Fablyn

Lapsed

This medicine's authorisation has lapsed

lasofoxifene

Overview

On 24 February 2009, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Fablyn (lasofoxifene), indicated for the treatment of osteoporosis in postmenopausal women. The marketing authorisation holder was notified on the 26 February 2009. Fablyn (lasofoxifene) had not been marketed in Europe since this initial marketing authorisation. 

In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation. Because of this, from 27 February 2012, the marketing authorisation for Fablyn is no longer valid. 

Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Fablyn is updated to reflect that the marketing authorisation is no longer valid.

Fablyn : EPAR - Summary for the public

Product information

Fablyn : EPAR - Product Information

Fablyn : EPAR - All Authorised presentations

Fablyn : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

Product details

• Name of medicine:
  Fablyn
• Active substance:
  Lasofoxifene tartrate
• International non-proprietary name (INN) or common name:
  lasofoxifene
• Therapeutic area (MeSH):
  Osteoporosis, Postmenopausal
• Anatomical therapeutic chemical (ATC) code:
  G03

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).

Authorisation details

• EMA product number:
  EMEA/H/C/000977
• Marketing authorisation holder:
  Dr. Friedrich Eberth Arzneimittel GmbH

  Am Bahnhof 2; D-92289 Ursensollen; Germany

• Marketing authorisation issued:
  24/02/2009
• Lapse of marketing authorisation:
  27/02/2012
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Fablyn : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Fablyn : EPAR - Public assessment report

Committee for medicinal products for human use summary of positive opinion for Fablyn

Reference Number: EMEA/CHMP/609979/2008