Coversyl - referral

Current status

European Commission final decision

Overview

Perindopril is a specific, competitive inhibitor of Angiotensin I-Converting Enzyme (ACE), belonging to the category of ACE-inhibitors. The beneficial effects of ACE-inhibitors appear to result primarily from the suppression of the plasma renin-angiotensin-aldosteron system.

Perindopril was initially approved in 1988, for the treatment of hypertension throughout the European Union, Iceland and Norway. From the authorisations in Member States, different Summaries of Product Characteristics (SPC) had been issued, based on national, divergent decisions.

On 6 January 2003, the European Commission referred the matter to the EMEA under Article 30 of Directive 2001/83/EC¹. The referral procedure started on 23 January 2003 in order to resolve divergencies amongst the nationally authorised SPCs and to harmonise the SPCs within the Member States, Norway and Iceland.

The Rapporteur and Co-Rapporteur appointed were: Dr E. Abadie and Pharm. M. Avgerinos, respectively. Written explanations were provided by the Marketing Authorisation Holder on 18 March 2003 and 5 June 2003.

During its July 2003 meeting, the CPMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio of perindopril is considered favourable for treatment of hypertension and symptomatic heart failure and that the SPC should be amended. A positive opinion was therefore adopted on 24 July 2003, recommending the harmonisation of the SPC for Coversyl and associated names.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.

The final opinion was converted into a Decision by the European Commission on 4 December 2003.

¹ Corresponding to Article 11 of Directive 75/319/EEC, for referrals presented before 18 December 2001

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Coversyl and associated names (see Annex I) International Non-Proprietary Name (INN): perindopril: Background information...

Adopted Reference Number: CPMP/32703/03

Key facts

About this medicine

• Approved name:
  Coversyl
• International non-proprietary name (INN) or common name:
  perindopril
• Class:
  -

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/32703/03
• Type:
  Article 30 referrals

  This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Key dates and outcomes

• CHMP opinion date:
  24/07/2003
• EC decision date:
  04/12/2003

All documents

Coversyl - Article 30 referral - Annex I, II, III

Adopted

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Coversyl and associated names (see Annex I) International Non-Proprietary Name (INN): perindopril: Background information...

Adopted Reference Number: CPMP/32703/03

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.