VILLEPINTE, France, June 13,
2022 /PRNewswire/ -- Guerbet (EuronextParis: GBT)
(ISIN: FR0000032526), a global leader in medical imaging, announces
today that Elucirem™, the proposed Guerbet
brand name for Gadopiclenol, has been accepted by the European
Medicines Agency (EMA). Gadopiclenol is an investigational
macrocyclic gadolinium-based contrast agent.
"We are very pleased with the acceptance of
Elucirem™ as the brand name for
Gadopiclenol. This meaningful step forward aligns with our
preparation for its future commercialization in Europe, if approved." said David Hale, Chief Executive Officer of Guerbet
Group.
Guerbet announced on the 24th of February 2022 the acceptance of EMA to review the
Gadopiclenol Centralized Application for Marketing
Authorization.
About Gadopiclenol
Gadopiclenol is an investigational macrocyclic gadolinium-based
contrast agent for MRI developed by Guerbet's Research &
Development team. The efficacy and safety of Gadopiclenol have been
evaluated as part of the company's clinical development plan with a
view to obtain worldwide marketing authorization. No regulatory
authority has evaluated the clinical study data for this product to
date. Details on Phase III clinical trials are available on the
www.ClinicalTrials.gov.
- Efficacy and Safety of Gadopiclenol for Central Nervous System
(CNS) Magnetic Resonance Imaging (MRI) - Full Text View -
ClinicalTrials.gov
- Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance
Imaging (MRI) Full Text View -gov
About Guerbet
At Guerbet, we build lasting relationships so that we enable
people to live better. That is our purpose. We are a global leader
in medical imaging, offering a comprehensive range of
pharmaceutical products, medical devices, and digital and AI
solutions for diagnostic and interventional imaging. As pioneers in
contrast products for 95 years, with more than 2,600 employees
worldwide, we continuously innovate and devote 8%-10% of our
revenue to research and development in five centers in France, Israel, and the
United States. Guerbet (GBT) is listed on Euronext Paris
(segment B – mid caps) and generated €732 million in revenue in
2021. For more information, please visit www.guerbet.com.
Forward-looking statements
This press release may contain statements of a forward-looking
nature, based on assumptions and predictions made by the management
of the Guerbet group. Various known and unknown risks,
uncertainties and other factors could lead to marked differences
between the future results, financial situation, development and
performance of the company, and the estimates made here. These
factors include those mentioned in the public reports of Guerbet,
available on its website www.guerbet.com. The company assumes no
responsibility whatsoever in relation to the updating of these
forward-looking statements, or how they correspond to future events
or developments.
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