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

eg sa-nv - erlotinib hydrochloride 27,32 mg - eq. erlotinib 25 mg - film-coated tablet - 25 mg - erlotinib hydrochloride 27.32 mg - erlotinib

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

sandoz sa-nv - erlotinib hydrochloride 27,32 mg - eq. erlotinib 25 mg - film-coated tablet - 25 mg - erlotinib hydrochloride 27.32 mg - erlotinib

Malta - English - Medicines Authority

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

Israel - English - 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.

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.

Israel - English - 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 - English - 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.

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