Fablyn
Lapsed
This medicine's authorisation has lapsed
lasofoxifene
MedicineHumanLapsed
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- Application under evaluation
- CHMP opinion
- European Commission decision
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 Because of this, from 27 February 2012, the marketing authorisation for Fablyn is no longer valid.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the European Assessment Report (EPAR) for Fablyn is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:T/0003
27/02/2012
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 systemTherapeutic 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).
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