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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:  02/01/2013
 
Trade Name:  Prezista
 
Generic Name or Proper Name (*):  darunavir
 
Indications Studied:  Treatment of HIV-1 infection
 
Label Changes Summary:  *Revised labeling to include once daily dosing in treatment naïve and treatment experienced HIV-1 infected pediatric patients 3 to < 18 years and weighing at least 10 kg * Postmarketing study
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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