- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), currently indicated for the treatment of hypertension and symptomatic heart failure. It is licensed in the EU through the Mutual Recognition Procedure (MRP) and was first marketed in France in 1988 as Coversyl 2 and 4 mg. It is currently marketed in the entire European Union and world-wide in more than 10 countries, including USA and Japan.
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the "reduction of risk of cardiovascular events in patients with stable coronary artery disease". At the end of the MRP procedure there was a discrepancy between different MS regarding the wording of the indication that adequately reflects the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by the Netherlands to the CHMP on 17.03.2005.
The arbitration procedure was discussed and initiated by the CHMP at its plenary meeting in April 2005, and a Rapporteur (Dr Gonzalo Calvo Rojas) and Co-Rapporteur (Dr. Gottfried Kreutz) were appointed. The questions identified pertained to the inclusion of a specific group of revascularised patients in the proposed indication, the justification of the beneficial effect of perindopril beyond a mere reduction of myocardial infarction, and an overall justification of the claimed indication based on the results of relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy. The company responded to these points on 20 May 2005.
Based on the evaluation of the currently available data and the (Co-)Rapporteurs' assessment reports, the CHMP adopted an opinion on 27 July 2005 recommending the variation of the Marketing Authorisations for the addition of the following new indication:
Stable coronary artery disease:
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II and the amended Summary of Product Characteristics in Annex III.
The final opinion was converted into a Decision by the European Commission on 7 November 2005.
|International non-proprietary name (INN) or common name||
Article 6(12) referrals (prior to January 2010)
This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.
European Commission final decision
|EC decision date||
Opinion following an Article 6 (12) referral Perindopril tert-butylamine salt International Non-Proprietary Name (INN): Perindopril: Background information (PDF/132.75 KB)Adopted
First published: 08/11/2005
Last updated: 08/11/2005
Coversyl - Article 6 (12) referral - Annex I, II, III (PDF/295.61 KB)Adopted
First published: 22/12/2005
Last updated: 22/12/2005
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies