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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:  10/13/2017
 
Trade Name:  Pegays
 
Generic Name or Proper Name (*):  peginterferon alfa-2a
 
Indications Studied:  Treatment of non-cirrhotic pediatric patients 3 years of age and older with HBeAg-positive Chronic Hepatitis B virus infection
 
Label Changes Summary:  *Use for the treatment of pediatric patients 3 to 17 years of age with CHB is based on one clinical trial in 161 previously untreated CHB subjects 3 to 17 years of age of whom 111 were assigned to treatment with PEGASYS. *PEGASYS has not been studied in pediatric CHB patients with liver cirrhosis and the safety and efficacy in pediatric patients with CHB below the age of 3 years have not been established. *Growth inhibition was observed in CHB pediatric patients 3 to 17 years of age during therapy with PEGASYS lasting up to 48 weeks. *Adverse reactions observed in 3-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Hoffman- LaRoche
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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