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Capecitabine SUN (capecitabine)

Region

🇪🇺 EU

Active substance

capecitabine

Company

Sun Pharmaceutical Industries Europe B.V.

Status

Withdrawn

Therapeutic area

Stomach Neoplasms; Breast Neoplasms; Colonic Neoplasms; Colorectal Neoplasms

EU approval

Fri 21 Jun 2013

Designations

Generic

Application

EMEA/H/C/002050

ATC

L01BC06

Official record

www.ema.europa.eu

Indication

Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine is indicated for the treatment of metastatic colorectal cancer. Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Capecitabine 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 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
• 🇪🇺 Capecitabine Accord Authorised · Accord Healthcare S.L.U.
• 🇪🇺 Xeloda Authorised · CHEPLAPHARM Arzneimittel GmbH

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.