Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 20 June 2017

Indication(s)

Capecitabine medac is indicated:
• for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.
• for the treatment of metastatic colorectal cancer.
• for first-line treatment of advanced gastric cancer in combination with a platinum based regimen.
• in combination with docetaxel 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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Category Value
Agency product number EMEA/H/C/002568
Orphan designation No
Date First Approved 19-11-2012
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder medac Gesellschaft für klinische Spezialpräparate mbH