Renitec

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

Enalapril is a highly 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-aldosterone system.

From the authorisations in Member States, different Summaries of Product Characteristics (SPC) had been issued, based on national, divergent decisions. On 31 October 2000, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC1.

The referral procedure started on 31 May 2001 in order to harmonise the Summaries of Product Characteristics within the Member States, Norway and Iceland. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH) during the Oral Explanation on 18 September 2002, was of the opinion that the benefit/risk ratio of enalapril is considered to be favourable for use related to hypertension, symptomatic heart failure and prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤35%). The CPMP issued a positive opinion, on 19 September 2002, recommending the harmonisation of the SPC for Renitec and associated names.

The CPMP Opinion dated 19 September 2002 was appealed by the MAH on 15 November 2002. The MAH was invited to an Oral Explanation at the December CPMP meeting, but notified the EMEA of their wish not to attend this hearing.

After consideration of the grounds for appeal submitted by the MAH in their letter of 15 November 2002 and all available data and the discussion that followed within the Committee, the CPMP, during the meeting of 17 – 18 December 2002 recommended that its Opinion of 19 September 2002 should be revised. The agreed indications for Renitec are: treatment of hypertension, treatment of symptomatic heart failure and prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤35%).

The list of product names concerned is given in Annex I. An overall summary of the scientific evaluation of Renitec (and associated names) including the scientific conclusion following the appeal are provided in Annex II together with the amended Summary of Product Characteristics in Annex III.

A Decision was issued by the European Commission on 21 May 2003.

Key facts

Approved name
Renitec
International non-proprietary name (INN) or common name
enalapril
Class
-
Reference number
CPMP/3175/03
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.

Status
European Commission final decision
Opinion date
19/09/2002
EC decision date
21/05/2003

All documents

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.

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