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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:
11/29/2007
Trade Name:
Diovan
Generic Name or Proper Name (*):
valsartan
Indications Studied:
Hypertension
Label Changes Summary:
Labeling for 6-16 years of age Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 Information on dose, clinical studies in 1-16 years and pharmacokinetics No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients Information on preparation of a suspension
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
08/08/2007
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
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