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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:  04/07/2017
 
Trade Name:  Harvoni
 
Generic Name or Proper Name (*):  ledipasvir and sofosbuvir
 
Indications Studied:  Treatment of chronic hepatitis C virus genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis in pediatric patients 12 years of age and older or weighing at least 35 kg
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 12 years and older or weighing at least 35 kg. *Safety, pharmacokinetics, and efficacy for treatment of HCV genotype 1 infection in treatment-naïve and treatment-experienced pediatric patients 12 years of age and older without cirrhosis or with compensated cirrhosis have been established in an open-label, multicenter clinical trial. *Safety and efficacy have not been established in pediatric patients less than 12 years and weighing less than 35 kg, in pediatric patients with decompensated cirrhosis, or in pediatric liver transplant recipients. *Adverse reactions were similar to those observed in adults. *Information on dosing, clinical trial, and PK
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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