Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 150 mg - tablet, film coated - excipient ingredients: silicon dioxide; sodium lauryl sulfate; hypromellose acetate succinate; magnesium stearate; croscarmellose sodium; carnauba wax; microcrystalline cellulose; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - trikafta 100/50/75 is indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - tezacaftor, quantity: 100 mg; ivacaftor, quantity: 150 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; hypromellose; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; hyprolose; purified talc; iron oxide yellow - symdeko is indicated for the treatment of patients with cystic fibrosis (cf) aged 6 years and older who are homozygous for the f508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.,refer to table 1 for a list of responsive mutations.

Australia - English - Department of Health (Therapeutic Goods Administration)

merck healthcare pty ltd - tepotinib hydrochloride monohydrate, quantity: 250 mg (equivalent: tepotinib, qty 225 mg) - tablet, film coated - excipient ingredients: mannitol; crospovidone; magnesium stearate; colloidal anhydrous silica; hypromellose; titanium dioxide; lactose monohydrate; macrogol 3350; triacetin; iron oxide red; microcrystalline cellulose - tepmetko has provisional approval in australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harbouring mesenchymal-epithelial transition (met) exon 14 skipping alterations.,the decision to approve this indication has been made on the basis of overall response rate (orr) and duration of response (dor). continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

Australia - English - Department of Health (Therapeutic Goods Administration)

clinect pty ltd - telotristat etiprate, quantity: 327.9 mg (equivalent: telotristat ethyl, qty 250 mg) - tablet, film coated - excipient ingredients: hyprolose; colloidal anhydrous silica; lactose; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - xermelo is indicated for the treatment of carcinoid syndrome diarrhoea in combination with somatostatin analog (ssa) therapy in adults inadequately controlled by ssa therapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - tafenoquine succinate, quantity: 188.2 mg - tablet, film coated - excipient ingredients: magnesium stearate; mannitol; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - tafenoquine is indicated, in combination with chloroquine, for the radical cure (prevention of relapse) of plasmodium vivax (p. vivax) malaria (see section 4.2 dose and method of administration).

Australia - English - Department of Health (Therapeutic Goods Administration)

biocelect pty ltd - tafenoquine succinate, quantity: 125.5 mg - tablet, film coated - excipient ingredients: magnesium stearate; mannitol; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - malaria prophylaxis kodatef (tafenoquine) is an antimalarial indicated for the prevention of malaria in adults 18 years of age and above for up to 6 months of continuous dosing.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - tafamidis, quantity: 61 mg - capsule, soft - excipient ingredients: macrogol 400; povidone; butylated hydroxytoluene; polysorbate 20; purified water; iron oxide red; sorbitol; gelatin; glycerol; titanium dioxide; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; polyvinyl acetate phthalate - vyndamax is indicated for the treatment of adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (attr-cm).

Australia - English - Department of Health (Therapeutic Goods Administration)

glaxosmithkline australia pty ltd - sotrovimab, quantity: 500 mg - injection, concentrated - excipient ingredients: water for injections; histidine hydrochloride monohydrate; histidine; polysorbate 80; methionine; sucrose - xevudy has provisional approval for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (covid-19) who do not require initiation of oxygen due to covid-19 and who are at increased risk of progression to hospitalisation or death (see section 5.1 pharmacodynamic properties, clinical trials).,the decision has been made on the basis of short term efficacy and safety data. continued approval of this indication depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

Australia - English - Department of Health (Therapeutic Goods Administration)

amgen australia pty ltd - sotorasib, quantity: 120 mg - tablet, film coated - excipient ingredients: purified water; microcrystalline cellulose; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - lumakras has provisional approval in australia for the treatment of adult patients with kras g12c-mutated locally advanced or metastatic non-small cell lung cancer (nsclc) who have received at least one prior systemic therapy for advanced disease.,the decision to approve this indication has been made on the basis of the objective response rate (orr) and the duration of response (dor). continued approval of this indication depends on the verification and description of benefit in confirmatory trials.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - somatrogon, quantity: 50 mg/ml - injection, solution - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; histidine; sodium chloride; metacresol; poloxamer; water for injections - long term treatment of paediatric patients with growth disturbance due to insufficient secretion of growth hormone.