Australian Public Assessment Reports (AusPAR)

Omvoh (mirikizumab) has been approved for the treatment of moderately to severely active ulcerative colitis in adult patients

Veoza (fezolinetant) has been approved for the treatment of moderate to severe hot flashes associated with menopause

Beyfortus (nirsevimab) has been approved for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. It is also for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Tibsovo (ivosidenib) has been approved for the treatment of acute myeloid leukaemia in adults with an isocitrate dehydrogenase-1 (IDH1) mutation

Melatonin-Link, Immela, Melakso, Voquily (melatonin) has been approved for short-term treatment of jet lag in adults aged 18 and over, and for sleep disorders in children and adolescents with neurodevelopmental disorders.

Alhemo (concizumab) is approved to prevent or reduce frequency of bleeding in patients who have haemophilia B with FIX inhibitors.

Exarane/Exarane Forte (enoxaparin sodium) has been approved for the prevention of thrombo-embolic disorders, thrombosis and prophylaxis of venous thromboembolism. It has also been approved for the treatment of deep vein thrombosis, unstable angina, non-Q-wave myocardial infarction and acute ST-segment elevation myocardial infarction.

Nurtec ODT (rimegepant) has been approved for the treatment of acute migraine and the prophylactic treatment of episodic migraine in adults

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.