STN#: 125145
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
Indication:

• Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b.

Product Information

• Package Insert – Pentacel - (inactivated poliovirus component grown in MRC-5 cells)
• Package Insert – Pentacel - (inactivated poliovirus component grown in Vero cells)

 

Supporting Documents

• 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