Osseor
strontium ranelate
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Osseor has been withdrawn at the request of the marketing-authorisation holder.
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 |
Product information
22/05/2018 Osseor - EMEA/H/C/000561 - SW/0045
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Drugs for treatment of bone diseases
Therapeutic indication
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
News
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23/05/2014
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21/02/2014
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 201424/01/2014
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10/01/2014
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10/01/2014
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17/05/2013
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26/04/2013
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26/04/2013
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12/04/2013
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25/05/2012
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16/03/2012
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16/03/2012
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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20/10/2011
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16/11/2007