing authorisation holder for Hu38Sb19 in South Korea?
Sanofi is the originator. The local marketing authorisation holder may differ — check the official source linked above.