Inggris - Inggris - MHRA (Medicines & Healthcare Products Regulatory Agency)

sandoz ltd - erlotinib hydrochloride - oral tablet - 100mg

Amerika Serikat - Inggris - 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

Amerika Serikat - Inggris - 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,

Amerika Serikat - Inggris - 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

Israel - Inggris - Ministry of Health

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

Israel - Inggris - Ministry of Health

taro international ltd, israel - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 150 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib taro 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 taro 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 taro 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 taro is indicated in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Israel - Inggris - Ministry of Health

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

Israel - Inggris - Ministry of Health

k.s.kim international (sk- pharma) ltd., israel - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 150 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.

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 109.27mg equivalent to erlotinib 100mg - film coated tablet - 100 mg - active: erlotinib hydrochloride 109.27mg equivalent to erlotinib 100mg 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.

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg - film coated tablet - 150 mg - active: erlotinib hydrochloride 163.9mg equivalent to erlotinib 150mg 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.