United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - erlotinib hydrochloride - tablet - 150mg

Singapore - English - HSA (Health Sciences Authority)

lotus international pte. ltd. - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 150.00mg

United States - English - 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

United States - English - 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

Israel - English - Ministry of Health

teva israel ltd - erlotinib as hydrochloride - film coated tablets - erlotinib as hydrochloride 150 mg - erlotinib - non-small cell lung cancer (nsclc): erlotinib teva 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 teva 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 teva 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 teva is indicated in combination with gemcitabine for the first-line 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.

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

nippon kayaku - erlotinib hydrochloride - white to yellowish white tablet (diameter: 9.6mm, thickness: 5.0mm)

United States - English - 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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

intega sdn. bhd. - erlotinib hydrochloride -

Canada - English - Health Canada

natco pharma (canada) inc - erlotinib (erlotinib hydrochloride) - tablet - 25mg - erlotinib (erlotinib hydrochloride) 25mg - antineoplastic agents