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Australian prescription medicine decision summaries

These decision summaries provide an overview of our evaluation process leading to the registration of a new prescription medicine.

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

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134 result(s) found, displaying 1 to 25
  • Byooviz

    TGA decision: Byooviz (ranibizumab) is approved to treat visual impairment.
  • Spikevax Bivalent Original/Omicron

    Spikevax Bivalent Original/Omicron (elasomeran and imelasomeran) was approved for the prevention of COVID-19.
  • Filpegla

    TGA decision: Filpegla (pegfilgrastim) is approved for the treatment of cancer patients following chemotherapy.
  • Exkivity

    TGA decision: Exkivity (mobocertinib) is approved to treat lung cancer
  • Vyxeos

    TGA decision: VYXEOS (daunorubicin and cytarabine) is approved to treat therapy-related acute myeloid leukaemia and AML-MRC.
  • Isturisa

    Australian prescription medicine decision summary
  • Kimmtrak

    TGA decision: KIMMTRAK (tebentafusp) is approved to treat unresectable or metastatic uveal melanoma in HLA-A*02:01 positive patient.
  • Lumakras

    TGA Decision: Lumakras (sotorasib) is approved to treat adult patients with non-small cell lung cancer (NSCLC).
  • Saphnelo

    TGA Decision: Saphnelo (anifrolumab) is approved to treat adult patients with active systemic lupus erythematosus (SLE).
  • Yuflyma

    TGA Decision: Yuflyma (adalimumab) is approved to treat multiple auto-immune conditions.
  • Bimzelx

    TGA Decision: Bimzelx (bimekizumab) is approved to treat moderate to severe plaque psoriasis in adult patients.
  • Vaxelis

    TGA Decision: Vaxelis (DTPa5-HB-IPV-Hib) is approved as a vaccine for diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib.
  • Vumerity

    TGA Decision: Vumerity (diroximel fumarate) is approved to treat relapsing multiple sclerosis.
  • Ponvory

    TGA decision: Ponvory (ponesimod) is approved to treat relapsing forms of multiple sclerosis.
  • Xpovio

    TGA decision: Xpovio (selinexor) is approved to treat multiple myeloma.
  • Evusheld

    TGA decision: Evusheld (tixagevimab/cilgavimab) is approved for the treatment of pre-exposure prophylaxis of COVID-19.
  • Sogroya

    TGA decision: Sogroya (somapacitan) is approved to treat adults with growth hormone deficiency (AGHD).
  • Jemperli

    TGA decision: Jemperli (dostarlimab) is approved to treat patients with recurrent or advanced mismatch repair deficient endometrial cancer.
  • Rybelsus

    TGA decision: Rybelsus (semaglutide) is approved to treat type 2 diabetes mellitus
  • Empaveli

    TGA decision: Empaveli (pegcetacoplan) is approved to treat adult patients with paroxysmal nocturnal haemoglobinuria (PNH).
  • Tepmetko

    TGA decision: Tepmetko (tepotinib) is approved to treat locally advanced or metastatic non-small cell lung cancer (NSCLC).
  • Vaxneuvance

    Australian prescription medicine decision summary
  • Lagevrio

    TGA decision: Lagevrio (molnupiravir) is approved for the treatment of adults with COVID-19.
  • Lutetium (177Lu) Chloride

    ANSTO Lutetium (177Lu) chloride (lutetium (177 Lu) chloride) is approved to treat non resectable or metastatic neuroendocrine tumours.
  • Paxlovid

    TGA decision: Paxlovid (nirmatrelvir/ritonavir) is approved for the treatment of adults with COVID-19.

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