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Fablyn

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Status: Withdrawn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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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