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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:  01/25/2013
 
Trade Name:  Prevnar 13
 
Generic Name or Proper Name (*):  Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) *
 
Indications Studied:  Active immunization for the prevention of invasive pneumococcal disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
 
Label Changes Summary:  See Package Insert for new information on biologics
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Wyeth
 
NNPS:  FALSE
 
Therapeutic Category:  Preventive Vaccine
 
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