USA - engelsk - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - 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 tablet is not recommended for use in combination with platinum-based chemotherapy [see clinical studies (14.4)]. erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see clinical studies (14.5)]. none. risk summary based on animal data and its mechanism of

USA - engelsk - NLM (National Library of Medicine)

msn laboratories private limited - 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 tablet is not recommended for use in combination with platinum-based chemotherapy [see clinical studies (14.4)]. erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see clinical studies (14.5)]. none. risk summary based on animal data and its mechanism of

Malta - engelsk - Malta Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 150 mg - antineoplastic agents

Malta - engelsk - Malta Medicines Authority

jv healthcare limited navi buidlings, pantar road, lija, lja 2021, malta - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 150 mg - antineoplastic agents

Japan - engelsk - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - erlotinib hydrochloride - white to yellowish white tablet (diameter: 9.6mm, thickness: 5.0mm)

Japan - engelsk - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - erlotinib hydrochloride - white to yellowish white tablet (diameter: 6.5mm, thickness: 3.2mm)

Canada - engelsk - Health Canada

apotex inc - erlotinib (erlotinib hydrochloride) - tablet - 25mg - erlotinib (erlotinib hydrochloride) 25mg - antineoplastic agents

Canada - engelsk - Health Canada

apotex inc - erlotinib (erlotinib hydrochloride) - tablet - 100mg - erlotinib (erlotinib hydrochloride) 100mg - antineoplastic agents

Canada - engelsk - Health Canada

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

USA - engelsk - 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