nicotinic acid / laropiprant - EPARs for human use

FICHA FARMACOLÓGICA de nicotinic acid / laropiprant. 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. FEBRERO 24, 2010.-

abrir aquí para acceder al documento EMEA completo:
http://www.ema.europa.eu/humandocs/Humans/EPAR/trevaclyn/trevaclyn.htm

Active Substance
nicotinic acid / laropiprant
International Nonproprietary Name or Common Name
nicotinic acid / laropiprant
Pharmaco-therapeutic Group
Nicotinic acid and derivatives
ATC Code
C10AD52

Therapeutic Indication:
Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL cholesterol and triglycerides and low HDL cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non familial).


Trevaclyn should be used in patients in combination with HMG CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG CoA reductase inhibitors are considered inappropriate or not tolerated. Diet and other non pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Trevaclyn.

Date of issue of Marketing Authorisation valid throughout the European Union
3 July 2008


Orphan medicinal product designation date
Not applicable


EPARs for authorised medicinal products for human use