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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. 


198 result(s) found, displaying 1 to 25
  • Onbevzi

    Australian Prescription Medicine Decision Summary
  • Wezlana

    Australian Prescription Medicine Decision Summary
  • Arexvy

    Arexvy (recombinant respiratory syncytial virus pre-fusion F protein) is approved for individuals 60 years and older for the prevention of lower respiratory tract disease caused by respiratory syncytial virus
  • Raniviz

    Raniviz (ranibizumab) is approved to treat visual impairment issues.
  • Aquipta

    Aquipta (atogepant) is approved for prophylaxis of migraine in adults
  • Givlaari

    Givlaari (givosiran) is approved to treat acute hepatic porphyria.
  • Sohonos

    Sohonos (palovarotene) is approved to reduce the formation of heterotopic ossification.
  • Beyfortus

    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

    Spevigo (spesolimab) is approved for the treatment of flares in adult patients with generalised pustular psoriasis.
  • Heparin Interpharma

    Heparin Interpharma (heparin sodium) is approved for prophylaxis and treatment of deep vein thrombosis in patients 18 years and older.
  • Vafseo

    Vafseo (vadadustat) is approved to treat anaemia associated with chronic kidney disease in adults on chronic maintenance dialysis.
  • Omvoh

    Omvoh (mirikizumab) is approved to treat moderately to severely active ulcerative colitis.
  • Alhemo

    Alhemo (concizumab) is approved to prevent haemophilia.
  • Tibsovo

    Tibsovo (ivosidenib) is approved to treat acute myeloid leukaemia that carries an IDH1 R132 mutation.
  • Vaxchora

    Vaxchora (vibrio cholerae) is approved to prevent disease caused by Vibrio cholerae serogroup O1 in those travelling to cholera-affected countries.
  • Vegzelma

    Vegzelma (bevacizumab) is approved to treat cancer.
  • Xenpozyme

    Xenpozyme (olipudase alfa) is approved for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD).
  • Columvi

    Columvi (glofitamab) is provisionally approved to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
  • Nurtec ODT

    Nurtec ODT (rimegepant (as sulfate)) is approved to treat migraine
  • Exarane/Exarane Forte

    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

    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

    TGA decision: Idefirix (imlifidase) has provisional approval for desensitisation treatment of adult kidney transplant candidates.
  • Alhemo

    ​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

    We have approved Retevmo (selpercatinib) to treat adult patients with Non-Small Cell Lung Cancer (NSCLC).
  • Andexxa

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

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