TGA
- Status: likely_approved
🇦🇺 Vyondys 53 in Australia
Vyondys 53 (GOLODIRSEN) regulatory status in Australia.
Marketing authorisations
TGA
- Status: likely_approved
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 Australia
Frequently asked questions
Is Vyondys 53 approved in Australia?
Yes. TGA has authorised it; TGA has authorised it.
Who is the marketing authorisation holder for Vyondys 53 in Australia?
Sarepta is the originator. The local marketing authorisation holder may differ — check the official source linked above.