Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - erlotinib hydrochloride 163,9 mg - eq. erlotinib 150 mg - film-coated tablet - 150 mg - erlotinib hydrochloride 163.9 mg - erlotinib

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

zydus 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 i

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

teva uk ltd - erlotinib hydrochloride - oral tablet - 25mg

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - erlotinib hydrochloride, quantity: 109.267 mg (equivalent: erlotinib, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. erlotinib cipla is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - erlotinib hydrochloride, quantity: 163.9 mg (equivalent: erlotinib, qty 150 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. erlotinib cipla is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - erlotinib hydrochloride, quantity: 27.317 mg (equivalent: erlotinib, qty 25 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfr mutations who have not progressed on first-line chemotherapy. erlotinib cipla is also indicated for the treatment of patients with locally advanced or metastatic non small cell lung cancer after failure of prior chemotherapy.,pancreatic cancer erlotinib cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

aurobindo pharma 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 tablets 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 o

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