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.
Gadolinium-containing contrast agents
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.
European Commission final decision
|EC decision date||
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
Gadolinium H-A-31-1097: Assessment Report (PDF/161.61 KB)
First published: 06/12/2010
Last updated: 06/12/2010
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
- 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