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Vaccines, Blood & Biologics
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Resources for You
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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 (pneuled021700r2a.pdf) (PDF - 1038KB)
Part 1 - Clinical Review of New Product License Application PLA 92-079 Prenar (pneuled021700r2b.pdf) (PDF - 1274KB)
Part 2 - Clinical Review of New Product License Application PLA 92-079 Prenar (pneuled021700r2c.pdf) (PDF - 1156KB)
Part 3 - Clinical Review of New Product License Application PLA 92-079 Prenar (pneuled021700r2d.pdf) (PDF - 1051KB)
Part 4 - Clinical Review of New Product License Application PLA 92-079 Prenar (pneuled021700r2e.pdf) (PDF - 833KB)
Part 5 - Statistical Review and Evaluation (pneuled021700r1a.pdf) (PDF - 1561KB)
Part 1 - Statistical Review and Evaluation (pneuled021700r1b.pdf) (PDF - 1064KB)
Part 2 - Summary For Basis of Approval (Prevnar) (PDF - 1709KB)
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