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🇪🇺EU · EMAAuthorisedATC: L01BC06

Capecitabine Medac(capecitabine)

Colorectal Neoplasms

Marketing Authorisation Holder: medac Gesellschaft für klinische Spezialpräparate mbH

EMA Authorisation: 19/11/2012

INN: capecitabine

Indication

Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer. Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine Medac 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 Medac 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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.