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

eg sa-nv - erlotinib hydrochloride 109,27 mg - eq. erlotinib 100 mg - film-coated tablet - 100 mg - erlotinib hydrochloride 109.27 mg - erlotinib

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

sandoz sa-nv - erlotinib hydrochloride 109,27 mg - eq. erlotinib 100 mg - film-coated tablet - 100 mg - erlotinib hydrochloride 109.27 mg - erlotinib

Malta - English - Medicines Authority

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

Malta - English - Medicines Authority

pharmascience international ltd lampousas 1, 1095 nicosia , cyprus - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 100 mg - antineoplastic agents

Singapore - English - HSA (Health Sciences Authority)

roche singapore pte. ltd. - erlotinib hydrochloride eqv. erlotinib - tablet, film coated - 100mg - erlotinib hydrochloride eqv. erlotinib 100mg

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

accelagen pty ltd - erlotinib hydrochloride, quantity: 109.267 mg (equivalent: erlotinib, qty 100 mg) - tablet, film coated - excipient ingredients: titanium dioxide; magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; hypromellose; sodium lauryl sulfate; sodium starch glycollate - non-small cell lung cancer,erlotinib arx is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations.,erlotinib arx is indicated for maintenance 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 arx 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 arx 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)

accelagen pty ltd - erlotinib hydrochloride, quantity: 163.9 mg (equivalent: erlotinib, qty 150 mg) - tablet, film coated - excipient ingredients: titanium dioxide; sodium starch glycollate; lactose monohydrate; magnesium stearate; hyprolose; propylene glycol; microcrystalline cellulose; hypromellose; sodium lauryl sulfate - non-small cell lung cancer,erlotinib arx is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations.,erlotinib arx is indicated for maintenance 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 arx 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 arx 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)

accelagen pty ltd - erlotinib hydrochloride, quantity: 27.317 mg (equivalent: erlotinib, qty 25 mg) - tablet, film coated - excipient ingredients: propylene glycol; magnesium stearate; lactose monohydrate; sodium lauryl sulfate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; hypromellose; hyprolose - non-small cell lung cancer,erlotinib arx is indicated for the first-line treatment of patients with advanced (stage iiib) or metastatic (stage iv) non-small cell lung cancer (nsclc) with activating egfr mutations.,erlotinib arx is indicated for maintenance 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 arx 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 arx in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

New Zealand - English - 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.

United States - English - 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