Fablyn

RSS

lasofoxifene

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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.

This EPAR was last updated on 21/06/2012

Authorisation details

Product details
Name
Fablyn
Agency product number
EMEA/H/C/000977
Active substance
Lasofoxifene tartrate
International non-proprietary name (INN) or common name
lasofoxifene
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
G03
Publication details
Marketing-authorisation holder
Dr. Friedrich Eberth Arzneimittel GmbH
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
24/02/2009
Contact address
Am Bahnhof 2
D-92289 Ursensollen
Germany

Product information

27/02/2012 Fablyn - EMEA/H/C/000977 - T/0003

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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).

Assessment history

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