Protelos

RSS

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 07/12/2018

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
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 Protelos - EMEA/H/C/000560 - SW/0050

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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