EPARs - Evista/raloxifene hydrocloride

FICHA FARMACOLÓGICA de raloxifene hydrocloride. Contiene la Monografía en distintos idiomas (de la Comunidad Económica 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. Cerasale. ABRIL 01, 2009.

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EPARs for authorised medicinal products for human use - Evista

Active Substance
raloxifene hydrocloride
International Nonproprietary Name or Common Name
raloxifene hydrocloride
Pharmaco-therapeutic Group
Selective Estrogen Receptor Modulator (SERM)
ATC Code
G03X C01

Therapeutic Indication:
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.

When determining the choice of EVISTA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).

Date of issue of Marketing Authorisation valid throughout the European Union
5 August 1998