Canada - English - Health Canada

apotex inc - erlotinib (erlotinib hydrochloride) - tablet - 150mg - erlotinib (erlotinib hydrochloride) 150mg - antineoplastic agents

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

intega sdn. bhd. - erlotinib hydrochloride -

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

intega sdn. bhd. - erlotinib hydrochloride -

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

physicians total care, inc. - erlotinib hydrochloride (unii: da87705x9k) (erlotinib - unii:j4t82ndh7e) - erlotinib 25 mg - enter section text here tarceva monotherapy 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 [see clinical studies (14.1)]. results from two, multicenter, placebo-controlled, randomized, phase 3 trials conducted in first-line patients with locally advanced or metastatic nsclc showed no clinical benefit with the concurrent administration of tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting [see clinical studies (14.3)]. tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see clinical studies (14.3)]. none. pregnancy category d [see warnings and precautions (5.8) ] erlotinib has been shown to cause maternal toxicity with associated embryo/fetal lethality and abortion in rabbits when given at dose

New Zealand - English - Medsafe (Medicines Safety Authority)

multichem nz limited - erlotinib hydrochloride 109.267mg equivalent to erlotinib 100mg - film coated tablet - 100 mg - active: erlotinib hydrochloride 109.267mg equivalent to erlotinib 100mg excipient: opadry white 20b58900 lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate sodium starch glycolate - · 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)

multichem nz limited - erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg - film coated tablet - 150 mg - active: erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg excipient: opadry white 20b58900 lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate sodium starch glycolate - · 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)

multichem nz limited - erlotinib hydrochloride 27.317mg equivalent to erlotinib 25mg - film coated tablet - 25 mg - active: erlotinib hydrochloride 27.317mg equivalent to erlotinib 25mg excipient: opadry white 20b58900 lactose monohydrate magnesium stearate microcrystalline cellulose sodium laurilsulfate sodium starch glycolate - · 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 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.