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Gadopiclenol
MRI contrast agent From Wikipedia, the free encyclopedia
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Gadopiclenol, sold under the brand name Elucirem among others, is a contrast agent used with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and in the body.[1][6] Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.[1]
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Gadopiclenol was approved for medical use in the United States in September 2022,[1][7][8] and in the European Union in December 2023.[2][3][4][5]
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Pharmacology
Gadopiclenol has a higher relaxivity compared with standard gadolinium-based contrast agents (GBCAs). The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administered to the patient while preserving imaging quality. Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. This is half the dose of standard macrocyclic GBCAs, which have a recommended dose of 0.1 mmol/kg.[1][9][10]
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Legal status
Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.[1][11]
In October 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Elucirem, intended for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and, visualization of pathologies when diagnostic information is essential and not available with unenhanced MRI.[2] The applicant for this medicinal product is Guerbet.[2] In October 2023, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vueway, intended for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and, visualization of pathologies when diagnostic information is essential and not available with unenhanced MRI.[4] The applicant for this medicinal product is Bracco Imaging S.p.A.[4] Gadopiclenol was approved for medical use in the European Union in December 2023.[2][3][4][5]
Brand names
Gadopiclenol is the international nonproprietary name.[12]
Gadopiclenol is sold under the brand names Elucirem and Vueway.[2][3][4][5]
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External links
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