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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/17/2010
 
Trade Name:  MultiHance Injection
 
Generic or Proper Name (*):  gadobenate dimeglumine
 
Indications Studied:  Intravenous use in magnetic resonance imaging
 
Therapeutic Category:  Diagnostic aid
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label
 
No Patients:  94
 
No Centers:  17
 
No Countries:  6
 
BPCA(B), PREA(P):  P
 
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