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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg - film coated tablet - 25 mg - active: erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opadry white 200f280000 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 nsclc who have previously received chemotherapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg - film coated tablet - 50 mg - active: erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg excipient: lactose monohydrate magnesium stearate microcrystalline cellulose opadry white 200f280000 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 nsclc who have previously received chemotherapy.

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

Israel - English - Ministry of Health

roche pharmaceuticals (israel) ltd - erlotinib as dihydrochloride - film coated tablets - erlotinib as dihydrochloride 150 mg - erlotinib - erlotinib - non-small cell lung cancer (nsclc):tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations.tarceva 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.tarceva 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:tarceva 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

roche pharmaceuticals (israel) ltd - erlotinib as dihydrochloride - film coated tablets - erlotinib as dihydrochloride 100 mg - erlotinib - erlotinib - non-small cell lung cancer (nsclc):tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations.tarceva 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.tarceva 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:tarceva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

breckenridge pharmaceutical, 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 mechanis

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

sun pharmaceutical industries, inc. - erlotinib (unii: j4t82ndh7e) (erlotinib - unii:j4t82ndh7e) - erlotinib tablets are indicated for: limitations of use: 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 mechanism of action, erlotinib can cause fetal harm when administered to a pregnant woman. limited available data on use of erlotinib in pregnant women are not sufficient to inform a risk of major birth defects or miscarriage. when given during organogenesis, erlotinib administration resulted in embryo-fetal lethality and abortion in rabbits at exposures approximately 3 times the exposure at the recommended human daily dose of 150 mg. advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data erlotinib has been shown

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

armas pharmaceuticals inc. - erlotinib hydrochloride (unii: da87705x9k) (erlotinib - unii:j4t82ndh7e) - erlotinib tablets was 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 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 based on animal data and its mechanism of action, erlotinib tablets