Glucophage/Glucophage Forte/Risidon/Dianben - referral

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.

Summary information on a referral opinion following an arbitration pursuant to Article 11 of Council Directive 75/319/EEC as amended, for Glucophage/Glucophage Forte/Risidon/Dianben International Non-Proprietary Name (IN...

Adopted Reference Number: CPMP/4082/00

Key facts

About this medicine

• Approved name:
  Glucophage/Glucophage Forte/Risidon/Dianben
• International non-proprietary name (INN) or common name:
  metformin

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  19/10/2000
• EC decision date:
  06/02/2001

All documents

Summary information on a referral opinion following an arbitration pursuant to Article 11 of Council Directive 75/319/EEC as amended, for Glucophage/Glucophage Forte/Risidon/Dianben International Non-Proprietary Name (IN...

Adopted Reference Number: CPMP/4082/00

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.