Vaccines, Blood & Biologics
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Prevnar
Proper Name: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Tradename: Prevnar
Manufacturer: Wyeth Pharmaceuticals Inc, License #0003
Indications:
- Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease.
- Immunization of infants and toddlers against otitis media caused by vaccine serotypes.
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Supporting Documents
October 1, 2002 Approval Letter - Prevnar
Indication: Immunization of infants and toddlers against otitis media caused by vaccine serotypes.Clinical Review of Amendment to Product License Application (STN #10031) (PDF - 262KB)February 17, 2000 Approval Letter
Indication: Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease.Clinical Review of New Product License Application PLA 92-079 Prenar (pneuled021700r2b.pdf) (PDF - 1.2MB)
Part 2Clinical Review of New Product License Application PLA 92-0279 - Prevnar (PDF - 1.1MB)Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Clinical Review - Prevnar (PDF - 1.3MB)Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Clinical Review (PDF - 852KB)Statistical Review and Evaluation - Prenar 7, February 13, 2000 (PDF - 1.6MB)Individual Study Table - Prevnar 7 (PDF - 1.3MB)Summary for Basis of Approval - Prevar 7, January 15, 2003 (PDF - 2MB)Clinical Review PLA 92 99-0279 - Prevnar (PDF - 1.2MB)
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