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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:  01/23/2015
 
Trade Name:  BEXSERO
 
Generic Name or Proper Name (*):  Meningococcal Group B Vaccine*
 
Indications Studied:  Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in patients 10 through 25 years of age
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novartis Vaccines and Diagnostics, Inc
 
NNPS:  FALSE
 
Therapeutic Category:  Preventative Vaccine
 
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