Capecitabine Medac (capecitabine)
- Region
- 🇪🇺 EU
- Active substance
- capecitabine
- Company
- medac Gesellschaft für klinische Spezialpräparate mbH
- Status
- Authorised
- Therapeutic area
- Colorectal Neoplasms
- EU approval
- Mon 19 Nov 2012
- Designations
- Generic
- Application
- EMEA/H/C/002568
- ATC
- L01BC06
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Capecitabine Teva Authorised · Teva Pharma B.V.
- 🇪🇺 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
- 🇪🇺 Capecitabine SUN Withdrawn · Sun Pharmaceutical Industries Europe B.V.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.