GADOVIST (gadobutrol), paramagnetic contrast agent

High clinical benefit in angiography and magnetic resonance imaging in its diagnostic indications in children aged 0 to 2 years, and minor clinical added value in the current therapeutic strategy.

• GADOVIST has now been granted an MA in children under the age of 2 years, in the same indications as those already defined for children over the age of 2 years and in adults. It should only be used when diagnosis is necessary and when this diagnosis cannot be reached by magnetic resonance imaging (MRI) without contrast enhancement.

• The assessment rests primarily on a study of pharmacokinetic parameters in children under the age of 2 years, relative to children over the age of 2 years and adults.

• Long-term risks associated with gadolinium retention in the brain have been identified by the PRAC, more so for linear products than for macrocyclic products (GADOVIST is a member of this group). Children are thus likely to be more exposed to this risk than adults; this risk should therefore be taken into account considering the possibility of multiple examinations.