Pentacel

STN#: 125145
Proper Name: Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
Tradename: PENTACEL
Manufacturer: Sanofi Pasteur Limited
Indication:

• Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5th birthday).

Product Information

• Package Insert – Pentacel

Supporting Documents

•  March 12, 2026 Approval Letter - Pentacel
• October 21, 2022 Approval Letter - Pentacel
• July 21, 2022 Approval Letter - Pentacel
• February 17, 2021 Approval Letter - Pentacel
• December 19, 2019 Approval Letter - Pentacel
• June 11, 2019 Approval Letter - Pentacel
• March 16, 2017 Approval Letter- PENTACEL
  To revise the package insert (PI) to correct the description of the IPV analytical method, and to remove the word "vaccine" when it follows proprietary names of vaccines throughout the PI.
• Approval History, Letters, Reviews, and Related Documents - Pentacel
• Supporting Documents older than three years - Pentacel