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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:
03/11/2004
Trade Name:
Cozaar
Generic Name or Proper Name (*):
losartan
Indications Studied:
Hypertension
Label Changes Summary:
Antihypertensive effects established in hypertensive patients 6-16 years of age Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/ min/1.73 m2 due to no data Information on PK and dose in pediatric patients 6-16 years of age. No relevant differences between the AE profile for pediatric patients compared to reported AEs for adults Information on preparation of a suspension
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Merck
Pediatric Exclusivity Granted Date:
03/20/2002
NNPS:
FALSE'
Therapeutic Category:
Antihypertensive
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