Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Manufacturer: GlaxoSmithKline Biologicals
- For active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 6 weeks through 4 years of age (prior to fifth birthday).
January 14, 2016 Approval Letter - HIBERIX(PDF - 41KB)
To include safety and effectiveness data to support the use of Hiberix for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children 6 weeks to 14 months of age, revisions to product labeling.
January 14, 2016 Summary Basis for Regulatory Action - HIBERIX(PDF - 128KB) January 14, 2016 Clinical Review - HIBERIX(PDF - 676KB) January 14, 2016 Statistical Review - HIBERIX(PDF - 680KB) March 12, 2012 Approval Letter - Hiberix - ARCHIVED
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 - ARCHIVED
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 - ARCHIVED
Includes revised labeling to address the presence of latex in the tip caps of the pre-filled syringes containing diluent.
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[ARCHIVED]