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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:  03/23/2015
 
Trade Name:  Epivir
 
Generic Name or Proper Name (*):  lamivudine
 
Indications Studied:  HIV
 
Label Changes Summary:  * Labeling revised to provide for once-daily dosing in pediatric patients 3 months of age *Information on clinical trial *New dosing
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  ViiV Healthcare
 
Therapeutic Category:  Antiviral
 
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