Australian Public Assessment Reports (AusPAR)

Xeomin (incobotulinumtoxinA) has been approved for the treatment of chronic sialorrhea (hypersalivation or excessive drooling) in children and adults.

Aquipta (atogepant) has been approved for the prophylaxis of migraine in adults who have at least four migraine days per month

Wezlana (ustekinumab) has been approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Raniviz (ranibizumab) has been approved for the treatment of neovascular age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, choroidal neovascularisation and macular oedema.

Nuvaxovid (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 vaccine has been approved for the prevention of coronavirus disease 2019 (COVID-19) caused by SARSCoV-2 in individuals 12 years of age and older.

Adcetris (brentuximab vedotin) has been approved for the treatment of Hodgkin lymphoma in patients with previously untreated CD30+ Stage III or Stage IV Hodgkin lymphoma.

Idefirix (imlifidase) has been approved for the desensitisation treatment of highly sensitised adult kidney transplant candidates prior to kidney transplantation

Onbevzi (bevacizumab) is a biosimilar of Avastin. Onbevzi has been approved to treat a range of cancers either as a monotherapy or in combination with other anti-cancer medicines

Abrysvo is a vaccine that provides active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).

Tecvayli (teclistamab) has been provisionally approved for the treatment of relapsed or refractory multiple myeloma in adult patients.

Arexvy is a vaccine approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years and older

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.