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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:
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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