Approval History, Letters, Reviews, and Related Documents - Pentacel

Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Tradename: Pentacel
Manufacturer: Sanofi Pasteur Limited, License #1726
STN: 125145/0
Approval Date: 6/20/2008

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Approval information/letter/labeling

Memorandum/Reviews

• Summary Basis for Regulatory Action

   

• Clinical Review (PDF - 1.4 MB)
• Clinical: Review of Methods for Pertussis Clinical Serology (PDF - 452 KB)
• Evaluation of Proposed Proprietary Name Pentacel
• Immunogenicity Review (PDF - 1.5 MB)
• Post Licensure Safety Surveillance Study of Routine Use of Pentacel (PDF - 250 KB)
• Product Review of Haemophilus Component and Serology (PDF - 387 KB)
• Recommendations Regarding Request for Partial Waiver of Pediatric Studies
• Review of CMC and Serology of Diphtheria and Tetanus Toxoids (PDF - 222 KB)
• Statistical Review and Evaluation (PDF - 188 KB)
• Surveillance for Rates of Hib Disease Among Persons Aged 0-4 Years Receiving Pentacel or Other Hib Vaccines (PDF - 374 KB)
• Surveillance for Rates of Pertussis Disease Among Persons Aged 0-4 Years Receiving Pentacel or Other Pertussis Vaccines (PDF - 279 KB)
• 6/17/2008 Memo (PDF - 92 KB)
• 5/20/2008 Review Memo
• 2/26/2007 Review Memo (PDF - 200 KB)
• 2/20/2007 Review Memo (PDF - 211 KB)
• 2/14/2007 Review Memo
• 11/27/2006 Review Memo (PDF - 355 KB)
• 4/7/2006 Review Memo (PDF - 411 KB)
• 3/27/2006 Review Memo (PDF - 1.8 MB)

Administrative Documents

• Officer/Employee List

Correspondence

• 5/16/2008 Fax (PDF - 151 KB)
• 9/11/2007 Teleconference (PDF - 186 KB)
• 6/8/2007 Letter (PDF - 201 KB)
• 6/7/2007 Letter
• 5/18/2007 Meeting Minutes (PDF - 196 KB)
• 4/23/2007 Letter
• 5/26/2006 Letter (PDF - 1.6 MB)

 

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