Listen
PRIMOVIST (acide gadoxetique) - Magnetic resonance imaging (MRI)
Reason for request
Summary of opinion
Favourable opinion for reimbursement in the MA indication:
“PRIMOVIST is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI).
PRIMOVIST should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI) and when delayed phase imaging is required.
This medicinal product is for diagnostic use by intravenous administration only.”
No clinical added value of the new pre-filled plastic syringe forms compared to the pre-filled glass syringe forms already available.
Clinical Benefit
| Substantial |
The clinical benefit of PRIMOVIST 0.25 mmol/mL (gadoxetic acid) solution for injection in pre-filled syringe (plastic) is substantial in the MA indication. |
Clinical Added Value
| no clinical added value |
PRIMOVIST 0.25 mmol/mL (gadoxetic acid) solution for injection in pre-filled syringe (plastic) is a range supplement that provides no clinical added value (CAV V) compared to the forms already listed (glass). |
