Lopid

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

Overview

Gemfibrozil is a serum-lipid lowering agent belonging to the family of the non-halogenated phenoxypentanoic acid derivatives.

Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States. On 6 January 2003, the European Commission presented to the EMEA (see Annex 1) a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product Lopid and associated names.

The referral procedure started on 23 January 2003. 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), was of the opinion that the benefit/risk ratio of Lopid is considered to be positive in the following indications:

Lopid is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:

Treatment of dyslipidemia
Mixed dyslipidaemia characterised by hypertriglyceridaemia and/or low HDL-cholesterol. Primary hypercholesterolaemia, particularly when a statin is considered inappropriate or is not tolerated.

Primary prevention
Reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is considered inappropriate or is not tolerated (see section 5.1).

The CPMP gave a positive opinion on 24 March 2004 recommending the harmonisation of the SPC for Lopid 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.

A Decision was issued by the European Commission on 29 July 2004.

Key facts

Approved name
Lopid
International non-proprietary name (INN) or common name
Gemfibrozil
Reference number
CHMP/289490/05
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
24/03/2004
EC decision date
29/07/2004

All documents

Document description

  • 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 takenfor the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating