MFDS — authorised 30 March 2016
- Marketing authorisation holder: GENTIUM SRL
- Status: likely_approved
MFDS authorised Defitelio on 30 March 2016
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. MFDS authorised it on 30 March 2016.
GENTIUM SRL holds the South Korean marketing authorisation.