Basic Information
Capecitabine Accord
Regulatory Information
EMEA/H/C/002386
April 20, 2012
19
May 5, 2025
Company Information
Spain
Edificio Este Planta 6a World Trade Center Moll De Barcelona S/n 08039 Barcelona
ACCORD HEALTHCARE SL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer. Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Accord 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 Accord 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.
Overview Summary
Capecitabine Accord is a cancer medicine that is used to treat: - colon (large bowel) cancer. Capecitabine Accord 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 Accord is used on its own or with other cancer medicines; - advanced gastric (stomach) cancer. Capecitabine Accord 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 Accord 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 Accord is a ‘generic’ and a ‘hybrid’ medicine. This means that it is similar to a ‘reference medicine’, but it contains capecitabine at a new strength in addition to existing strengths. While the reference medicine, Xeloda, is available as 150 and 500 mg tablets, Capecitabine Accord is also available as 300 mg tablets. Capecitabine Accord contains the active substance capecitabine.