Gadoteridol Injection Reference Listed Drug

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Generic Name	Gadoteridol Injection
Brand Name	ProHance
Dosage Form	Injection
Strength	279.3mg/mL（1.3965 g/5mL） 279.3mg/mL（2.793 g/10mL） 279.3mg/mL（4.1895 g/15mL） 279.3mg/mL（5.586 g/20mL） 279.3mg/mL（13.965 g/50mL）
MAH of Product	Bracco Diagnostics Inc
Note 1	Original drug not imported to China
Note 2	US Orange Book
Product Type	Reference Listed Drugs (RLDs)

 

Gadoteridol Injection 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. It is also indicated for MRI in adults to visualize lesions in the head and neck.

 

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