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Australian prescription medicine decision summaries

Search our decision summaries for the registration of new prescription medicines.

For more information, visit the About Australian prescription medicine decision summaries information page.

We have redesigned our prescription medicine decision summaries (AusPMDSs) to make it easier to understand how prescription medicines are registered in Australia. 

The redesigned AusPMDSs will offer clear, accessible information about recent medicine registration decisions.

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226 result(s) found, displaying 151 to 175
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • TGA decision: Ovaleap (follitropin alfa) is approved to treat anovulatory infertility in woman who are unresponsive to clomiphene citrate.
  • TGA decision: Spravato (esketamine hydrochloride) is approved for the treatment of treatment resistant depression.
  • TGA decision: Ruxience (rituximab) is approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, GPA and MPA.
  • TGA decision: Zolgensma (onasemnogene abeparvovec) is approved to treat patients less than 9 months old with symptomatic/pre-symptomatic SMA.
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • Australian prescription medicine decision summary
  • TGA decision: Trientine Waymade (trientine dihydrochloride) is approved to treat Wilson's disease patients intolerant to penicillamine.
  • TGA decision: TERROSA (teriparatide) is approved to treat osteoporosis in postmenopausal women and primary osteoporosis in men.
  • TGA decision: ENSPRYNG (satralizumab) is approved to treat adults with neuromyelitis optica spectrum disorders who have an AQP4-IgG.
  • TGA decision: Reagila (cariprazine hydrochloride) is approved to treat schizophrenia in adult patients.