Reason for request

Renewal of inclusion

-


Clinical Benefit

Substantial

The actual benefit of DOTAREM remains substantial.


Clinical Added Value

minor

DOTAREM offers a minor improvement in actual benefit (level IV) in terms of safety over gadolinium-based contrast media presenting a high (OMNISCAN, MAGNEVIST) or moderate (MULTIHANCE) risk of nephrogenic systemic fibrosis according to the European Medicines Agency classification.