🇦🇺 Gilenya in Australia

Gilenya (FINGOLIMOD) regulatory status in Australia.

Marketing authorisation

TGA

  • Status: likely_approved

Gilenya in other countries

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

Other Immunology approved in Australia

Frequently asked questions

Is Gilenya approved in Australia?

Yes. TGA has authorised it.

Who is the marketing authorisation holder for Gilenya in Australia?

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