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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  03/14/2011
 
Trade Name:  Gadavist
 
Generic Name or Proper Name (*):  gadobutrol
 
Indications Studied:  Detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
 
Label Changes Summary:  * Safety and efficacy have been established in children 2 - 17 years* Safety and effectiveness have not been established in children <2 years* Information on dosing, adverse events, pharmacokinetics, and clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Bayer
 
NNPS:  FALSE
 
Therapeutic Category:  Medical imaging
 
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