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.

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.

Bangladesh - English - DGDA (Directorate General of Drug Administration)

beacon pharmaceuticals plc - entrectinib - capsule - 200 mg

European Union - English - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastic agents - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing 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 not received a prior ntrk inhibitorwho have no satisfactory treatment options.rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - entrectinib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

roche (malaysia) sdn. bhd. - entrectinib -

Canada - English - Health Canada

hoffmann-la roche limited - entrectinib - capsule - 100mg - entrectinib 100mg - antineoplastic agents

Canada - English - Health Canada

hoffmann-la roche limited - entrectinib - capsule - 200mg - entrectinib 200mg - antineoplastic agents