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.

Israel - English - Ministry of Health

bayer israel ltd - larotrectinib as sulfate - solution (oral) - larotrectinib as sulfate 20 mg/ml - larotrectinib - vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,• who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and• who have no satisfactory treatment options

Israel - English - Ministry of Health

bayer israel ltd - larotrectinib as sulfate - capsules - larotrectinib as sulfate 100 mg - larotrectinib - vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (ntrk) gene fusion:• who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and• who have no satisfactory treatment options

Israel - English - Ministry of Health

bayer israel ltd - larotrectinib as sulfate - capsules - larotrectinib as sulfate 25 mg - larotrectinib - vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (ntrk) gene fusion:• who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and• who have no satisfactory treatment options

European Union - English - EMA (European Medicines Agency)

bayer ag - larotrectinib sulfate - abdominal neoplasms - antineoplastic agents - vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have no satisfactory treatment options.

Canada - English - Health Canada

bayer inc - larotrectinib (larotrectinib sulfate) - capsule - 25mg - larotrectinib (larotrectinib sulfate) 25mg - antineoplastic agents

Canada - English - Health Canada

bayer inc - larotrectinib (larotrectinib sulfate) - capsule - 100mg - larotrectinib (larotrectinib sulfate) 100mg - antineoplastic agents