Protelos

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strontium ranelate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Protelos. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protelos.

This EPAR was last updated on 11/10/2016

Authorisation details

Product details
Name
Protelos
Agency product number
EMEA/H/C/000560
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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
21/09/2004
Contact address
Les laboratoires Servier
50, rue Carnot
F-92284 Suresnes Cedex
France

Product information

15/09/2016 Protelos - EMEA/H/C/000560 - II/0047

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

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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