Fibrates

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

Overview

The European Medicines Agency has completed a review of the safety and effectiveness of fibrates. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of fibrates continue to outweigh their risks but that they should not be used as 'first line' in the treatment of blood lipid (fat) disorders, such as high cholesterol, except in rare cases. This means that newly diagnosed patients with blood lipid disorders should not be treated using these medicines in the first instance, unless they have very high levels of triglycerides (a type of fat). However, fibrates can be used in patients who cannot take statins (another type of medicine used to lower blood lipid levels).

Key facts

About this medicine
Approved name
Fibrates
International non-proprietary name (INN) or common name
  • bezafibrate
  • ciprofibrate
  • fenofibrate
  • gemfibrozil
Associated names
  • Bezalip
  • Lipanor
  • Lipanthyl
  • Lopid
Class
fibrates
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/001238
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Key dates and outcomes
CHMP opinion date
21/10/2010
EC decision date
28/02/2011

All documents

European Commission final decision

  • List item

    Questions and answers on the review of medicines containing fibrates (PDF/59.75 KB)

    Adopted

    First published: 22/10/2010
    Last updated: 03/04/2013
    EMA/643808/2010 Rev. 1

  • List item

    Assessment report for fenofibrate-, bezafibrate-, ciprofibrate- and gemfibrozil-containing medicinal products (PDF/256.97 KB)

    Adopted

    First published: 03/04/2013
    Last updated: 03/04/2013
    EMA/CHMP/580013/2012

  • List item

    Fibrates Article-31 referral - Annex I (PDF/2.18 MB)


    First published: 03/04/2013
    Last updated: 03/04/2013

  • List item

    Fibrates Article-31 referral - Annex II (PDF/62.14 KB)


    First published: 03/04/2013
    Last updated: 03/04/2013

  • List item

    Fibrates Article-31 referral - Annex III (PDF/140.18 KB)


    First published: 03/04/2013
    Last updated: 03/04/2013

  • List item

    Fibrates (bezafibrate, ciprofibrate, fenofibrate and gemfibrozil) - Article-31 referral - changes to product information (PDF/78.02 KB)

    Adopted

    First published: 22/10/2010
    Last updated: 22/10/2010

  • 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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