gadobutrol
gadobutrol is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand names including gadobutrol, Gadavist. Available dosage form: injection.
Drug Details
- Generic Name
- gadobutrol
- Brand Names
- gadobutrol, Gadavist
- Application Number
- ANDA219287
- Sponsor
- Viwit Pharmaceutical Co., Ltd.
- NDC Codes
- 17
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- GADOBUTROL
Indications and Usage
1 INDICATIONS AND USAGE GADAVIST is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) GADAVIST is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients including term neonates To assess the presence and extent of malignant breast disease in adult patients To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) ( 1 )