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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.
You can narrow down the results using the filters.
For more information please visit the Australian prescription medicine decision summaries information page.
- Prescription medicine decision summaryArexvy (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
- Prescription medicine decision summaryBeyfortus (nirsevimab) is approved for the prevention of respiratory syncytial virus (RSV) in neonates, infants and vulnerable children up to the age of 24 months.
- Prescription medicine decision summaryXenpozyme (olipudase alfa) is approved for the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD).
- Prescription medicine decision summaryExarane (enoxaparin sodium) is approved to prevent and/or treat thromboembolic disorders, angina and non-Q-wave myocardial infarction and ST-segment Elevation Myocardial Infarction.
- Prescription medicine decision summaryTGA decision: Tavneos (avacopan) is approved to treat adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).
- Prescription medicine decision summaryTGA 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.
- Prescription medicine decision summaryWe have provisionally approved Andexxa (andexanet alfa) for patients treated with a direct factor Xa inhibitor, when reversal of anticoagulation is needed.