Guerbet receives EMA acceptance of EluciremTMas the Brand Name for Gadopiclenol
2022-06-13
药物审批
Villepinte (France), June 13 2022 (8:30 CET) – Guerbet (FR0000032526 GBT), a global leader in medical imaging, announces today that EluciremTM, 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 EluciremTMas 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.
适应症
-靶点
-
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。