Myderison - referral

Current status

European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Myderison. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Myderison do not outweigh its risks, and the marketing authorisation granted in Hungary cannot be recognised in other Member States of the EU. The marketing authorisation in Hungary should also be revocated.

The review was carried out under an 'Article 29' referral¹.

 

¹ Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

What is Myderison?

Myderison is a medicine that is used to treat skeletal muscle spasticity (stiffness of voluntary muscles).
The active substance in Myderison, tolperisone, is a centrally acting muscle relaxant. The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid. By reducing these impulses, tolperisone is expected to reduce muscle contraction, helping to relieve the stiffness.

Why was Myderison reviewed?

Meditop Pharmaceutical Co. Ltd submitted Myderison for mutual recognition on the basis of the initial authorisation granted by Hungary on 28 March 2006. The company wanted the authorisation to be recognised in the Czech Republic, Germany, Lithuania, Poland and Slovakia (the concerned Member States). However, the Member States were not able to reach an agreement and the Hungarian medicines regulatory agency referred the matter to the CHMP for arbitration on 20 December 2008.

The grounds for the referral were that the medicine did not meet the 'well established use' criteria. These are criteria a company can use to obtain access to the market for medicines where the active substance has been in used for a number of years, and the company can rely on published literature to support their application for marketing authorisation. In this instance, the concerns were that:

• efficacy and safety had not been sufficiently demonstrated;
• the company had not presented sufficient information on the way the medicine is dealt with by the body (pharmacokinetics);
• the dosing recommended in the prescribing information had not been adequately documented nor justified;
• interactions with other medicines had not been adequately evaluated in pre-clinical and clinical studies.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Myderison do not outweigh its risks, and therefore the marketing authorisation should not be granted in the concerned Member States. In addition the Committee also required that the marketing authorisation for Myderison in Hungary should be revocated.

The European Commission issued a decision on 09 August 2010.

Questions and answers on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg

Adopted Reference Number: EMEA/CHMP/675340/2009

Key facts

About this medicine

• Approved name:
  Myderison
• International non-proprietary name (INN) or common name:
  tolperisone hydrochloride

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/675340/2009
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  22/10/2009
• EC decision date:
  06/08/2010

All documents

Myderison - Article 29 referral - Annex I

Myderison - Article 29 referral - Annex II

Questions and answers on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg

Adopted Reference Number: EMEA/CHMP/675340/2009

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.