gadoteridol

FDA Drug Profile — ProHance

Drug Details

Generic Name
gadoteridol
Brand Names
ProHance
Application Number
NDA020131
Sponsor
BRACCO DIAGNOSTICS INC
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
GADOTERIDOL

Indications and Usage

1 INDICATIONS AND USAGE ProHance is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates ( 1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.2 MRI of Extracranial/Extraspinal Head and Neck ProHance is indicated for MRI in adults to visualize lesions in the head and neck.