Tolperisone

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision

Overview

On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of tolperisone. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of tolperisone-containing medicines given orally (by mouth) continue to outweigh their risks, but that their use should be restricted to the treatment of adults with post-stroke spasticity (stiffness). The Committee also recommended that the marketing authorisations for tolperisone-containing medicines given by injection should be revoked throughout the European Union (EU).

After re-examination, the Committee confirmed these recommendations on 18 October 2012.

Key facts

About this medicine
Approved name
Tolperisone
International non-proprietary name (INN) or common name
tolperisone
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1311
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Key dates and outcomes
CHMP opinion date
18/10/2012
EC decision date
21/01/2013

All documents

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Questions and answers on the review of tolperisone-containing medicines (PDF/86.19 KB)


    First published: 22/06/2012
    Last updated: 02/04/2013
    EMA/673365/2012 Rev.1

  • European Commission final decision

  • List item

    Assessment report for tolperisone-containing medicinal products (PDF/292.25 KB)


    First published: 02/04/2013
    Last updated: 02/04/2013
    EMA/753061/2012

  • List item

    Tolperisone Article-31 referral - Annex I (PDF/242.88 KB)


    First published: 02/04/2013
    Last updated: 02/04/2013

  • List item

    Tolperisone Article-31 referral - Annex II (PDF/123.2 KB)


    First published: 02/04/2013
    Last updated: 02/04/2013

  • List item

    Tolperisone Article-31 referral - Annex III (PDF/205.85 KB)


    First published: 02/04/2013
    Last updated: 02/04/2013

  • List item

    Tolperisone Article-31 referral - Annex IV (PDF/66.98 KB)


    First published: 02/04/2013
    Last updated: 02/04/2013

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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