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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 51 to 75

  • Raniviz

    Prescription medicine decision summary
    Raniviz (ranibizumab) is approved to treat visual impairment issues.

  • Aquipta

    Prescription medicine decision summary
    Aquipta (atogepant) is approved for prophylaxis of migraine in adults

  • Givlaari

    Prescription medicine decision summary
    Givlaari (givosiran) is approved to treat acute hepatic porphyria.

  • Sohonos

    Prescription medicine decision summary
    Sohonos (palovarotene) is approved to reduce the formation of heterotopic ossification.

  • Beyfortus

    Prescription medicine decision summary
    Beyfortus (nirsevimab) is approved for the prevention of respiratory syncytial virus (RSV) in neonates, infants and vulnerable children up to the age of 24 months.

  • Spevigo

    Prescription medicine decision summary
    Spevigo (spesolimab) is approved for the treatment of flares in adult patients with generalised pustular psoriasis.

  • Heparin Interpharma

    Prescription medicine decision summary
    Heparin Interpharma (heparin sodium) is approved for prophylaxis and treatment of deep vein thrombosis in patients 18 years and older.

  • Vafseo

    Prescription medicine decision summary
    Vafseo (vadadustat) is approved to treat anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.

  • Omvoh

    Prescription medicine decision summary
    Omvoh (mirikizumab) is approved to treat moderately to severely active ulcerative colitis.

  • Alhemo

    Prescription medicine decision summary
    Alhemo (concizumab) is approved to prevent haemophilia.

  • Tibsovo

    Prescription medicine decision summary
    Tibsovo (ivosidenib) is approved to treat acute myeloid leukaemia that carries an IDH1 R132 mutation.

  • Vaxchora

    Prescription medicine decision summary
    Vaxchora (vibrio cholerae) is approved to prevent disease caused by Vibrio cholerae serogroup O1 in those travelling to cholera-affected countries.

  • Vegzelma

    Prescription medicine decision summary
    Vegzelma (bevacizumab) is approved to treat cancer.

  • Xenpozyme

    Prescription medicine decision summary
    Xenpozyme (olipudase alfa) is approved for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD).

  • Columvi

    Prescription medicine decision summary
    Columvi (glofitamab) is provisionally approved to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

  • Nurtec ODT

    Prescription medicine decision summary
    Nurtec ODT (rimegepant (as sulfate)) is approved to treat migraine

  • Exarane/Exarane Forte

    Prescription medicine decision summary
    Exarane (enoxaparin sodium) is approved to prevent and/or treat thromboembolic disorders, angina and non-Q-wave myocardial infarction and ST-segment Elevation Myocardial Infarction.

  • Tavneos

    Prescription medicine decision summary
    TGA decision: Tavneos (avacopan) is approved to treat adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).

  • Idefirix

    Prescription medicine decision summary
    TGA decision: Idefirix (imlifidase) has provisional approval for desensitisation treatment of adult kidney transplant candidates.

  • Alhemo

    Prescription medicine decision summary
    ​TGA decision: Alhemo is approved where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have haemophilia B.

  • Retevmo

    Prescription medicine decision summary
    We have approved Retevmo (selpercatinib) to treat adult patients with Non-Small Cell Lung Cancer (NSCLC).

  • Andexxa

    Prescription medicine decision summary
    We have provisionally approved Andexxa (andexanet alfa) for patients treated with a direct factor Xa inhibitor, when reversal of anticoagulation is needed.

  • Minjuvi

    Prescription medicine decision summary
    We have approved Minjuvi (tafasitamab) to treat diffuse large B-cell lymphoma (DLBCL).

  • Imjudo

    Prescription medicine decision summary
    The medicine Imjudo (tremelimumab), in combination with durvalumab, is approved to treat adult patients with unresectable hepatocellular carcinoma (uHCC).

  • Tecvayli

    Prescription medicine decision summary
    The medicine Tecvayli (teclistamab) has been approved by the TGA to treat multiple myeloma.