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

alembic pharmaceuticals 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 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

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

alembic pharmaceuticals 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 tablets are 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

Singapore - English - HSA (Health Sciences Authority)

intega pte ltd - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 100.00mg

Singapore - English - HSA (Health Sciences Authority)

intega pte ltd - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 150.00mg

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

Canada - English - Health Canada

teva canada limited - erlotinib (erlotinib hydrochloride) - tablet - 150mg - erlotinib (erlotinib hydrochloride) 150mg - antineoplastic agents

Canada - English - Health Canada

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

Canada - English - Health Canada

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

Canada - English - Health Canada

natco pharma (canada) inc - erlotinib (erlotinib hydrochloride) - tablet - 25mg - erlotinib (erlotinib hydrochloride) 25mg - antineoplastic agents