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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:
12/16/2011
Trade Name:
Prezista
Generic Name or Proper Name (*):
darunavir
Indications Studied:
Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg
Label Changes Summary:
Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and olderDo not use in pediatric patients < 3 years of ageInformation on dosing, adverse reactions, pharmacokinetics and clinical trialNew formulation
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Tibotec
Pediatric Exclusivity Granted Date:
06/07/2011
NNPS:
FALSE'
Therapeutic Category:
Antiviral
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