Product Approval Information
Proper Name: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Tradename: Prevnar
Manufacturer: Wyeth Pharmaceuticals Inc, License #0003
Package Insert (PDF - 347 KB) - Approved: December 11, 2007
Date: February 17, 2000
Indication: Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease
February 17, 2000 Approval Letter
Clinical Review - Part 1 (PDF-1 MB), Part 2 (PDF-1.2 MB), Part 3 (PDF-1.1 MB), Part 4 (PDF-1 MB), Part 5 (PDF-834 KB)
Statistical Review - Part 1 (PDF-1.5 MB), Part 2 (PDF-1 MB)
SBA (PDF-1.7 MB)
Talk Paper - February 17, 2000
Date: October 1, 2002
Indication: Immunization of infants and toddlers against otitis media caused by vaccine serotypes
October 1, 2002 Approval Letter
Clinical Review (PDF-262 KB)
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