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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:  11/21/2017
 
Trade Name:  Triumeq
 
Generic Name or Proper Name (*):  abacavir, dolutegravir, and lamivudine
 
Indications Studied:  Treatment of HIV-1 infection in patients weighing at least 40 kg
 
Label Changes Summary:  *Clinical data supporting use of Triumeq in HIV-1 infected pediatric patients weighing at least 40 kg is derived from previously conducted pediatric trials using the individual components of Triumeq. *Triumeq is a fixed-dose combination tablet which cannot be adjusted for patients weighing less than 40 kg. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ViiV Healthcare
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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