Renitec

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.