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Active Substance: lasofoxifene tartrate
Common Name: lasofoxifene
ATC Code: G03
Marketing Authorisation Holder: Dr. Friedrich Eberth Arzneimittel GmbH
Active Substance: lasofoxifene tartrate
Status: Withdrawn
Authorisation Date: 2009-02-24
Therapeutic Area: Osteoporosis, Postmenopausal
Pharmacotherapeutic Group: Sex hormones and modulators of the genital system

Therapeutic Indication

Fablyn is indicated for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. A significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures has been demonstrated (see section 5.1).

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

The marketing authorisation for Fablyn has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

Source: European Medicines Agency

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