Australian Public Assessment Reports (AusPAR)

Retevmo (selpercatinib) is provisionally approved for the treatment of adults with locally advanced or metastatic RET fusion positive non-small cell lung cancer.

Sunlenca (Lenacapavir) has been approved to treat adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Opdualag (Nivolumab and Relatlimab) has been approved for the treatment of patients with unresectable or metastatic melanoma who are at least 12 years old.

Imfinzi (Durvalumab) has been approved for the treatment of unresectable hepatocellular carcinoma.

Imjudo (tremelimumab) is approved for the treatment of unresectable hepatocellular carcinoma.

Andexxa (andexanet alfa) is provisionally approved for adult patients treated with a direct factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Letybo (letibotulinumtoxinA) has been approved for temporary improvement in the appearance of glabellar frown lines in adults.

Mounjaro (tirzepatide) is approved for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise.

Jivi (damoctocog alfa pegol) has been approved for the prevention or treatment of bleeding in previously treated adults and adolescents with haemophilia A.

Korsuva (difelikefalin) is approved to treat moderate-to-severe pruritus associated with chronic kidney disease in adults on haemodialysis.

Nuvaxovid (SARS-CoV-2-rS), a vaccine against SARS-CoV-2, has been approved for the prevention of COVID-19.

Intrarosa (prasterone) has been approved for the treatment of vulvar and vaginal atrophy.

Flucelvax Quad (Influenza virus haemagglutinin), a vaccine for the prevention of influenza caused by Influenza Virus Types A and B , has been approved.

Gavreto (pralsetinib) has been approved for the treatment of adult patients with advanced or metastatic RET-fusion positive thyroid cancer.

Esperoct (turoctocog alfa pegol) has been approved to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A.

Gavreto (pralsetinib) has been approved for the treatment of locally advanced or metastatic RET fusion-positive non-small cell lung cancer.

Teriparatide Lupin/ Teriparatide LAPL/ Teriparatide GH (teriparatide) has been approved for the treatment of osteoporosis.

Spikevax XBB.1.5 (andusomeran) has been approved for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

Tavneos (avacopan), in combination with a rituximab- or cyclophosphamide-based regimen, has been approved for the treatment of anti-neutrophil cytoplasmic autoantibody-associated vasculitis

Tibsovo (Ivosidenib) has been approved for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) R132 mutation after at least one prior line of systemic therapy.

Nuceiva (prabotulinum toxin A) is indicated for the temporary improvement in appearance of glabellar lines.

WELIREG (belzutifan) is indicated for treatment of patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system haemangioblastomas, or pancreatic neuroendocrine tumours, not requiring immediate surgery.

Vazkepa (icosapent ethyl) has been approved for the reduction of the incidence of cardiovascular events in adults.

Comirnaty (tozinameran), a vaccine, has been approved for the prevention of coronavirus disease 2019 (COVID-19) in individuals 12 years of age and older.

Withdrawn submission related to AusPAR for MVC COVID-19 Vaccine, for the prevention of novel coronavirus disease (COVID-19).