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

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

Content current as of:

03/13/2026

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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