🇦🇺 NITISINONE in Australia

NITISINONE (NITISINONE) regulatory status in Australia.

Marketing authorisation

TGA

  • Local brand name: Orfadin
  • Status: approved

NITISINONE in other countries

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

Frequently asked questions

Is NITISINONE approved in Australia?

Yes. TGA has authorised it.

Who is the marketing authorisation holder for NITISINONE in Australia?

Marketing authorisation holder not available in our data.