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Australian prescription medicine decision summaries

Search our decision summaries for the registration of new prescription medicines.

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

We have redesigned our prescription medicine decision summaries (AusPMDSs) to make it easier to understand how prescription medicines are registered in Australia. 

The redesigned AusPMDSs will offer clear, accessible information about recent medicine registration decisions.

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245 result(s) found, displaying 76 to 100
  • ​TGA decision: Intrarosa (prasterone) is approved to treat vulvar and vaginal atrophy in postmenopausal women.
  • ​TGA decision: Esperoct (turoctocog alfa pegol) is approved to treat haemophilia A.
  • TGA decision: Gavreto (pralsetinib) is provisionally approved to treat adults with advanced or metastatic rearranged during transfection- fusion positive thyroid cancer.
  • TGA decision: Tibsovo (ivosidenib) is approved to treat cancer.
  • 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.
  • TGA decision: Jivi (damoctocog alfa pegol) is approved to treat adults and adolescents (12 years of age and older) with haemophilia A
  • TGA decision: Sunlenca (lenacapavir sodium) is approved to treat multidrug resistant HIV-1 infection.
  • TGA decision: Radicava (edaravone) is approved to treat adults with a diagnosis of amyotrophic lateral sclerosis.
  • Nuceiva (prabotulinumtoxinA) is approved to treat glabellar lines.
  • Doptelet (avatrombopag maleate) is approved to treat thrombocytopenia in adult patients.
  • Mounjaro (tirzepatide) is approved to treat diabetes.
  • Welireg (belzutifan) is approved to treat adult patients with von Hippel-Lindau (VHL) disease
  • Evusheld (tixagevimab and cilgavimab) is approved to treat COVID-19
  • TGA decision: Prevenar 20 (Pneumococcal purified capsular polysaccharides) is approved to prevent pneumococcal disease.
  • TGA decision: Rybrevant (amivantamab) is approved to treat lung cancer
  • Sotyktu (deucravacitinib) is approved to treat plaque psoriasis.
  • TGA decision: Letybo (letibotulinumtoxinA) is approved to treat the appearance of moderate to severe glabellar frown lines in adults.
  • Onpattro (patisiran) is approved to treat polyneuropathy.
  • Korsuva (difelikefalin acetate) is approved to treat chronic kidney disease
  • Vazkepa (Icosapent ethyl) is approved to treat cardiovascular disease.
  • Vabysmo (faricimab) is approved to treat macular degeneration.