Capecitabine Teva

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capecitabine

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

Overview

Capecitabine Teva is a cancer medicine that is used to treat:

 

  • colon (large bowel) cancer. Capecitabine Teva 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). Capecitabine Teva is used on its own or with other cancer medicines;
  • advanced gastric (stomach) cancer. Capecitabine Teva 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). Capecitabine Teva 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.

Capecitabine Teva is a ‘generic medicine’. This means that Capecitabine Teva contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Xeloda.

Capecitabine Teva contains the active substance capecitabine.

This EPAR was last updated on 29/07/2020

Authorisation details

Product details
Name
Capecitabine Teva
Agency product number
EMEA/H/C/002362
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
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
20/04/2012
Contact address
Computerweg 10
NL-3542 DR Utrecht
The Netherlands

Product information

03/07/2020 Capecitabine Teva - EMEA/H/C/002362 - IB/0034

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.

Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.

Capecitabine Teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.

Capecitabine Teva 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 Teva 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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