Protelos

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Withdrawn

This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Protelos has been withdrawn at the request of the marketing-authorisation holder.

List item

Protelos : EPAR - Summary for the public (PDF/678.14 KB)

First published: 04/12/2009
Last updated: 16/07/2014
- Bulgarian
  (PDF/757.56 KB)
- Croatian
  (PDF/661.85 KB)
- Czech
  (PDF/712.37 KB)
- Danish
  (PDF/638.88 KB)
- Dutch
  (PDF/639.17 KB)
- Estonian
  (PDF/638.18 KB)
- Finnish
  (PDF/638.75 KB)
- French
  (PDF/642.92 KB)
- German
  (PDF/642.93 KB)
- Greek
  (PDF/759.72 KB)
- Hungarian
  (PDF/707.67 KB)
- Italian
  (PDF/638.89 KB)
- Latvian
  (PDF/713.87 KB)
- Lithuanian
  (PDF/1.24 MB)
- Maltese
  (PDF/715.31 KB)
- Polish
  (PDF/711.93 KB)
- Portuguese
  (PDF/641.93 KB)
- Romanian
  (PDF/662.83 KB)
- Slovak
  (PDF/712.98 KB)
- Slovenian
  (PDF/722.72 KB)
- Spanish
  (PDF/642.48 KB)
- Swedish
  (PDF/661.61 KB)

This EPAR was last updated on 15/05/2020

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

List item

Protelos : EPAR - Product Information (PDF/1.02 MB)

First published: 04/12/2009
Last updated: 07/12/2018
- Bulgarian
  (PDF/1.94 MB)
- Croatian
  (PDF/1.1 MB)
- Czech
  (PDF/1.52 MB)
- Danish
  (PDF/1.14 MB)
- Dutch
  (PDF/1.09 MB)
- Estonian
  (PDF/993.95 KB)
- Finnish
  (PDF/1.1 MB)
- French
  (PDF/996.08 KB)
- German
  (PDF/993.93 KB)
- Greek
  (PDF/2.06 MB)
- Hungarian
  (PDF/1.68 MB)
- Icelandic
  (PDF/983.35 KB)
- Italian
  (PDF/1010.81 KB)
- Latvian
  (PDF/1.74 MB)
- Lithuanian
  (PDF/1.04 MB)
- Maltese
  (PDF/1.85 MB)
- Norwegian
  (PDF/1.24 MB)
- Polish
  (PDF/1.69 MB)
- Portuguese
  (PDF/1.02 MB)
- Romanian
  (PDF/962.85 KB)
- Slovak
  (PDF/1.71 MB)
- Slovenian
  (PDF/1.58 MB)
- Spanish
  (PDF/1.01 MB)
- Swedish
  (PDF/1.09 MB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Protelos : EPAR - All Authorised presentations (PDF/622.53 KB)

First published: 21/11/2005
Last updated: 21/11/2005
- Bulgarian
  (PDF/632.64 KB)
- Czech
  (PDF/663.31 KB)
- Danish
  (PDF/622.62 KB)
- Dutch
  (PDF/623.43 KB)
- Estonian
  (PDF/620.99 KB)
- Finnish
  (PDF/622.47 KB)
- French
  (PDF/622.34 KB)
- German
  (PDF/626.73 KB)
- Greek
  (PDF/664.97 KB)
- Hungarian
  (PDF/639.69 KB)
- Italian
  (PDF/620.5 KB)
- Latvian
  (PDF/663.02 KB)
- Lithuanian
  (PDF/642.62 KB)
- Maltese
  (PDF/663.2 KB)
- Polish
  (PDF/653.06 KB)
- Portuguese
  (PDF/624.08 KB)
- Romanian
  (PDF/631.72 KB)
- Slovak
  (PDF/652.82 KB)
- Slovenian
  (PDF/658.42 KB)
- Spanish
  (PDF/622.47 KB)
- Swedish
  (PDF/623.35 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.

Protelos

Table of contents

Overview

Protelos : EPAR - Summary for the public (PDF/678.14 KB)

Authorisation details

Product information

Protelos : EPAR - Product Information (PDF/1.02 MB)

Protelos : EPAR - All Authorised presentations (PDF/622.53 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Protelos : EPAR - Procedural steps taken and scientific information after authorisation (PDF/745.93 KB)

Protelos-H-C-560-PSUV-0042 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/664.09 KB)

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

Protelos-H-C-560-PSU-0031 : EPAR - Assessment Report – Periodic safety update report (PDF/2.75 MB)

Protelos-H-C-560-PSU-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/694.53 KB)

Protelos and Osseor Article-20 procedure: PRAC List of questions (PDF/644.27 KB)

Protelos and Osseor Article-20 procedure: Notification (PDF/699.65 KB)

Protelos and Osseor Article-20 procedure: Review started (PDF/626.27 KB)

Protelos and Osseor Article-20 procedure: Timetable for the procedure (PDF/625.28 KB)

Protelos-H-C-560-II-0031 : EPAR - Assessment Report - Variation (PDF/2.25 MB)

CHMP post-authorisation summary of positive opinion for Protelos (PDF/606.34 KB)

Initial marketing-authorisation documents

Protelos : EPAR - Scientific Discussion (PDF/892.38 KB)

Protelos : EPAR - Procedural steps taken before authorisation (PDF/649.58 KB)

News

More information on Protelos

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)

Public statement on Protelos: Withdrawal of the marketing authorisation in the European Union (PDF/118.19 KB)

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