4.1 Therapeutic indications
Capecitabine Mylan is indicated for the treatment of:
• adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1).
• metastatic colorectal cancer (see section 5.1).
• first-line treatment of advanced gastric cancer in combination with a platinum-based regimen (see section 5.1).
• in combination with docetaxel (see section 5.1) for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.
• 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.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).