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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.

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

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225 result(s) found, displaying 101 to 125

  • Yuflyma

    Prescription medicine decision summary
    TGA Decision: Yuflyma (adalimumab) is approved to treat multiple auto-immune conditions.

  • Bimzelx

    Prescription medicine decision summary
    TGA Decision: Bimzelx (bimekizumab) is approved to treat moderate to severe plaque psoriasis in adult patients.

  • Vaxelis

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

  • Vumerity

    Prescription medicine decision summary
    TGA Decision: Vumerity (diroximel fumarate) is approved to treat relapsing multiple sclerosis.

  • Ponvory

    Prescription medicine decision summary
    TGA decision: Ponvory (ponesimod) is approved to treat relapsing forms of multiple sclerosis.

  • Xpovio

    Prescription medicine decision summary
    TGA decision: Xpovio (selinexor) is approved to treat multiple myeloma.

  • Evusheld

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

  • Sogroya

    Prescription medicine decision summary
    TGA decision: Sogroya (somapacitan) is approved to treat adults with growth hormone deficiency (AGHD).

  • Jemperli

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

  • Rybelsus

    Prescription medicine decision summary
    TGA decision: Rybelsus (semaglutide) is approved to treat type 2 diabetes mellitus

  • Empaveli

    Prescription medicine decision summary
    TGA decision: Empaveli (pegcetacoplan) is approved to treat adult patients with paroxysmal nocturnal haemoglobinuria (PNH).

  • Tepmetko

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

  • Vaxneuvance

    Prescription medicine decision summary
    Australian prescription medicine decision summary

  • Lagevrio

    Prescription medicine decision summary
    TGA decision: Lagevrio (molnupiravir) is approved for the treatment of adults with COVID-19.

  • Lutetium (177Lu) Chloride

    Prescription medicine decision summary
    ANSTO Lutetium (177Lu) chloride (lutetium (177 Lu) chloride) is approved to treat non resectable or metastatic neuroendocrine tumours.

  • Paxlovid

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

  • Nuvaxovid

    Prescription medicine decision summary
    Australian prescription medicine decision summary

  • Koselugo

    Prescription medicine decision summary
    TGA decision: Koselugo (selumetinib) is approved to treat paediatric patients aged 2 years and above, with neurofibromatosis type 1 (NF1)

  • Ngenla

    Prescription medicine decision summary
    TGA decision: Ngenla (somatrogon) is approved to treat paediatric growth disturbance

  • Kerendia

    Prescription medicine decision summary
    Australian prescription medicine decision summary

  • Nextstellis

    Prescription medicine decision summary
    TGA decision: Nextstellis (estetrol monohydrate and drospirenone) is approved for use by women of reproductive potential to prevent pregnancy.

  • Regkirona

    Prescription medicine decision summary
    Australian prescription medicine decision summary

  • Nexviazyme

    Prescription medicine decision summary
    TGA decision: Nexviazyme (avalglucosidase alfa) is approved to treat Pompe disease (acid α-glucosidase deficiency)

  • Verquvo

    Prescription medicine decision summary
    TGA decision: Verquvo (vericiguat) is approved to treat symptomatic chronic heart failure

  • Rholistiq

    Prescription medicine decision summary
    TGA decision: Rholistiq (belumosudil mesilate) is approved to treat chronic graft-versus-host disease (GVHD)

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