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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  03/14/2011
Trade Name:  Gadavist
Generic 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
Therapeutic Category:  Medical imaging
Ages Studied:  2 - 17 years
Study #:  1
Study Type:  Safety/Pharmacokinetic/Tolerability
Study Design:  Open Label/Traditional Pharmacokinetic
No Patients:  140
No Centers:  14
No Countries:  4