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.
Fablyn : EPAR - Summary for the public (PDF/340.06 KB)
First published: 23/03/2009
Last updated: 22/06/2012
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Dr. Friedrich Eberth Arzneimittel GmbH
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27/02/2012 Fablyn - EMEA/H/C/000977 - T/0003
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Sex hormones and modulators of the genital system
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).