Malta - Inggris - Medicines Authority

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

Malta - Inggris - Medicines Authority

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

Malta - Inggris - Medicines Authority

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

Israel - Inggris - 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.

Israel - Inggris - 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.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

novadoz pharmaceuticals llc - 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 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. risk summary based on animal data and its mechanism of

Amerika Serikat - Inggris - NLM (National Library of Medicine)

msn laboratories private limited - 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 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. risk summary based on animal data and its mechanism of

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

cipla australia pty ltd - erlotinib hydrochloride, quantity: 109.267 mg (equivalent: erlotinib, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance 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 cipla 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 cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

cipla australia pty ltd - erlotinib hydrochloride, quantity: 163.9 mg (equivalent: erlotinib, qty 150 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance 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 cipla 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 cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

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

cipla australia pty ltd - erlotinib hydrochloride, quantity: 27.317 mg (equivalent: erlotinib, qty 25 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type a; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; hyprolose; macrogol 400 - non-small cell lung cancer erlotinib cipla is indicated for the first-line treatment of patients with advanced (stage iiib) or metasttic (stega iv) non-small cell lung cancer (nsclc) with activating egfr mutations. erlotinib cipla is indicated for matintenance 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 cipla 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 cipla in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.