Australian Public Assessment Reports (AusPAR)

Vegzelma (bevacizumab), in combination with fluoropyrimidine-based chemotherapy, has been approved for the treatment of metastatic colorectal cancer.

MS-2 Step (mifepristone & misoprostol composite pack) Product Information and Risk Management Plan changes were approved.

Comirnaty Omicron XBB.1.5 (raxtozinameran) COVID-19 vaccine has been approved for the prevention of COVID-19 in individuals 6 months to 12 years old.

Doptelet (avatrombopag) has been approved for the treatment of thrombocytopenia in adult patients with chronic liver disease and chronic immune thrombocytopenia.

Comirnaty Original/Omicron BA.4-5 (tozinameran/famtozinameran) is provisionally approved to prevent COVID-19 in individuals 5 years of age and older.

Minjuvi (tafasitamab) is provisionally approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplants.

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