gadopiclenol

FDA Drug Profile — ELUCIREM

Drug Details

Generic Name
gadopiclenol
Brand Names
ELUCIREM
Application Number
NDA216986
Sponsor
Guerbet LLC
NDC Codes
9
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
GADOPICLENOL

Indications and Usage

1 INDICATIONS AND USAGE ELUCIREM is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ELUCIREM is a gadolinium-based contrast agent indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues), the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). ( 1 )