ישראל - אנגלית - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - erlotinib hydrochloride - film coated tablets - erlotinib hydrochloride 100 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib s.k. is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib s.k. 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. erlotinib s.k. 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: erlotinib s.k. is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

ישראל - אנגלית - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - erlotinib hydrochloride - film coated tablets - erlotinib hydrochloride 25 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib s.k. is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib s.k. 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. erlotinib s.k. 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: erlotinib s.k. is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - erlotinib (unii: j4t82ndh7e) (erlotinib - unii:j4t82ndh7e) - erlotinib tablets are indicated for: 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. 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 2-4% and 15-20%, respectively. erlotinib has been shown to cause maternal toxicity resulting in embryo-fetal let

ארצות הברית - אנגלית - NLM (National Library of Medicine)

mylan institutional inc. - erlotinib (unii: j4t82ndh7e) (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)] . - 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,

ישראל - אנגלית - 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.

ישראל - אנגלית - 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.

ישראל - אנגלית - Ministry of Health

teva israel ltd - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 25 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib teva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with egfr activating mutations. erlotinib teva 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. erlotinib teva 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: erlotinib teva is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

מלטה - אנגלית - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 25 mg - antineoplastic agents

מלטה - אנגלית - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 100 mg - antineoplastic agents

מלטה - אנגלית - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 150 mg - antineoplastic agents