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Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Manufacturer: GlaxoSmithKline Biologicals, S.A.
- For active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b when administered as a booster dose in children 15 months through 4 years of age (prior to fifth birthday).
March 12, 2012 Approval Letter - Hiberix
To include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information.
December 16, 2010 Approval Letter - Hiberix
Includes revisions to the product labeling to instruct providers, following reconstitution, to withdraw the entire contents of the vial (approximately 0.5mL) and administer via intramuscular injection.
December 10, 2010 Approval Letter - Hiberix
Includes revised labeling to address the presence of latex in the tip caps of the pre-filled syringes containing diluent.
Dear Health Care Provider Letter: Dosage And Administration Change For Hiberix® [Haemophilus B Conjugate Vaccine (Tetanus Toxoid Conjugate)](PDF - 103KB)
December 16, 2010
Dear Health Care Provider Letter: Information Re: Hiberix (Haemophilus B Conjugate Vaccine [Tetanus Toxoid Conjugate]) Tip Caps Of The Prefilled Diluent Syringes May Contain Natural Rubber Latex Which May Cause Allergic Reactions In Latex Sensitive Individuals
July 29, 2010
August 19, 2009 Approval Letter - Hiberix
For active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b when administered as a booster dose in children 15 months through 4 years of age (prior to fifth birthday).
Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply[ARCHIVED]
Press Release: August 19, 2009
Approval History, Letters, Reviews, and Related Documents - Hiberix