Reason for request

Extension of indication


Clinical Benefit


the actual benefit of the proprietary medicinal products MULTIHANCE 10, 15 and 20 mL, solution for injection (vials and pre-filled syringes), is substantial in “MRI of the breast, for the detection of malignant lesions in patients where breast cancer is known or suspected on the basis of previous mammography or ultrasonography results.”

Clinical Added Value


MULTIHANCE provides a minor improvement in actual benefit (IAB IV) in terms of diagnostic performance in breast MRI by comparison with MAGNEVIST.