colesevelam - EPARs for authorised medicinal products for human use - Cholestagel

FICHA FARMACOLÓGICA de colesevelam . 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. MAYO 03, 2010.-

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EPARs for authorised medicinal products for human use - Cholestagel

Active Substance
colesevelam
International Nonproprietary Name or Common Name
colesevelam
Pharmaco-therapeutic Group
Bile acid sequestrants
ATC Code
C10AC04

Therapeutic Indication:
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.

Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.

Date of issue of Marketing Authorisation valid throughout the European Union
10 March 2004


Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use