Australian Public Assessment Reports (AusPAR)

Rystiggo has been approved as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

TALVEY (talquetamab) has been provisionally approved for the treatment of adult patients with relapsed or refractory multiple myeloma.

CLASTO, ENOXACOR and ENOXAJECT (enoxaparin sodium) is a biosimilar to CLEXANE, an anticoagulant medication approved for multiple uses.

JOENJA (Leniolisib) is for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older

EPKINLY (epcoritamab) has been provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

VISTELLA (calcifediol) is for the treatment or prevention of vitamin D deficiency in adults.

FABHALTA (iptapocan) is for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

ZILBRYSQ (zilucoplan) is an add-on to standard therapy for the treatment of generalised myasthenia gravis in adult patients who are anti-acetylcholine receptor-antibody positive.

AWIQLI (insulin icodec) has been approved for the treatment, in adults, of type 2 diabetes and type 1 diabetes in conjunction with a bolus insulin, where daily basal insulin injections are not suitable.

Daxxify (daxibotulinumtoxinA) is for use in adults for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity and for the treatment of cervical dystonia.

Opsynvi (macitentan/tadalafil) is approved for maintenance treatment of pulmonary arterial hypertension in adult patients.

Litfulo (ritlecitinib) has been approved for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

Andembry was approved for the prevention of recurrent hereditary angioedema (HAE) attacks in patients aged 12 years and older with C1-INH HAE (C1-esterase inhibitor deficiency or dysfunction).

Oxlumo (lumasiran) has been approved for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.

Pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat which has been approved for the treatment of adults with late onset Pompe disease (acid α-glucosidase [GAA] deficiency).

Kisunla (donanemab) has been approved for the treatment of patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia (early symptomatic Alzheimer’s disease) that have only one or no copies of the apolipoprotein E ε4 (ApoE ε4) gene.

Voranigo (vorasidenib) was approved for the treatment of certain types of brain tumours (astrocytomas or oligodendrogliomas).

mRESVIA is a vaccine that was approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

The Comirnaty JN.1 vaccine (Bretovameran), adapted to the SARS-CoV-2 Omicron JN.1 strain, has been approved to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 6 months of age and older.

Eladynos (abaloparatide) has been approved for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Columvi (glofitamab), with obinutuzumab pretreatment, was provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi is not indicated for the treatment of patients with primary central nervous system lymphoma.

Truqap (capivasertib), in combination with fulvestrant, was approved for the treatment of adult patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine-based regimen.

Gazyva (obinutuzumab) was approved as a pre-treatment to reduce the risk of cytokine release syndrome (CRS) induced by glofitamab.

Verdye (indocyanine green) is a non-toxic medical dye that is injected intravenously and is used to measure certain cardiac, circulatory and liver functions. This medicinal product is for diagnostic use only.