• 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:  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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Merck
 
Pediatric Exclusivity Granted Date:  03/20/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
-
-