Bracco Imaging S.p.A., a diagnostic imaging company, has received approval from the European Commission (EC) to extend the marketing authorisation of Vueway (gadopiclenol) to paediatric patients below two years of age, including neonates. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Vueway is a next-generation macrocyclic Gadolinium-Based Contrast Agent (GBCA) used in contrast-enhanced Magnetic Resonance Imaging (MRI) to improve the detection and visualisation of various pathologies. The product is currently approved in 36 countries worldwide.

In the European Union, Vueway was initially approved in December 2023 for adults and children aged two years and above. It is indicated for contrast-enhanced MRI of the brain, spine and central nervous system, as well as the liver, kidney, pancreas, breast, lung, prostate and musculoskeletal system. The latest approval expands its use to infants and young children, reinforcing its established safety profile and diagnostic performance.

The CHMP adopted a positive opinion for the extension on December 11, 2025, based on clinical evidence supporting Vueway’s efficacy and safety in very young patients. Vueway is characterised by high stability and the highest longitudinal relaxivity (r1) among approved GBCAs, enabling effective imaging at a lower gadolinium dose.

Large, multicentre clinical studies have demonstrated that Vueway delivers comparable diagnostic performance at half the gadolinium dose of gadobutrol, a widely used contrast agent. Lower-dose imaging reduces patient exposure to gadolinium, a key clinical consideration, particularly for vulnerable populations.

Commenting on the approval, Alberto Spinazzi, Chief Medical and Regulatory Officer at Bracco Group, highlighted the importance of minimising gadolinium exposure while maintaining diagnostic accuracy, especially in neonates and young children whose tissues are still developing.