Malta - Englisch - Medicines Authority

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

Malta - Englisch - Medicines Authority

pharmascience international ltd lampousas 1, 1095 nicosia , cyprus - erlotinib hydrochloride - film-coated tablet - erlotinib hydrochloride 150 mg - antineoplastic agents

Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - 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

Neuseeland - Englisch - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg - film coated tablet - 25 mg - active: erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg 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.

Vereinigte Staaten - Englisch - 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 - Englisch - 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.

Neuseeland - Englisch - 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.

Neuseeland - Englisch - 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.

Japan - Englisch - すりの適正使用協議会 RAD-AR Council, Japan

nippon kayaku - erlotinib hydrochloride - white to yellowish white tablet (diameter: 6.5mm, thickness: 3.2mm)