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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:
12/18/2008
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
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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