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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
09/20/2017
Trade Name:
Rapivab
Generic Name or Proper Name (*):
peramivir
Indications Studied:
Treatment of acute uncomplicated influenza in patients 2 years and older
Label Changes Summary:
*Expanded the patient population to include the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days based on clinical studies of 110 adolescent and pediatric patients. *Information on s dosing, adverse reactions, PK parameters, and clinical trials.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
BioCryst Pharmaceuticals, Inc.
NNPS:
FALSE
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