Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Manufacturer: Sanofi Pasteur, SA, License #1724
- 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 25, 2016 Approval Letter - ActHIB(PDF - 32KB)
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(PDF - 31KB)
To update the package insert (PI) and convert it to the Physicians Labeling Rule (PLR) format.
January 14, 2014 Approval Letter-ActHIB
To change the product labeling and revising the age indication.
Summary for Basis of Approval (ActHIB combined with Tripedia) - Tripedia(PDF - 1000KB) March 28, 2013 Approval Letter - ActHIB[ARCHIVED]
To include changes to the package insert.
November 20, 2009 Approval Letter - ActHIB[ARCHIVED]
Package Insert Revised: Regarding formaldehyde levels.
September 27, 1996 Approval Letter - ActHIB[ARCHIVED]
Reconstitution with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, manufactured by Connaught Laboratories, Inc, for immunization of 15-18 month old children.
Summary Basis for Regulatory Action - ActHIB(PDF - 5.6MB)