• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  06/05/2008
 
Trade Name:  Zetia and Vytorin
 
Generic Name or Proper Name (*):  ezetimibe and ezetimibe/ simvastatin
 
Indications Studied:  Heterozygous familial hypercholesterolemia as an adjunct to diet
 
Label Changes Summary:  * The effects of ezetimibe co-administered with simvastatin compared to simvastatin monotherapy have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH)
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  MSP Singapore
 
Pediatric Exclusivity Granted Date:  02/14/2008
 
NNPS:  FALSE
 
Therapeutic Category:  Antilipemic
 
-
-