Mephatrim - referral

Current status

European Commission final decision

Overview

The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Mephatrim. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisation should be granted in Germany and other concerned Member States of the European Union (Estonia, Lithuania, Latvia, Poland, and Portugal).
The review was carried out under an 'Article 29' referral¹.

A European Commission decision on this opinion will be issued in due course.

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

What is Mephatrim?

Mephatrim is used in patients with ischaemic heart disease, with other medicines, to prevent angina attacks. Ischaemic heart disease is a condition where the heart is receiving less oxygen than usual, often because of a narrowing of the blood vessels that supply the heart (coronary arteries). Angina attacks are sudden pains to the chest, jaw, back, brought on by physical effort and due to problems with the blood flow to the heart).

The active substance in Mephatrim, trimetazidine, is a medicine that acts on the heart. Its exact mechanism of action in ischaemic heart disease is not known.

Mephatrim is a generic medicine based on a reference medicine product authorised in France (Vastarel 35 mg modified-release tablets).

Why was Mephatrim reviewed?

Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda submitted Mephatrim for a decentralised procedure to the German medicines regulatory agency with a view of obtaining a marketing authorisation in this country as well as the Estonia, Lithuania, Latvia, Poland, and Portugal (the concerned Member States). These Member States were not able to reach an agreement. On 23 December 2008, the German medicines regulatory agency referred the matter to the CHMP for arbitration.

The grounds for the referral were that the effectiveness of the reference medicine was not established and that the successful bioequivalence studies carried out with Mephatrim, showing that it produces the same levels of active substance in the body as Vastarel, were not sufficient to show that it was
effective.

What are the conclusions of the CHMP?

Based on the currently available data and the scientific discussion within the Committee, the CHMP concluded that Mephatrim had shown that it is bioequivalent to the reference medicine, and its benefit and risk are taken as being the same as those of the reference medicine. Therefore the marketing authorisation for Mephatrim should be granted in all concerned member states.

The Committee also noted that it was not able in the context of this referral to conclude on the benefitrisk balance of the reference medicine.

Questions and answers on the referral for Mephatrim trimetazidine 35 mg modified-release tablets

AdoptedReference Number: EMEA/45405/2009

Key facts

About this medicine

• Approved name:
  Mephatrim
• International non-proprietary name (INN) or common name:
  trimetazidine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/45405/2009
• 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:
  22/01/2009
• EC decision date:
  19/03/2009

All documents

Questions and answers on the referral for Mephatrim trimetazidine 35 mg modified-release tablets

AdoptedReference Number: EMEA/45405/2009

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.