TGA
- Status: likely_approved
🇦🇺 Mysoline in Australia
Mysoline (PRIMIDONE) regulatory status in Australia.
Marketing authorisation
Mysoline in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in Australia
Frequently asked questions
Is Mysoline approved in Australia?
Yes. TGA has authorised it.
Who is the marketing authorisation holder for Mysoline in Australia?
Bausch Health is the originator. The local marketing authorisation holder may differ — check the official source linked above.