Gadolinium-containing contrast agents
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
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
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About this medicine
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| Approved name |
Gadolinium-containing contrast agents
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| International non-proprietary name (INN) or common name |
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| Associated names |
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About this procedure
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| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A-31/1097
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| 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. |
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Key dates and outcomes
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| CHMP opinion date |
18/03/2010
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| EC decision date |
01/07/2010
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All documents
Gadolinium H-A-31-1097: Assessment Report (PDF/161.61 KB)
First published: 06/12/2010
Last updated: 06/12/2010
EMA/740640/2010
Gadolinium - Article 31 referral - Annex I, II, III, IV (PDF/481.97 KB)
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.