Xeloda

RSS

capecitabine

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 20/04/2018

Authorisation details

Product details
Name
Xeloda
Agency product number
EMEA/H/C/000316
Active substance
capecitabine
International non-proprietary name (INN) or common name
capecitabine
Therapeutic area (MeSH)
  • Colonic Neoplasms
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Stomach Neoplasms
Anatomical therapeutic chemical (ATC) code
L01BC06
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
02/02/2001
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

22/03/2018 Xeloda - EMEA/H/C/000316 - II/0074

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

  • 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.

Assessment history

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