Английская Википедия:Gadopiclenol
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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][2] Gadopiclenol is a paramagnetic macrocyclic non-ionic complex of gadolinium.[1]
Gadopiclenol was approved for medical use in the United States in September 2022[1][3][4] and in the European Union in December 2023.[5][6]
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][7][8]
Society and culture
Legal status
Gadopiclenol was approved for medical use in the United States in September 2022 by the Food and Drug Administration.[1][9]
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.[10] The applicant for this medicinal product is Guerbet.[10] 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.[11] The applicant for this medicinal product is Bracco Imaging S.p.A.[11] The EMA approved gadopiclenol for medical use in the EU on December 2023.[5][6]
Brand names
Gadopiclenol is the international nonproprietary name.[12]
Gadopiclenol is sold under the brand names Elucirem and Vueway.[5][6]
References
External links
Шаблон:Contrast media Шаблон:Portal bar Шаблон:Authority control
- ↑ 1,0 1,1 1,2 1,3 1,4 Ошибка цитирования Неверный тег
<ref>; для сносокElucirem FDA labelне указан текст - ↑ Шаблон:Cite journal
- ↑ Шаблон:Cite press release
- ↑ Шаблон:Cite web Шаблон:PD-notice
- ↑ 5,0 5,1 5,2 Шаблон:Cite web
- ↑ 6,0 6,1 6,2 Шаблон:Cite web
- ↑ Шаблон:Cite journal
- ↑ Шаблон:Cite journal
- ↑ Шаблон:Cite web
- ↑ 10,0 10,1 Шаблон:Cite web Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ 11,0 11,1 Шаблон:Cite web Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ Шаблон:Cite journal
- Английская Википедия
- MRI contrast agents
- Pyridines
- Heterocyclic compounds with 2 rings
- Carboxylic acids
- Polyols
- Amides
- Gadolinium compounds
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