Protelos
strontium ranelate
Table of contents
Overview
The marketing authorisation for Protelos has been withdrawn at the request of the marketing-authorisation holder.
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 |
Product information
22/05/2018 Protelos - EMEA/H/C/000560 - SW/0050
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.
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
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