Skip to main content

Australian prescription medicine decision summaries

These decision summaries provide an overview of our evaluation process leading to the registration of a new prescription medicine.

Use the filters below to narrow your search.

Filter results

You can narrow down the results using the filters.

For more information please visit the Australian prescription medicine decision summaries information page. 

Search

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.

Help us improve the Therapeutic Goods Administration site