Protelos

Withdrawn

This medicine's authorisation has been withdrawn

strontium ranelate

Overview

On 14 April 2020, the European Commission withdrew the marketing authorisation for Protelos (strontium ranelate) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Les Laboratoires Servier, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Protelos was granted marketing authorisation in the EU on 21 September 2004 for treatment of osteoporosis. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2009. It was then granted unlimited validity in 2014. The product had not been marketed in the EU since 2017. 

The European Public Assessment Report (EPAR) for Protelos is updated to indicate that the marketing authorisation is no longer valid.

Protelos : EPAR - Summary for the public

Product information

Protelos : EPAR - Product Information

Protelos : EPAR - All Authorised presentations

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 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/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

Changes since initial authorisation of medicine

Protelos and Osseor Article-20 procedure: PRAC List of questions

Reference Number: EMA/PRAC/283429/2013

Protelos and Osseor Article-20 procedure: Notification

Protelos and Osseor Article-20 procedure: Review started

Reference Number: EMA/291972/2013

Protelos and Osseor Article-20 procedure: Timetable for the procedure

Reference Number: EMA/PRAC/283428/2013 Rev.1

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

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

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

Reference Number: EMA/112925/2014

Protelos-H-C-560-PSU-0031 : EPAR - Assessment Report – Periodic safety update report

Adopted Reference Number: EMA/PRAC/136656/2013

Protelos-H-C-560-PSU-0031 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Adopted Reference Number: EMA/CHMP/257649/2013

Protelos-H-C-560-II-0031 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/313009/2012

CHMP post-authorisation summary of positive opinion for Protelos

Adopted Reference Number: EMA/313022/2012

Initial marketing authorisation documents

Protelos : EPAR - Scientific Discussion

Protelos : EPAR - Procedural steps taken before authorisation