gadobenate dimeglumine

FDA Drug Profile — MultiHance

gadobenate dimeglumine is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including MultiHance. Available dosage forms: powder, injection, solution.

Drug Details

Generic Name
gadobenate dimeglumine
Brand Names
MultiHance
Application Number
NDA021357
Sponsor
BRACCO IMAGING SPA
NDC Codes
3
Dosage Forms
POWDER, INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
GADOBENATE DIMEGLUMINE

Indications and Usage

1 INDICATIONS AND USAGE magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues (1.1) magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease. (1.2) 1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) MultiHance is indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. 1.2 Magnetic Resonance Angiography (MRA) of Renal and Aorto-ilio-femoral Vessels MultiHance is indicated for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.