Gadolinium-containing contrast agents

  • 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 risk of nephrogenic systemic fibrosis (NSF) in patients receiving gadolinium-containing contrast agents. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that a number of measures need to be introduced into the prescribing information for these medicines, to minimise the risk of NSF associated with their use.

The European Commission issued a decision on 1 July 2010.

Key facts

About this medicine
Approved name
Gadolinium-containing contrast agents
International non-proprietary name (INN) or common name
  • gadodiamide
  • gadopentetic acid
  • gadobenic acid
  • gadoxetic acid
  • gadoteridol
  • gadobutrol
  • gadoteric acid
Associated names
  • Omniscan
  • Magnevist
  • Magnegita
  • Gado-MRT ratiopharm
  • Primovist
  • MultiHance
  • Dotarem
  • ProHance
  • Gadovist
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1097
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
18/03/2010
EC decision date
01/07/2010

All documents

  • List item

    Questions and answers on the review of gadolinium-containing contrast agents (PDF/48.93 KB)

    Adopted

    First published: 21/11/2009
    Last updated: 02/09/2010
    EMEA/727399/2009

  • List item

    Gadolinium H-A-31-1097: Assessment Report (PDF/161.61 KB)


    First published: 06/12/2010
    Last updated: 06/12/2010
    EMA/740640/2010

  • List item

    Gadolinium - Article 31 referral - Annex I, II, III, IV (PDF/481.97 KB)

    Adopted

    First published: 01/09/2010
    Last updated: 01/09/2010
    Doc. Ref. EMEA/727399/2009 Annex

  • 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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