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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:  01/31/2020
 
Trade Name:  AUDENZ
 
Generic Name or Proper Name (*):  Influenza A (H5N1) Monovalent Vaccine, Adjuvanted*
 
Indications Studied:  Active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine in persons 6 months and older
 
Label Changes Summary:  See Package Insert for new information on biologics
 
PREA(P):  P
 
Sponsor:  Seqirus, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Preventive Vaccine
 
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