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. |
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