Vaccines, Blood & Biologics
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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
Indication:
- For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday)
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Supporting Documents
July 27, 2012 Approval Letter - PENTACEL
To include the addition of safety information to the Warnings and Precautions section of the package insert regarding the risk of apnea in premature infants.- July 19, 2012 Summary Basis for Regulatory Action - PENTACEL (PDF - 74KB)
July 15, 2011 Approval Letter - PENTACEL
To include changes to the package insert regarding the dosage and administration claim.- July 12, 2011 Summary Basis for Regulatory Action - PENTACEL (PDF - 53KB)
December 22, 2009 Approval Letter - Pentacel
To revise the labeling to comply with the Physician's Labeling Rule format.June 20, 2008 Approval Letter - Pentacel
For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday.Summary Basis for Regulatory Action - Pentacel Approval History, Letters, Reviews, and Related Documents - Pentacel
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