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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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262 result(s) found, displaying 126 to 150

  • Spikevax Bivalent Original/Omicron

    Prescription medicine decision summary
    Spikevax Bivalent Original/Omicron (elasomeran and imelasomeran) was approved for the prevention of COVID-19.

  • Voxzogo

    Prescription medicine decision summary
    TGA decision: VOXZOGO (vosoritide) is approved to treat achondroplasia in patients 2 years of age and older whose epiphyses are not closed.

  • Exkivity

    Prescription medicine decision summary
    TGA decision: Exkivity (mobocertinib) is approved to treat lung cancer

  • Trastucip and Tuzucip

    Prescription medicine decision summary
    TGA decision: Trastucip and Tuzucip (trastuzumab) are approved to treat breast cancer.

  • Scemblix

    Prescription medicine decision summary
    Scemblix (asciminib) is approved to treat Philadelphia chromosome-positive chronic myeloid leukaemia.

  • Padcev

    Prescription medicine decision summary
    Padcev (enfortumab vedotin) is approved to treat adult patients with locally advanced or metastatic urothelial cancer.

  • Xembify

    Prescription medicine decision summary
    TGA decision: Xembify (normal immunoglobulin human) is approved to treat primary immunodeficiency diseases (PID).

  • Vyxeos

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

  • Isturisa

    Prescription medicine decision summary
    Australian prescription medicine decision summary

  • Kimmtrak

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

  • Lumakras

    Prescription medicine decision summary
    TGA Decision: Lumakras (sotorasib) is approved to treat adult patients with non-small cell lung cancer (NSCLC).

  • Saphnelo

    Prescription medicine decision summary
    TGA Decision: Saphnelo (anifrolumab) is approved to treat adult patients with active systemic lupus erythematosus (SLE).

  • 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