MFDS — authorised 12 December 2019
- Marketing authorisation holder: SAREPTA THERAPS INC
- Status: likely_approved
🇰🇷 Vyondys 53 in South Korea
MFDS authorised Vyondys 53 on 12 December 2019
Marketing authorisation
Vyondys 53 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in South Korea
Frequently asked questions
Is Vyondys 53 approved in South Korea?
Yes. MFDS authorised it on 12 December 2019.
Who is the marketing authorisation holder for Vyondys 53 in South Korea?
SAREPTA THERAPS INC holds the South Korean marketing authorisation.