International work-sharing initiative - baloxavir marboxil (Xofluza)

TGA

5 March 2020 - The Therapeutic Goods Administration (TGA) has approved a new medicine for the treatment of influenza (flu) as part of an international work-sharing initiative.

Baloxavir marboxil (Xofluza) is indicated for:

the treatment of uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are:

  • otherwise healthy, or
  • at high risk of developing influenza complications.

Xofluza was registered on the Australian Register of Therapeutic Goods following an evaluation under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Active Substance work-sharing initiative. This initiative strengthens international partnerships and provides Australians with improved access to the most recent and innovative treatment options.

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Michael Wonder

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Michael Wonder