Belgija - angleščina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - erlotinib hydrochloride 163,9 mg - eq. erlotinib 150 mg - film-coated tablet - 150 mg - erlotinib hydrochloride 163.9 mg - erlotinib

Belgija - angleščina - 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

Belgija - angleščina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - erlotinib hydrochloride 109,27 mg - eq. erlotinib 100 mg - film-coated tablet - 100 mg - erlotinib hydrochloride 109.27 mg - erlotinib

Belgija - angleščina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz sa-nv - erlotinib hydrochloride 163,9 mg - eq. erlotinib 150 mg - film-coated tablet - 150 mg - erlotinib hydrochloride 163.9 mg - erlotinib

Združene države Amerike - angleščina - 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

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - erlotinib hydrochloride, quantity: 109.27 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - non-small cell lung cancer erlotinib sandoz 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 sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfrmutations who have not progressed on first-line chemotherapy.,erlotinib sandoz 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 sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - erlotinib hydrochloride, quantity: 27.32 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; sodium starch glycollate type a; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - non-small cell lung cancer erlotinib sandoz 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 sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfrmutations who have not progressed on first-line chemotherapy.,erlotinib sandoz 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 sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - erlotinib hydrochloride, quantity: 163.9 mg - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type a; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; sodium bicarbonate; methacrylic acid copolymer - non-small cell lung cancer erlotinib sandoz 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 sandoz is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with activating egfrmutations who have not progressed on first-line chemotherapy.,erlotinib sandoz 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 sandoz in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

breckenridge pharmaceutical, 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 mechanis

Združene države Amerike - angleščina - NLM (National Library of Medicine)

armas pharmaceuticals inc. - 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 based on animal data and its mechanism of action, erlotinib tablets