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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:  09/17/2015
 
Trade Name:  Epzicom
 
Generic Name or Proper Name (*):  abacavir sulfate and lamivudine
 
Indications Studied:  Once-daily dosing for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg
 
Label Changes Summary:  *Expanded indication from adults to pediatric patients weighing at least 25kg. *Dosing recommendations in this population are based on the safety and efficacy established in a controlled trial conducted using either the combination of Epivir and Ziagen or Epzicom. *In pediatric patients weighing less than 25 kg, use of abacavir and lamivudine as single products is recommended. *The adverse reactions in pediatric patients are similar to those observed in adults. *Information on dosing, PK, clinical studies.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ViiV Healthcare
 
Therapeutic Category:  Antiviral
 
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