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

accelagen pty ltd - sunitinib malate, quantity: 66.824 mg (equivalent: sunitinib, qty 50 mg) - capsule, hard - excipient ingredients: iron oxide black; gelatin; iron oxide red; mannitol; iron oxide yellow; pregelatinised maize starch; titanium dioxide; magnesium stearate; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

accelagen pty ltd - sunitinib malate, quantity: 66.824 mg (equivalent: sunitinib, qty 50 mg) - capsule, hard - excipient ingredients: iron oxide red; iron oxide black; titanium dioxide; gelatin; mannitol; croscarmellose sodium; magnesium stearate; iron oxide yellow; pregelatinised maize starch; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

accelagen pty ltd - sunitinib malate, quantity: 33.412 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: titanium dioxide; gelatin; iron oxide red; mannitol; croscarmellose sodium; magnesium stearate; pregelatinised maize starch; iron oxide black; iron oxide yellow; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

accelagen pty ltd - sunitinib malate, quantity: 16.706 mg (equivalent: sunitinib, qty 12.5 mg) - capsule, hard - excipient ingredients: magnesium stearate; mannitol; titanium dioxide; croscarmellose sodium; gelatin; pregelatinised maize starch; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

accelagen pty ltd - sunitinib malate, quantity: 33.412 mg (equivalent: sunitinib, qty 25 mg) - capsule, hard - excipient ingredients: iron oxide yellow; mannitol; croscarmellose sodium; titanium dioxide; iron oxide red; gelatin; pregelatinised maize starch; magnesium stearate; iron oxide black; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; shellac; ethanol absolute; ammonia; potassium hydroxide - sunitinib msn is indicated for;,treatment of advanced renal cell carcinoma (rcc),treatment of gastrointestinal stromal tumour (gist) after failure of imatinib mesilate treatment due to resistance or intolerance,treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic net)

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

bayer australia ltd - larotrectinib sulfate, quantity: 30.7 mg - capsule, hard - excipient ingredients: gelatin; propylene glycol; dimethicone 12500; brilliant blue fcf aluminium lake; titanium dioxide; shellac; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate dihydrate; hydroxypropylbetadex; purified water; flavour; sorbitol; methyl hydroxybenzoate; citric acid; sucrose; glycerol; monobasic sodium phosphate; potassium sorbate - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 24.6 mg/ml - oral liquid, solution - excipient ingredients: sodium citrate; hydroxypropylbetadex; purified water; sucralose; sodium benzoate; citric acid; flavour - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

bayer australia ltd - larotrectinib sulfate, quantity: 122.9 mg - capsule, hard - excipient ingredients: titanium dioxide; shellac; gelatin; dimethicone 12500; propylene glycol; brilliant blue fcf aluminium lake; strong ammonia solution - vitrakvi (larotrectinib) has provisional approval in australia for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours that:,? have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion without a known acquired resistance mutation, ? are metastatic or where surgical resection is likely to result in severe morbidity, and ? have either progressed following treatment or who have no satisfactory alternative therapy. the decision to approve this indication has been made on the basis of objective response rate (orr) and duration of response from single arm clinical studies. the sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

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

inova pharmaceuticals (australia) pty ltd - fluorouracil, quantity: 50 mg/g - cream - excipient ingredients: methyl hydroxybenzoate; propyl hydroxybenzoate; polysorbate 60; white soft paraffin; purified water; propylene glycol; stearyl alcohol - indications as at 30 july 1990: solar and senile keratoses, bowen's disease.