Fablyn (lasofoxifene)
- Region
- 🇪🇺 EU
- Active substance
- lasofoxifene
- Company
- Dr. Friedrich Eberth Arzneimittel GmbH
- Status
- Lapsed
- Therapeutic area
- Osteoporosis, Postmenopausal
- EU approval
- Tue 24 Feb 2009
- Application
- EMEA/H/C/000977
- ATC
- G03
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.