European Commission Approves New Pediatric Indication for Elucirem™ (Gadopiclenol) from Guerbet

New Pediatric Indication for Elucirem™ (Gadopiclenol)



On January 27, 2026, Guerbet, a global leader in medical imaging and contrast media, proudly announced that the European Commission has granted approval for the use of Elucirem™ (gadopiclenol) in pediatric patients from birth. This marks a significant milestone, especially for children's healthcare, as Elucirem™ is now recognized for its efficacy in magnetic resonance imaging (MRI) procedures aimed at enhancing the visualization of various medical conditions while minimizing gadolinium exposure.

A Revolutionary Contrast Agent


Elucirem™ was initially approved in the EU in December 2023, making it the first gadolinium-based contrast agent with high relaxivity. Unlike other agents, Elucirem™ can be administered at half the dose traditionally required, addressing a primary concern regarding the safety of gadolinium exposure for patients, particularly vulnerable populations such as infants and children. This breakthrough innovation allows clinicians to perform MRIs using less gadolinium without compromising image quality.

Enhancing Patient Care


The newly approved indication for children from birth is a testament to Guerbet's commitment to improving patient safety while fostering medical innovation. According to Valérie Brissart, Senior Vice President of Imaging at Guerbet, this approval will empower European radiologists to conduct contrast-enhanced MRIs with Elucirem™ using only half the typical dose. This is invaluable for young patients who may require multiple MRIs throughout their lives, as it significantly reduces cumulative gadolinium exposure.

Dr. Emilio José Inarejos Clemente, a prominent pediatric radiologist from Hospital Sant Joan de Déu in Barcelona, highlighted that Elucirem™'s superior relaxivity allows for outstanding image quality with reduced gadolinium dosage. This is especially critical for young, developing patients where minimizing exposure to any potentially harmful substances is essential. He stated, "The ability to achieve high-quality imaging with a lower volume of gadolinium is a significant advancement for pediatric care."

How Elucirem™ Addresses Clinical Needs


Elucirem™ is indicated for MRI visualization of the brain, spine, and associated central nervous system tissues, as well as in various other organs including the liver, kidneys, pancreas, breast, lungs, prostate, and musculoskeletal system. This wide-ranging applicability underscores the importance of gadopiclenol in medical diagnostics. The agent's capacity to provide detailed images while limiting the volume of gadolinium injected makes it an attractive option for healthcare providers.

About Guerbet


With a legacy of innovation spanning nearly a century, Guerbet is dedicated to building lasting relationships aimed at enabling better lives. The company is a leader in medical imaging, offering a comprehensive portfolio of pharmaceutical products, medical devices, and digital solutions, with continuous commitment to research and development.

Guerbet's dedication to healthcare is evident, as they invest heavily in R&D, allocating 9% of their income to this purpose. They operate globally, with production facilities in France and the USA, emphasizing the intelligent design and efficacy of their imaging agents.

Partnership and Future Directions


Guerbet collaborates with Bracco Imaging, which started in December 2021, to enhance the research, development, and manufacturing of gadopiclenol. This partnership focuses on ensuring broader access to innovative imaging solutions while maintaining high-quality standards for patient care. Both companies hold valuable patents related to gadopiclenol, reflecting their intertwined expertise and commitment to innovation.

In conclusion, the new pediatric indication for Elucirem™ represents a significant advance in the field of medical imaging, particularly in pediatric healthcare. By enabling safer imaging practices and addressing the critical needs of young patients, Guerbet continues to lead the way in innovation for medical imaging technologies.

Topics Health)

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