Is Gadopiclenol approved by the US FDA?

Drugs@FDA lists 1 application product line for Gadopiclenol, including ELUCIREM (Prescription).

Is Gadopiclenol authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Gadopiclenol: Elucirem, Vueway.

Are there safety signals or safety updates for Gadopiclenol?

US FDA: 1 entry (latest 2026-02-20).

Active substance

Gadopiclenol

US FDA 1
EMA 2
Health Canada 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ELUCIREM	1.4553GM/3ML (485.1MG/ML); 3.63825GM/7.5ML (485.1MG/ML); 4.851GM/10ML (485.1MG/ML); 7.2765GM/15ML (485.1MG/ML); 14.553GM/30ML (485.1MG/ML); 24.255GM/50ML (485.1MG/ML); 48.51GM/100ML (485.1MG/ML)	solution · intravenous	GUERBET	Prescription	21 Sep 2022

EMA European Union — centrally authorised medicines

Elucirem Guerbet · Authorised · authorised 7 Dec 2023 · ATC V08CA12

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only.Elucirem is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Vueway Bracco Imaging S.p.A. · Authorised · authorised 7 Dec 2023 · ATC V08CA12

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only.Vueway is indicated in adults and children from birth for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:- the brain, spine, and associated tissues of the central nervous system (CNS);- the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VUEWAY	02567334	485.1 MG / ML	SOLUTION · INTRAVENOUS	BRACCO IMAGING CANADA

Safety signals and safety-related labeling changes

US FDA 20 Feb 2026 ELUCIREM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for gadopiclenol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.