Xeloda (capecitabine)
- Region
- 🇪🇺 EU
- Active substance
- capecitabine
- Company
- CHEPLAPHARM Arzneimittel GmbH
- Status
- Authorised
- Therapeutic area
- Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
- CHMP opinion
- Thu 19 Oct 2000
- EU approval
- Fri 02 Feb 2001
- Application
- EMEA/H/C/000316
- ATC
- L01BC06
- Official record
- www.ema.europa.eu
Indication
Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for the treatment of metastatic colorectal cancer. Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Xeloda 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. Xeloda 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.
- 🇪🇺 Capecitabine SUN Withdrawn · Sun Pharmaceutical Industries Europe B.V.
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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.