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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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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
BPCA(B) and PREA(P):
B, P
Sponsor:
MSP Singapore
Pediatric Exclusivity Granted Date:
02/14/2008
NNPS:
FALSE'
Therapeutic Category:
Antilipemic
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