🇦🇺 Skyclarys in Australia

Skyclarys (OMAVELOXOLONE) regulatory status in Australia.

Marketing authorisation

TGA

  • Local brand name: Skyclarys
  • Status: approved

Skyclarys in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in Australia

Frequently asked questions

Is Skyclarys approved in Australia?

Yes. TGA has authorised it.

Who is the marketing authorisation holder for Skyclarys in Australia?

Biogen Us is the originator. The local marketing authorisation holder may differ — check the official source linked above.