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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:
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
PREA(P):
P
Sponsor:
ViiV Healthcare
NNPS:
FALSE
Therapeutic Category:
Antiviral
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