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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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Published date

245 result(s) found, displaying 101 to 125

  • Verorab

    Prescription medicine decision summary
    Verorab (inactivated rabies virus) is approved to treat rabies.

  • Livtencity

    Prescription medicine decision summary
    Livtencity (maribavir) is approved to treat cytomegalovirus (CMV).

  • Camzyos

    Prescription medicine decision summary
    Camzyos (mavacamten) is approved to treat cardiomyopathy.

  • Trecondi

    Prescription medicine decision summary
    Trecondi (treosulfan) is approved to treat cancer

  • Ciptunec/Ardalicip

    Prescription medicine decision summary
    TGA decision: Ciptunec Ardalicip (adalimumab) is approved to treat arthritis.

  • Pemazyre

    Prescription medicine decision summary
    TGA decision: Pemazyre (pemigatinib) is approved to treat cancer

  • Byooviz

    Prescription medicine decision summary
    TGA decision: Byooviz (ranibizumab) is approved to treat visual impairment.

  • Filpegla

    Prescription medicine decision summary
    TGA decision: Filpegla (pegfilgrastim) is approved for the treatment of cancer patients following chemotherapy.

  • 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.