United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - capecitabine 150 mg - capecitabine tablets are indicated for the: - adjuvant treatment of patients with stage iii colon cancer as a single agent or as a component of a combination chemotherapy regimen. - perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. - treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. capecitabine tablets are indicated for the: - treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated. - treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. capecitabine tablets are indicated for the: - treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. - trea

United States - English - NLM (National Library of Medicine)

armas pharmaceuticals inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - - capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with dukes' c colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. capecitabine tablets are non-inferior to 5-fluorouracil and leucovorin (5-fu/lv) for disease-free survival (dfs). physicians should consider results of combination chemotherapy trials, which have shown improvement in dfs and os, when prescribing single-agent capecitabine tablets in the adjuvant treatment of dukes' c colon cancer. - capecitabine tablets are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. combination chemotherapy has shown a survival benefit compared to 5-fu/lv alone. a survival benefit over 5-fu/lv has not been demonstrated with capecitabine tablets monotherapy. use of capecitabine tablets instead of 5-fu/lv in combinations has not been adequately studied to

United States - English - NLM (National Library of Medicine)

armas pharmaceuticals inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - - capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with dukes' c colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. capecitabine tablets are non-inferior to 5-fluorouracil and leucovorin (5-fu/lv) for disease-free survival (dfs). physicians should consider results of combination chemotherapy trials, which have shown improvement in dfs and os, when prescribing single-agent capecitabine tablets in the adjuvant treatment of dukes' c colon cancer. - capecitabine tablets are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. combination chemotherapy has shown a survival benefit compared to 5-fu/lv alone. a survival benefit over 5-fu/lv has not been demonstrated with capecitabine tablets monotherapy. use of capecitabine tablets instead of 5-fu/lv in combinations has not been adequately studied to

United States - English - NLM (National Library of Medicine)

celltrion usa, inc. - capecitabine (unii: 6804dj8z9u) (capecitabine - unii:6804dj8z9u) - - capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with dukes' c colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. capecitabine tablets are non-inferior to 5-fluorouracil and leucovorin (5-fu/lv) for disease-free survival (dfs). physicians should consider results of combination chemotherapy trials, which have shown improvement in dfs and os, when prescribing single-agent capecitabine tablets in the adjuvant treatment of dukes' c colon cancer. - capecitabine tablets are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. combination chemotherapy has shown a survival benefit compared to 5-fu/lv alone. a survival benefit over 5-fu/lv has not been demonstrated with capecitabine tablets monotherapy. use of capecitabine tablets instead of 5-fu/lv in combinations has not been adequately studied to

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

accord healthcare pty ltd - capecitabine -

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

accord healthcare pty ltd - capecitabine -

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

arrotex pharmaceuticals pty ltd - capecitabine, quantity: 150 mg - tablet, film coated - excipient ingredients: titanium dioxide; iron oxide red; macrogol 8000; magnesium stearate; lactose; colloidal anhydrous silica; methylcellulose; hypromellose; iron oxide yellow; hyprolose; croscarmellose sodium - colon cancer,capecitabine is indicated for the adjuvant treatment of patients with dukes' stage c and high-risk stage b, colon cancer, either as monotherapy or in combination with oxaliplatin.,colorectal cancer,capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,oesophagogastric cancer,capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,breast cancer,capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

Israel - English - Ministry of Health

abic marketing ltd, israel - capecitabine - film coated tablets - capecitabine 150 mg - capecitabine - adjuvant colon cancer: capecitabine teva® is indicated for the adjuvant treatment of patients following surgery of stage iii (dukesע stage c) colon cancer. colorectal cancer: capecitabine teva® is indicated for the treatment of patients with advanced or metastatic colorectal cancer. advanced gastric cancer: capecitabine teva® is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy. breast cancer combination therapy: capecitabine teva® in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. breast cancer monotherapy: capecitabine teva® is also indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

Israel - English - Ministry of Health

abic marketing ltd, israel - capecitabine - film coated tablets - capecitabine 500 mg - capecitabine - adjuvant colon cancer: capecitabine teva® is indicated for the adjuvant treatment of patients following surgery of stage iii (dukes stage c) colon cancer. colorectal cancer: capecitabine teva® is indicated for the treatment of patients with advanced or metastatic colorectal cancer. advanced gastric cancer: capecitabine teva® is indicated for first line treatment of advanced gastric cancer in combination with chemotherapy. breast cancer combination therapy: capecitabine teva® in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. breast cancer monotherapy: capecitabine teva® is also indicated for the treatment of advanced or metastatic breast cancer after failure of standard therapy including a taxane unless therapy with a taxane is clinically contraindicated.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - capecitabine - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastic agents - capecitabine accord is indicated for the adjuvant treatment of patients following surgery of stage-iii (dukes’ stage-c) colon cancer.capecitabine accord is indicated for the treatment of metastatic colorectal cancer.capecitabine accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.capecitabine accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. previous therapy should have included an anthracycline.capecitabine accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.