Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
  • Print
  • Share
  • E-mail
-
 
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
 
BPCA(B), PREA(P):  P
 
-
-