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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:  04/24/2013
 
Trade Name:  Prezista
 
Generic Name or Proper Name (*):  darunavir
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  Revised labeling to include pharmacokinetic, safety, tolerability, and virologic response data from a 48 week study for HIV-1 treatment experienced pediatric patients 3 to < 6 years Additional information on adverse reactions Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Jannsen
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
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