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Hiberix Approval History

  • FDA approved: Yes (First approved August 19th, 2009)
  • Brand name: Hiberix
  • Generic name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
  • Dosage form: Solution for Intramuscular Injection
  • Company: GlaxoSmithKline
  • Treatment for: Haemophilus influenzae Prophylaxis

Hiberix is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. Hiberix is approved for use in children aged six weeks through four years of age (prior to fifth birthday).

Development History and FDA Approval Process for Hiberix

Jan 14, 2016Approval FDA Approves Expanded Use of GSK Hib Vaccine From Booster Dose To Full Series
Aug 20, 2009Approval FDA Approves GSK's Hib Vaccine, Hiberix

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