Clopidogrel Orion - 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 Clopidogrel Orion and associated names.

The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Orion outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden.

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

What is Clopidogrel Orion?

Clopidogrel Orion is a medicine that contains the active substance clopidogrel. It is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as a heart attack or stroke.

The active substance, clopidogrel, is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming. When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together). Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface. This stops the platelets becoming 'sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.

Clopidogrel Orion is a generic medicine based on a 'reference medicine', Plavix, which is authorised in the EU.

Why was Clopidogrel Orion reviewed?

Teva Pharma B.V. submitted Clopidogrel Orion to Germany for a decentralised procedure. This is a procedure where one Member State (the 'reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the 'concerned Member States', in this instance the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden).

As the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.

The grounds for the referral were concerns from Sweden that patients would be exposed to the antioxidant butylated hydroxyanisole (BHA) unnecessarily. The company had chosen to use 'clopidogrel base' as the form of the active substance in the medicine, and not a salt such as the 'hydrogen sulfate salt' used in Plavix. Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it.

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 Clopidogrel Orion outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States.

The European Commission issued a decision on 2 June 2010.

Questions and answers on Clopidogrel Orion and associated names (clopidogrel 75 mg tablets)

Adopted Reference Number: EMA/106818/2010

Key facts

About this medicine

• Approved name:
  Clopidogrel Orion
• International non-proprietary name (INN) or common name:
  clopidogrel

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1247
• 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:
  18/02/2010
• EC decision date:
  02/06/2010

All documents

Clopidogrel Orion - Article 29 Referral - Annex I, II, III

Adopted

Questions and answers on Clopidogrel Orion and associated names (clopidogrel 75 mg tablets)

Adopted Reference Number: EMA/106818/2010

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.