MULTIHANCE (gadobenic acid), paramagnetic contrast agent

Opinions on drugs - Posted on Jan 11 2019

Reason for request

Extension of indication

High clinical benefit in liver magnetic resonance imaging in children over the age of 2 years and minor clinical added value relative to other contrast agents.

  •  MULTIHANCE has now been granted an MA in paediatrics for children ≥ 2 years for liver magnetic resonance imaging (MRI). It should only be used when diagnosis is necessary and when this diagnosis cannot be reached by magnetic resonance imaging (MRI) without contrast enhancement.
  • In July 2017, a PRAC report confirmed that gadolinium accumulated in larger amounts and for longer periods of time when linear rather than macrocyclic contrast agents were used. The MA for MULTIHANCE, a linear product, was restricted to use in liver imaging.

  • The only available data are pharmacokinetic studies, that concluded that systemic exposure and maximum concentrations were similar in children over the age of 2 years and adults, requiring no change in the existing dosage according to body weight to achieve the same efficacy.



Clinical Benefit



Clinical Added Value



Therapeutic use