Xeloda

RSS

capecitabine

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

Overview

Xeloda is a cancer medicine that is used to treat:

  • colon (large bowel) cancer. Xeloda is used on its own or with other cancer medicines in patients who have had surgery for stage III or Dukes’ stage C colon cancer;
  • metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body). Xeloda is used on its own or with other cancer medicines;
  • advanced gastric (stomach) cancer. Xeloda is used with other cancer medicines, including a platinum-containing cancer medicine such as cisplatin;
  • locally advanced or metastatic breast cancer (breast cancer that has begun to spread to other parts of the body). Xeloda is used with docetaxel (another cancer medicine) after treatment with anthracyclines (another type of cancer medicine) has failed. It can also be used on its own when treatment with both anthracyclines and taxanes (another type of cancer medicine) has failed or when further treatment with anthracyclines is not suitable for the patient.

Xeloda contains the active substance capecitabine.

This EPAR was last updated on 07/09/2021

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
28
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

09/08/2021 Xeloda - EMEA/H/C/000316 - N/0094

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

Changes since initial authorisation of medicine

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