Israel - English - Ministry of Health

teva israel ltd - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 100 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib teva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib teva is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy. erlotinib teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer: erlotinib teva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Israel - English - Ministry of Health

teva israel ltd - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 150 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib teva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib teva is indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations and stable disease after first-line chemotherapy. erlotinib teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.pancreatic cancer: erlotinib teva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - erlotinib hydrochloride 109.28mg equivalent to erlotinib 100mg - film coated tablet - 100 mg - active: erlotinib hydrochloride 109.28mg equivalent to erlotinib 100mg excipient: colloidal silicon dioxide lactose microcrystalline cellulose opadry white 03f180011 purified water sodium laurilsulfate sodium starch glycolate sodium stearyl fumarate - · erlotinib is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. · erlotinib is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) who have previously received chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg - film coated tablet - 150 mg - active: erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg excipient: colloidal silicon dioxide lactose microcrystalline cellulose opadry white 03f180011 purified water sodium laurilsulfate sodium starch glycolate sodium stearyl fumarate - · erlotinib is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. · erlotinib is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) who have previously received chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

teva pharma (new zealand) limited - erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg - film coated tablet - 25 mg - active: erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg excipient: colloidal silicon dioxide lactose microcrystalline cellulose opadry white 03f180011 purified water sodium laurilsulfate sodium starch glycolate sodium stearyl fumarate - · erlotinib is indicated for the first-line and maintenance treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations. · erlotinib is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer (nsclc) who have previously received chemotherapy.

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - erlotinib hydrochloride (unii: da87705x9k) (erlotinib - unii:j4t82ndh7e) - erlotinib tablets are indicated for: - the treatment of patients with metastatic non-small cell lung cancer (nsclc) whose tumors have epidermal growth factor receptor (egfr) exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see clinical studies (14.1, 14.3)] . limitations of use: - safety and efficacy of erlotinib tablets have not been established in patients with nsclc whose tumors have other egfr mutations [see clinical studies (14.1, 14.2 )]. - erlotinib tablets are not recommended for use in combination with platinum-based chemotherapy [see clinical studies (14.4)] . erlotinib tablets in combination with gemcitabine are indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see clinical studies (14.5) ]. none. risk summary based on animal data and its mec

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - erlotinib hydrochloride - oral tablet - 150mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - erlotinib hydrochloride - oral tablet - 100mg

Canada - English - Health Canada

teva canada limited - erlotinib (erlotinib hydrochloride) - tablet - 25mg - erlotinib (erlotinib hydrochloride) 25mg - antineoplastic agents

Canada - English - Health Canada

teva canada limited - erlotinib (erlotinib hydrochloride) - tablet - 100mg - erlotinib (erlotinib hydrochloride) 100mg - antineoplastic agents