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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:  11/15/2019
 
Trade Name:  Harvoni
 
Generic Name or Proper Name (*):  ledipasvir and sofosbuvir
 
Indications Studied:  Treatment of chronic hepatitis C virus infection in patients with severe renal impairment including patients with end stage renal disease on dialysis
 
Label Changes Summary:  *In patients with severe renal impairment, including those requiring dialysis, exposures of the inactive metabolite of sofosbuvir are increased. *• No data are available regarding the safety of Harvoni in pediatric patients with renal impairment. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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