TGA
- Status: likely_approved
🇦🇺 Amondys 45 in Australia
Amondys 45 (CASIMERSEN) regulatory status in Australia.
Marketing authorisation
Amondys 45 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 Amondys 45 approved in Australia?
Yes. TGA has authorised it.
Who is the marketing authorisation holder for Amondys 45 in Australia?
Sarepta is the originator. The local marketing authorisation holder may differ — check the official source linked above.