Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 24 April 2018

Indication(s)

Xeloda is indicated for the treatment of:
-for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.
- metastatic colorectal cancer.
- first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.
- in combination with docetaxel for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
- 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.

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Category Value
Agency product number EMEA/H/C/000316
Orphan designation No
Date First Approved 02-02-2001
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Roche Registration Ltd.