Glucophage/Glucophage Forte/Risidon/Dianben

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

Overview

Glucophage/Glucophage Forte/Risidon/Dianben (metformin) contains the active substance metformin which is an oral antihyperglycaemic agent. Two strengths (500 mg and 850 mg) are registered in all Member States of the European Union, except in Finland where there is only the 500 mg strength and in Greece and Spain, where there is only the 850 mg strength.

In all Member States, national licenses have been originally granted from 1959 to 1997. From these registrations, different Summaries of Product Characteristics have been issued, based on national, divergent decisions. In particular, the therapeutic indications differed significantly.

On 17 May 2000, Lypha Santé acting on behalf of all the Marketing Authorisation Holders presented to the EMEA a referral under Article 11 of Council Directive 75/319/EEC as amended, in order to harmonise the Summaries of Product Characteristics within the Member States. A proposal of Summary of Product Characteristics based on an updated dossier was provided.

The referral procedure started on 29 June 2000. The basis for this arbitration procedure was a harmonisation of the Summaries of Product Characteristics. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, Scientific discussion within the Committee and comments from the Marketing Authorisation Holders, was of the opinion that the benefit/risk ratio of metformin is considered to be favourable for the agreed indications. The CPMP issued a positive opinion, on 19 October 2000, recommending the harmonisation of the Summaries of Product Characteristics for Glucophage/Glucophage Forte/Risidon/Dianben.

An overall summary of the scientific evaluation is provided, together with the amended Summaries of Product Characteristics.

A Decision was issued by the European Commission on 6 February 2001.

Key facts

Approved name
Glucophage/Glucophage Forte/Risidon/Dianben
International non-proprietary name (INN) or common name
metformin
Reference number
CPMP/4082/00
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
19/10/2000
EC decision date
06/02/2001

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

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