Protelos: Withdrawal of the application to change the marketing authorisation

strontium ranelate

Overview

On 21 March 2014, Les Laboratoires Servier officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications to extend the indication of Protelos/Osseor to include the treatment of osteoarthritis of the knee and hip.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Protelos (strontium ranelate) (PDF/90.84 KB)


    First published: 23/05/2014
    Last updated: 23/05/2014
    EMA/232003/2014

  • Key facts

    Name
    Protelos
    Product number
    EMEA/H/C/000560
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    21/09/2004
    International non-proprietary name (INN) or common name
    • strontium ranelate
    Active substance
    • strontium ranelate
    Date of withdrawal
    21/03/2014
    Company making the application
    Les Laboratoires Servier
    Withdrawal type
    Post-authorisation

    All documents

    Related information on withdrawals

    The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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