Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Manufacturer: Sanofi Pasteur, SA
- ActHIB vaccine is indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive disease caused by H influenzae type b.
- May 24, 2019 Approval Letter - ActHIB
- December 20, 2018 Approval Letter - ActHIB
- May 25, 2016 Approval Letter - ActHIB
To replace buildings as the facility for the formulation and filling of the 0.4% Sodium Chloride Injection Diluent, as well as associated changes in the manufacture of the Diluent and in the product labeling for ActHIB.
- December 16, 2015 Approval Letter - ActHIB
To update the package insert (PI) and convert it to the Physicians Labeling Rule (PLR) format.
- Supporting Documents older than three years - ActHIB