Osseor

strontium ranelate

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Osseor has been withdrawn at the request of the marketing-authorisation holder.

List item

Osseor : EPAR - Summary for the public (PDF/639.48 KB)

First published: 04/12/2009
Last updated: 16/07/2014
- Bulgarian
  (PDF/756.91 KB)
- Croatian
  (PDF/660.67 KB)
- Czech
  (PDF/712.71 KB)
- Danish
  (PDF/638.69 KB)
- Dutch
  (PDF/639.2 KB)
- Estonian
  (PDF/638.5 KB)
- Finnish
  (PDF/639.21 KB)
- French
  (PDF/642.44 KB)
- German
  (PDF/642.97 KB)
- Greek
  (PDF/759.01 KB)
- Hungarian
  (PDF/708.21 KB)
- Italian
  (PDF/638.87 KB)
- Latvian
  (PDF/1.32 MB)
- Lithuanian
  (PDF/697.68 KB)
- Maltese
  (PDF/715.36 KB)
- Polish
  (PDF/734.75 KB)
- Portuguese
  (PDF/664.08 KB)
- Romanian
  (PDF/663.01 KB)
- Slovak
  (PDF/713.56 KB)
- Slovenian
  (PDF/727.28 KB)
- Spanish
  (PDF/664.71 KB)
- Swedish
  (PDF/639.5 KB)

More detail is available in the summary of product characteristics

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

List item

Osseor : EPAR - Product Information (PDF/1.04 MB)

First published: 04/12/2009
Last updated: 07/12/2018
- Bulgarian
  (PDF/1.91 MB)
- Croatian
  (PDF/1.1 MB)
- Czech
  (PDF/1.6 MB)
- Danish
  (PDF/1.11 MB)
- Dutch
  (PDF/1.12 MB)
- Estonian
  (PDF/968.4 KB)
- Finnish
  (PDF/1.1 MB)
- French
  (PDF/1.07 MB)
- German
  (PDF/1.06 MB)
- Greek
  (PDF/2.11 MB)
- Hungarian
  (PDF/1.69 MB)
- Icelandic
  (PDF/1.06 MB)
- Italian
  (PDF/1.06 MB)
- Latvian
  (PDF/1.78 MB)
- Lithuanian
  (PDF/1.05 MB)
- Maltese
  (PDF/1.79 MB)
- Norwegian
  (PDF/1.12 MB)
- Polish
  (PDF/1.71 MB)
- Portuguese
  (PDF/990.79 KB)
- Romanian
  (PDF/1.04 MB)
- Slovak
  (PDF/1.73 MB)
- Slovenian
  (PDF/1.59 MB)
- Spanish
  (PDF/1.03 MB)
- Swedish
  (PDF/1.1 MB)

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.

List item

Osseor : EPAR - All Authorised presentations (PDF/622.5 KB)

First published: 21/11/2005
Last updated: 21/11/2005
- Bulgarian
  (PDF/631.65 KB)
- Czech
  (PDF/663.13 KB)
- Danish
  (PDF/622.56 KB)
- Dutch
  (PDF/623.5 KB)
- Estonian
  (PDF/621.3 KB)
- Finnish
  (PDF/622.44 KB)
- French
  (PDF/622.66 KB)
- German
  (PDF/627.49 KB)
- Greek
  (PDF/663.76 KB)
- Hungarian
  (PDF/639.67 KB)
- Italian
  (PDF/620.8 KB)
- Latvian
  (PDF/663.05 KB)
- Lithuanian
  (PDF/642.87 KB)
- Maltese
  (PDF/662.9 KB)
- Polish
  (PDF/653.25 KB)
- Portuguese
  (PDF/624.39 KB)
- Romanian
  (PDF/631.72 KB)
- Slovak
  (PDF/653 KB)
- Slovenian
  (PDF/658.67 KB)
- Spanish
  (PDF/622.11 KB)
- Swedish
  (PDF/623.74 KB)

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.

Osseor

Table of contents

Overview

Osseor : EPAR - Summary for the public (PDF/639.48 KB)

Authorisation details

Product information

Osseor : EPAR - Product Information (PDF/1.04 MB)

Contents

Osseor : EPAR - All Authorised presentations (PDF/622.5 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Osseor : EPAR - Procedural steps taken and scientific information after authorisation (PDF/743.34 KB)

Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report (PDF/1.49 MB)

Osseor-H-C-561-PSUV-0037 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/626.2 KB)

Osseor-H-C-561-PSU-0031 : EPAR - Assessment Report - Periodic safety update report (PDF/2.75 MB)

Osseor-H-C-561-PSU-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/694.44 KB)

Osseor-H-C-561-II-0027 : EPAR - Assessment Report - Variation (PDF/2.19 MB)

Osseor-H-C-561-A20-0030 : EPAR - Assessment Report - Article 20 (PDF/683.97 KB)

CHMP post-authorisation summary of positive opinion for Osseor (PDF/606.31 KB)

Initial marketing-authorisation documents

Osseor : EPAR - Scientific Discussion (PDF/899.88 KB)

Osseor : EPAR - Procedural steps taken before authorisation (PDF/649.44 KB)

News

More information on Osseor

Public statement on Osseor: Withdrawal of the marketing authorisation in the European Union (PDF/118.05 KB)

Protelos and Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report (PDF/950 KB)

PRAC recommends restriction in the use of Protelos / Osseor: Questions and answers (PDF/73.99 KB)

Questions and answers on the review of Protelos and Osseor (strontium ranelate) (PDF/67.99 KB)

Protelos / Osseor: Product information as approved by the CHMP on 15 March 2012, pending endorsement by the European Commission (PDF/399.86 KB)

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