🇦🇺 Infasurf in Australia

Infasurf (CALFACTANT) regulatory status in Australia.

Marketing authorisation

TGA

  • Status: likely_approved

Infasurf in other countries

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

Other Respiratory approved in Australia

Frequently asked questions

Is Infasurf approved in Australia?

Yes. TGA has authorised it.

Who is the marketing authorisation holder for Infasurf in Australia?

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