HIBERIX

STN: 125347 Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Tradename: HIBERIX Manufacturer: GlaxoSmithKline Biologicals S.A. Indication: HIBERIX is a vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday). Product Information Package Insert - HIBERIX Supporting Documents December 17, 2025 Approval Letter - HIBERIX December 20, 2023 Approval Letter - HIBERIX April 30, 2018 Approval Letter - Hiberix To include safety and effectiveness data. April 27, 2018 Summary Basis for Regulatory Action - Hiberix January 14, 2016 Clinical Review - HIBERIX January 14, 2016 Statistical Review - HIBERIX Approval History, Letters, Reviews, and Related Documents - Hiberix Supporting Documents older than three years - Hiberix