🇦🇺 Prolia in Australia

Prolia (DENOSUMAB) regulatory status in Australia.

Marketing authorisations

TGA

  • Status: likely_approved

TGA

  • Status: likely_approved

TGA

  • Status: likely_approved

TGA

  • Status: likely_approved

TGA

  • Status: likely_approved

TGA

  • Status: likely_approved

Prolia in other countries

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

Other Oncology approved in Australia

Frequently asked questions

Is Prolia approved in Australia?

Yes. TGA has authorised it; TGA has authorised it; TGA has authorised it.

Who is the marketing authorisation holder for Prolia in Australia?

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