TGA
- Status: likely_approved
🇦🇺 Exondys 51 in Australia
Exondys 51 (ETEPLIRSEN) regulatory status in Australia.
Marketing authorisations
TGA
- Status: likely_approved
Exondys 51 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 Exondys 51 approved in Australia?
Yes. TGA has authorised it; TGA has authorised it.
Who is the marketing authorisation holder for Exondys 51 in Australia?
Sarepta is the originator. The local marketing authorisation holder may differ — check the official source linked above.