MFDS — authorised 19 September 2016
- Marketing authorisation holder: SAREPTA THERAPEUTICS INC
- Status: likely_approved
MFDS authorised Exondys 51 on 19 September 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 19 September 2016.
SAREPTA THERAPEUTICS INC holds the South Korean marketing authorisation.