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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/19/2019
 
Trade Name:  Conjupri
 
Generic Name or Proper Name (*):  levamlodipine
 
Indications Studied:  Hypertension in adults and pediatric patients 6 years and older
 
Label Changes Summary:  *Indicated in patients 6 to 17 years. *Effect of levamlodipine on blood pressure in patients less than 6 years of age is not known. *Information on dosing, PK parameters, and clinical trials. *New active ingredient.
 
PREA(P):  P
 
Sponsor:  CSPC Ouyi Pharmaceutical Co., Ltd.
 
NNPS:  FALSE
 
Therapeutic Category:  Antihypertensive
 
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