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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:
04/10/2006
Trade Name:
Lescol & Lescol XL
Generic Name or Proper Name (*):
fluvastatin
Indications Studied:
Heterozygous familial hypercholesterolemia as an adjunct to diet
Label Changes Summary:
New indication in adolescent boys and girls (at least one year post-menarche) 10-16 years of age, with heterozygous familial hypercholesterolemia Information on dose, AE profile and clinical studies
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
12/15/2005
NNPS:
FALSE'
Therapeutic Category:
Antilipemic
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