Product Information

• Package Insert - Hiberix (PDF - 120KB)

Supporting Documents

• 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
  Press Release: August 19, 2009
• Approval History, Letters, Reviews, and Related Documents - Hiberix

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