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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:  06/26/2015
 
Trade Name:  Kaletra
 
Generic Name or Proper Name (*):  lopinavir/ ritonavir
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  * Kaletra should not be administered once daily in pediatric patients. * A multicenter, open-label study evaluated the efficacy and safety of twice-daily versus once-daily dosing of Kaletra tablets dosed by weight in 173 virologically suppressed HIV-1 infected children. * New dosing regimen, postmarketing study.
 
PREA(P):  P
 
Sponsor:  AbbVie Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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