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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:  06/09/2016
 
Trade Name:  Tivicay
 
Generic Name or Proper Name (*):  dolutegravir
 
Indications Studied:  Treatment naïve or treatment experienced INSTI-naïve pediatrics patients weighing at least 30 kg to less than 40 kg
 
Label Changes Summary:  *Expanded the indication to pediatrics patients weighing at least 30 kg; previously approved in 12 years and older weighing at least 40 kg * Safety and efficacy have not been established in pediatric patients weighing less than 30 kg or in any pediatric patients who are INSTI-experienced *Adverse reactions were similar to those observed in adults *Information on dosing, PK, and adverse reactions *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ViiV Healthcare
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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