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

dr reddys laboratories australia pty ltd - quetiapine fumarate, quantity: 345.396 mg (equivalent: quetiapine, qty 300 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; povidone; calcium hydrogen phosphate dihydrate; sodium starch glycollate type a; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 400 - bipolar disorder. adults = maintenance treatment of bipolar i disorder, as monotherapy, or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. = treatment of depressive episodes associated with bipolar disorder (see dosage and administration). = treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.,children/adolescents aged 10 to 17 years,= monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia. (adults and adolescents aged 13 to 17 years) = treatment of schizophrenia.

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

dr reddys laboratories australia pty ltd - quetiapine fumarate, quantity: 230.264 mg (equivalent: quetiapine, qty 200 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; lactose monohydrate; calcium hydrogen phosphate dihydrate; povidone; titanium dioxide; hypromellose; macrogol 400 - bipolar disorder. adults = maintenance treatment of bipolar i disorder, as monotherapy, or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. = treatment of depressive episodes associated with bipolar disorder (see dosage and administration). = treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.,children/adolescents aged 10 to 17 years,= monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia. (adults and adolescents aged 13 to 17 years) = treatment of schizophrenia.

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

dr reddys laboratories australia pty ltd - quetiapine fumarate, quantity: 115.132 mg (equivalent: quetiapine, qty 100 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; calcium hydrogen phosphate dihydrate; povidone; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - bipolar disorder. adults = maintenance treatment of bipolar i disorder, as monotherapy, or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. = treatment of depressive episodes associated with bipolar disorder (see dosage and administration). = treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.,children/adolescents aged 10 to 17 years,= monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia. (adults and adolescents aged 13 to 17 years) = treatment of schizophrenia.

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

dr reddys laboratories australia pty ltd - quetiapine fumarate, quantity: 28.783 mg (equivalent: quetiapine, qty 25 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate type a; microcrystalline cellulose; lactose monohydrate; magnesium stearate; calcium hydrogen phosphate dihydrate; colloidal anhydrous silica; povidone; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400 - bipolar disorder. adults = maintenance treatment of bipolar i disorder, as monotherapy, or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. = treatment of depressive episodes associated with bipolar disorder (see dosage and administration). = treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.,children/adolescents aged 10 to 17 years,= monotherapy treatment of acute mania associated with bipolar i disorder,schizophrenia. (adults and adolescents aged 13 to 17 years) = treatment of schizophrenia.

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

ranbaxy australia pty ltd - risperidone -

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

ranbaxy australia pty ltd - topiramate -