Product Approval Information

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

Package Insert (PDF - 379 KB) - Approved: June 20, 2008

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Date: June 20, 2008
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)
June 20, 2008 Approval Letter
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents

Updated: July 18, 2008