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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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162 result(s) found, displaying 1 to 25
  • Radicava

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

    Nuceiva (prabotulinumtoxinA) is approved to treat glabellar lines.
  • Doptelet

    Doptelet (avatrombopag maleate) is approved to treat thrombocytopenia in adult patients.
  • Mounjaro

    Mounjaro (tirzepatide) is approved to treat diabetes.
  • Welireg

    Welireg (belzutifan) is approved to treat adult patients with von Hippel-Lindau (VHL) disease
  • Evusheld

    Evusheld (tixagevimab and cilgavimab) is approved to treat COVID-19
  • Rybrevant

    TGA decision: Rybrevant (amivantamab) is approved to treat lung cancer
  • Prevenar 20

    TGA decision: Prevenar 20 (Pneumococcal purified capsular polysaccharides) is approved to prevent pneumococcal disease.
  • Sotyktu

    Sotyktu (deucravacitinib) is approved to treat plaque psoriasis.
  • Letybo

    TGA decision: Letybo (letibotulinumtoxinA) is approved to treat the appearance of moderate to severe glabellar frown lines in adults.
  • Onpattro

    Onpattro (patisiran) is approved to treat polyneuropathy.
  • Korsuva

    Korsuva (difelikefalin acetate) is approved to treat chronic kidney disease
  • Vazkepa

    Vazkepa (Icosapent ethyl) is approved to treat cardiovascular disease.
  • Vabysmo

    Vabysmo (faricimab) is approved to treat macular degeneration.
  • Verorab

    Verorab (inactivated rabies virus) is approved to treat rabies.
  • Livtencity

    Livtencity (maribavir) is approved to treat cytomegalovirus (CMV).
  • Camzyos

    Camzyos (mavacamten) is approved to treat cardiomyopathy.
  • Trecondi

    Trecondi (treosulfan) is approved to treat cancer
  • Xembify

    TGA decision: Xembify (normal immunoglobulin human) is approved to treat primary immunodeficiency diseases (PID).
  • Padcev

    Padcev (enfortumab vedotin) is approved to treat adult patients with locally advanced or metastatic urothelial cancer.
  • Scemblix

    Scemblix (asciminib) is approved to treat Philadelphia chromosome-positive chronic myeloid leukaemia.
  • Trastucip and Tuzucip

    TGA decision: Trastucip and Tuzucip (trastuzumab) are approved to treat breast cancer.

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