Osseor

Withdrawn

This medicine's authorisation has been withdrawn

strontium ranelate

Overview

The marketing authorisation for Osseor has been withdrawn at the request of the marketing-authorisation holder.

Osseor : EPAR - Summary for the public

Product information

Osseor : EPAR - Product Information

Latest procedure affecting product information: SW/0045

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).

Osseor : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Osseor
• 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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000561
• 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

Changes since initial authorisation of medicine

Osseor : EPAR - Procedural steps taken and scientific information after authorisation

Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report

Reference Number: EMA/112925/2014

Osseor-H-C-561-PSUV-0037 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/222395/2014

Osseor-H-C-561-PSU-0031 : EPAR - Assessment Report - Periodic safety update report

AdoptedReference Number: EMA/PRAC/136656/2013

Osseor-H-C-561-PSU-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

AdoptedReference Number: EMA/CHMP/257649/2013

Osseor-H-C-561-II-0027 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/353622/2012

Osseor-H-C-561-A20-0030 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/CHMP/261595/2012

CHMP post-authorisation summary of positive opinion for Osseor

AdoptedReference Number: EMA/311245/2012

Initial marketing authorisation documents

Osseor : EPAR - Scientific Discussion

Osseor : EPAR - Procedural steps taken before authorisation