Capecitabine - EPARs for authorised medicinal products for human use - Xeloda

FICHA FARMACOLÓGICA de Capecitabine. Contiene la Monografía en distintos idiomas (de la Unión Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Se recuerda que todas las informaciones científico-clínicas, así como técnicas propias de la producción, sólo se publican en idioma inglés. Cerasale. ABRIL 21, 2010.-

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EPARs for authorised medicinal products for human use - Xeloda

Active Substance
Capecitabine
International Nonproprietary Name or Common Name
Capecitabine
Pharmaco-therapeutic Group
Cytostatic (antimetabolite)
ATC Code
L01BC06


Therapeutic 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.


Date of issue of Marketing Authorisation valid throughout the European Union
2 February 2001

Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use