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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:  12/18/2008
 
Trade Name:  Prezista
 
Generic Name or Proper Name (*):  darunavir
 
Indications Studied:  Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents
 
Label Changes Summary:  Extended indication from adults to pediatric patients 6 years and older Safety and effectiveness in pediatric patients 3 to < 6 years of age have not been established Do not administer in pediatric patients below 3 years of age Do not administer Prezista/rtv once daily in pediatric patients Dosing for patients 6 to < 18 years and weighing at least 44 lbs (20 kg) is based on body weight not to exceed adult dose AE similar to those seen in adults Information on dose, Aes, PK parameters, lab abnormalities, and clinical study
 
Product Labeling:  Labeling  Opens a new window
 
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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