Osseor

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strontium ranelate

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Osseor has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 19/05/2020

Authorisation details

Product details
Name
Osseor
Agency product number
EMEA/H/C/000561
Active substance
strontium ranelate
International non-proprietary name (INN) or common name
strontium ranelate
Therapeutic area (MeSH)
Osteoporosis, Postmenopausal
Anatomical therapeutic chemical (ATC) code
M05BX03
Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
20/09/2004
Contact address

Les laboratoires Servier
50, rue Carnot
F-92284 Suresnes Cedex
France

Product information

22/05/2018 Osseor - EMEA/H/C/000561 - SW/0045

Contents

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Pharmacotherapeutic group

Drugs for treatment of bone diseases

Therapeutic indication

Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures.

Treatment of severe osteoporosis in adult men at increased risk of fracture.

The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks.

Assessment history

Changes since initial authorisation of medicine

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