Protelos
Withdrawn
This medicine's authorisation has been withdrawn
strontium ranelate
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Protelos has been withdrawn at the request of the marketing-authorisation holder.
Protelos : EPAR - Summary for the public
English (EN) (678.14 KB - PDF)
First published: Last updated:
български (BG) (757.56 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
español (ES) (642.48 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
čeština (CS) (712.37 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
dansk (DA) (638.88 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
Deutsch (DE) (642.93 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
eesti keel (ET) (638.18 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
ελληνικά (EL) (759.72 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
français (FR) (642.92 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
hrvatski (HR) (661.85 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
italiano (IT) (638.89 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
latviešu valoda (LV) (713.87 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
lietuvių kalba (LT) (1.24 MB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
magyar (HU) (707.67 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
Malti (MT) (715.31 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
Nederlands (NL) (639.17 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
polski (PL) (711.93 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
português (PT) (641.93 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
română (RO) (662.83 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
slovenčina (SK) (712.98 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
slovenščina (SL) (722.72 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
Suomi (FI) (638.75 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
svenska (SV) (661.61 KB - PDF)
First published: 04/12/2009Last updated: 16/07/2014
Product information
Protelos : EPAR - Product Information
English (EN) (1.02 MB - PDF)
First published: Last updated:
български (BG) (1.94 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
español (ES) (1.01 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
čeština (CS) (1.52 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
dansk (DA) (1.14 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
Deutsch (DE) (993.93 KB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
eesti keel (ET) (993.95 KB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
ελληνικά (EL) (2.06 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
français (FR) (996.08 KB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
hrvatski (HR) (1.1 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
íslenska (IS) (983.35 KB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
italiano (IT) (1010.81 KB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
latviešu valoda (LV) (1.74 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
lietuvių kalba (LT) (1.04 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
magyar (HU) (1.68 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
Malti (MT) (1.85 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
Nederlands (NL) (1.09 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
norsk (NO) (1.24 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
polski (PL) (1.69 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
português (PT) (1.02 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
română (RO) (962.85 KB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
slovenčina (SK) (1.71 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
slovenščina (SL) (1.58 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
Suomi (FI) (1.1 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
svenska (SV) (1.09 MB - PDF)
First published: 04/12/2009Last updated: 07/12/2018
Latest procedure affecting product information:
SW/0050
22/05/2018
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).
Protelos : EPAR - All Authorised presentations
English (EN) (622.53 KB - PDF)
First published: Last updated:
български (BG) (632.64 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
español (ES) (622.47 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
čeština (CS) (663.31 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
dansk (DA) (622.62 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
Deutsch (DE) (626.73 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
eesti keel (ET) (620.99 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
ελληνικά (EL) (664.97 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
français (FR) (622.34 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
italiano (IT) (620.5 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
latviešu valoda (LV) (663.02 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
lietuvių kalba (LT) (642.62 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
magyar (HU) (639.69 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
Malti (MT) (663.2 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
Nederlands (NL) (623.43 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
polski (PL) (653.06 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
português (PT) (624.08 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
română (RO) (631.72 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
slovenčina (SK) (652.82 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
slovenščina (SL) (658.42 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
Suomi (FI) (622.47 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
svenska (SV) (623.35 KB - PDF)
First published: 21/11/2005Last updated: 21/11/2005
Product details
- Name of medicine
- Protelos
- 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
Pharmacotherapeutic group
Drugs for treatment of bone diseasesTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/000560
- Marketing authorisation holder
- Les Laboratoires Servier
Les Laboratoires Servier
50 rue Carnot
F-92284 Suresnes Cedex
France - Marketing authorisation issued
- 20/09/2004
- Revision
- 19
Assessment history
Protelos and Osseor Article-20 procedure: PRAC List of questions
Reference Number: EMA/PRAC/283429/2013
English (EN) (644.27 KB - PDF)
First published: Last updated:
Protelos and Osseor Article-20 procedure: Notification
English (EN) (699.65 KB - PDF)
First published: Last updated:
Protelos and Osseor Article-20 procedure: Review started
Reference Number: EMA/291972/2013
English (EN) (626.27 KB - PDF)
First published: Last updated:
Protelos and Osseor Article-20 procedure: Timetable for the procedure
Reference Number: EMA/PRAC/283428/2013 Rev.1
English (EN) (625.28 KB - PDF)
First published: Last updated:
Protelos : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (745.93 KB - PDF)
First published: Last updated:
Protelos-H-C-560-PSUV-0042 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/222395/2014
English (EN) (664.09 KB - PDF)
First published: Last updated:
Protelos Article-20 procedure: CHMP scientific conclusions and PRAC assessment report
Reference Number: EMA/112925/2014
English (EN) (1.49 MB - PDF)
First published: Last updated:
Protelos-H-C-560-PSU-0031 : EPAR - Assessment Report – Periodic safety update report
AdoptedReference Number: EMA/PRAC/136656/2013
English (EN) (2.75 MB - PDF)
First published: Last updated:
Protelos-H-C-560-PSU-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
AdoptedReference Number: EMA/CHMP/257649/2013
English (EN) (694.53 KB - PDF)
First published: Last updated:
Protelos-H-C-560-II-0031 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/CHMP/313009/2012
English (EN) (2.25 MB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Protelos
AdoptedReference Number: EMA/313022/2012
English (EN) (606.34 KB - PDF)
First published: Last updated:
News on Protelos
More information on Protelos
Protelos and Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report
AdoptedReference Number: EMA/112925/2014
English (EN) (950 KB - PDF)
First published: Last updated:
PRAC recommends restriction in the use of Protelos / Osseor: Questions and answers
Reference Number: EMA/220628/2013
English (EN) (73.99 KB - PDF)
First published: Last updated:
Questions and answers on the review of Protelos and Osseor (strontium ranelate)
Reference Number: EMA/183047/2012
English (EN) (67.99 KB - PDF)
First published: Last updated:
Protelos / Osseor: Product information as approved by the CHMP on 15 March 2012, pending endorsement by the European Commission
English (EN) (399.86 KB - PDF)
First published: Last updated:
Public statement on Protelos: Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/234092/2020
English (EN) (118.19 KB - PDF)
First published:
More information on Protelos
This page was last updated on