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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. 

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186 result(s) found, displaying 1 to 25
  • 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.
  • Minjuvi

    We have approved Minjuvi (tafasitamab) to treat diffuse large B-cell lymphoma (DLBCL).
  • Imjudo

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

    The medicine Tecvayli (teclistamab) has been approved by the TGA to treat multiple myeloma.
  • Intrarosa

    ​TGA decision: Intrarosa (prasterone) is approved to treat vulvar and vaginal atrophy in postmenopausal women.
  • Esperoct

    ​TGA decision: Esperoct (turoctocog alfa pegol) is approved to treat haemophilia A.
  • Gavreto

    TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with advanced or metastatic rearranged during transfection- fusion positive thyroid cancer.
  • Tibsovo

    TGA decision: Tibsovo (ivosidenib) is approved to treat cancer.
  • Gavreto

    TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with locally advanced or metastatic rearranged during transfection fusion-positive non-small cell lung cancer.
  • Jivi

    TGA decision: Jivi (damoctocog alfa pegol) is approved to treat adults and adolescents (12 years of age and older) with haemophilia A
  • Sunlenca

    TGA decision: Sunlenca (lenacapavir sodium) is approved to treat multidrug resistant HIV-1 infection.
  • Radicava

    TGA decision: Radicava (edaravone) is approved to treat adults with a diagnosis of amyotrophic lateral sclerosis.

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