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Capecitabine Accord (capecitabine)

Region

🇪🇺 EU

Active substance

capecitabine

Company

Accord Healthcare S.L.U.

Status

Authorised

Therapeutic area

Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

EU approval

Fri 20 Apr 2012

Designations

Generic

Application

EMEA/H/C/002386

ATC

L01BC06

Official record

www.ema.europa.eu

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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Capecitabine Teva Authorised · Teva Pharma B.V.
• 🇪🇺 Capecitabine Medac Authorised · medac Gesellschaft für klinische Spezialpräparate mbH
• 🇪🇺 Ecansya (previously Capecitabine Krka) Authorised · KRKA tovarna zdravil d.d. Novo mesto
• 🇪🇺 Xeloda Authorised · CHEPLAPHARM Arzneimittel GmbH
• 🇪🇺 Capecitabine SUN Withdrawn · Sun Pharmaceutical Industries Europe B.V.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.