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

roche products pty ltd - entrectinib, quantity: 200 mg - capsule, hard - excipient ingredients: propylene glycol; indigo carmine aluminium lake; magnesium stearate; hypromellose; lactose; shellac; sunset yellow fcf; tartaric acid; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; titanium dioxide; strong ammonia solution - non-small cell lung cancer (nsclc),rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) whose tumours are ros1-positive. solid tumours,rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with 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 have no satisfactory alternative therapy.,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

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

roche products pty ltd - entrectinib, quantity: 100 mg - capsule, hard - excipient ingredients: magnesium stearate; tartaric acid; strong ammonia solution; crospovidone; shellac; iron oxide yellow; lactose; colloidal anhydrous silica; titanium dioxide; hypromellose; propylene glycol; microcrystalline cellulose; indigo carmine aluminium lake - non-small cell lung cancer (nsclc),rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (nsclc) whose tumours are ros1-positive. solid tumours,rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with 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 have no satisfactory alternative therapy.,this indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

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

trek mobility products pty ltd - 45684 - assistive scooter, electric-motor-driven - a battery powered, motor driven mobility device designed to be operated by a person with a disability.

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

trek mobility products pty ltd - 45684 - assistive scooter, electric-motor-driven - a motorised mobility aid with seat operated by means of a joy stick or throttle lever.

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

trek mobility products pty ltd -

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

trek mobility products pty ltd -

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - entrectinib 100mg;   - capsule - 100 mg - active: entrectinib 100mg   excipient: colloidal silicon dioxide crospovidone hypromellose     iron oxide yellow   lactose magnesium stearate microcrystalline cellulose tartaric acid tekprint blue sb-6018 titanium dioxide   - solid tumours rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (ntrk) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. this indication was approved based on objective response rate and response duration in single-arm trials. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. non-small cell lung cancer (nsclc) rozlytrek is indicated for the treatment of adult patients with ros1-positive, locally advanced or metastatic nsclc.

New Zealand - English - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - entrectinib 200mg;   - capsule - 200 mg - active: entrectinib 200mg   excipient: colloidal silicon dioxide crospovidone hypromellose     lactose magnesium stearate microcrystalline cellulose sunset yellow aluminium lake   tartaric acid tekprint blue sb-6018 titanium dioxide   - solid tumours rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (ntrk) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. this indication was approved based on objective response rate and response duration in single-arm trials. continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. non-small cell lung cancer (nsclc) rozlytrek is indicated for the treatment of adult patients with ros1-positive, locally advanced or metastatic nsclc.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - entrectinib - hard capsule - entrectinib 100 mg - entrectinib - rozlytrek is indicated for the treatment of adults with solid tumors 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 have no satisfactory alternative therapy.rozlytrek is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are ros1-positive.

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - entrectinib - hard capsule - entrectinib 200 mg - entrectinib - rozlytrek is indicated for the treatment of adults with solid tumors 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 have no satisfactory alternative therapy.rozlytrek is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are ros1-positive.