Application Nr Approved Date Route Status External Links
NDA021037 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Magnevist Is A Gadolinium-Based Contrast Agent Indicated For Intravenous Use In Diagnostic Mri In Adults And Children (2 Years Of Age And Older) To Facilitate The Visualization Of Lesions And Abnormal Vascularity In: • Central Nervous System: Brain, Spine And Associated Tissues ( 1.1 ) • Extracranial/extraspinal Tissues: Head And Neck ( 1.2 ) • Body ( 1.3 ) 1.1 Central Nervous System Magnevist Injection Is Indicated For Use With Magnetic Resonance Imaging (Mri) In Adults, And Pediatric Patients (2 Years Of Age And Older) To Visualize Lesions With Abnormal Vascularity In The Brain (Intracranial Lesions), Spine And Associated Tissues. Magnevist Injection Has Been Shown To Facilitate Visualization Of Intracranial Lesions Including But Not Limited To Tumors. 1.2 Extracranial/extraspinal Tissues Magnevist Injection Is Indicated For Use With Mri In Adults And Pediatric Patients (2 Years Of Age And Older) To Facilitate The Visualization Of Lesions With Abnormal Vascularity In The Head And Neck. 1.3 Body Magnevist Injection Is Indicated For Use In Mri In Adults And Pediatric Patients (2 Years Of Age And Older) To Facilitate The Visualization Of Lesions With Abnormal Vascularity In The Body.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Gadopentetate Dimeglumine

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