This is a summary of the European public assessment report (EPAR) for Xeloda. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xeloda.
Xeloda : EPAR - Summary for the public (PDF/85.75 KB)
First published: 04/12/2008
Last updated: 19/11/2015
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Roche Registration GmbH
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22/03/2018 Xeloda - EMEA/H/C/000316 - II/0074
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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- Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer.
- Xeloda is indicated for the treatment of metastatic colorectal cancer.
- Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.
- Xeloda 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. Xeloda 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.