Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - 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 tablets are not recommended for use in combination with platinum-based chemotherapy [see clinical studies (14.4)] . erlotinib tablets in combination with gemcitabine are 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 mec

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - 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 tablets are not recommended for use in combination with platinum-based chemotherapy [see clinical studies (14.4)] . erlotinib tablets in combination with gemcitabine are 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 i

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

areva pharmaceuticals - erlotinib hydrochloride (unii: da87705x9k) (erlotinib - unii:j4t82ndh7e) - erlotinib tablets was 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 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 mechan

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - erlotinib hydrochloride - oral tablet - 25mg

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

a a h pharmaceuticals ltd - erlotinib hydrochloride - oral tablet - 25mg

Neuseeland - Englisch - Medsafe (Medicines Safety Authority)

alchemy health limited - erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg - film coated tablet - 50 mg - active: erlotinib hydrochloride 54.63mg equivalent to erlotinib 50mg 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.

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

amarox ltd - erlotinib hydrochloride - oral tablet - 25mg

Vereinigtes Königreich - Englisch - MHRA (Medicines & Healthcare Products Regulatory Agency)

glenmark pharmaceuticals europe ltd - erlotinib hydrochloride - oral tablet - 25mg

Singapur - Englisch - HSA (Health Sciences Authority)

intega pte ltd - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 100.00mg

Singapur - Englisch - HSA (Health Sciences Authority)

intega pte ltd - erlotinib hydrochloride eqv erlotinib - tablet, film coated - erlotinib hydrochloride eqv erlotinib 150.00mg