Vaccines, Blood & Biologics
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ActHIB
STN: 103935
Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Tradename: ActHIB
Manufacturer: Sanofi Pasteur, SA, License #1724
Indication: ActHIB vaccine or ActHIB vaccine combined with Sanofi Pasteur Inc. DTP vaccine by reconstitution is indicated for the active immunization of infants and children 2 through 18 months of age for the prevention of invasive disease caused by H influenzae type b and/or diphtheria, tetanus and pertussis
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Supporting Documents
November 20, 2009 Approval Letter - ActHIB
Package Insert Revised: Regarding formaldehyde levels.September 27, 1996 Approval Letter - ActHIB
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 for Basis of Approval (ActHIB combined with Tripedia) - Tripedia (PDF - 1000KB)Summary Basis for Regulatory Action - ActHIB (PDF - 5.6MB)
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