Elucirem - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

gadopiclenol

Opinion

On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Elucirem. The marketing authorisation holder for this medicinal product is Guerbet.

The CHMP adopted an extension to the existing indication as follows:

This medicinal product is for diagnostic use only.

Elucirem is indicated in adults and children from birth aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:

• the brain, spine, and associated tissues of the central nervous system (CNS);
  • the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Elucirem (EMAVR0000249008)

Adopted Reference Number: EMADOC-1700519818-2671019

Key facts

• Name of medicine:
  Elucirem
• EMA product number:
  EMEA/H/C/005626
• Active substance:
  Gadopiclenol
• International non-proprietary name (INN) or common name:
  gadopiclenol
• Therapeutic area (MeSH):
  Magnetic Resonance Imaging
• Anatomical therapeutical chemical (ATC) code:
  V08CA12
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Guerbet
• Date of opinion:
  11/12/2025
• Status:
  Positive