HIBERIX
STN: 125347
Proper Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Tradename: HIBERIX
Manufacturer: GlaxoSmithKline Biologicals S.A.
- 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).
- 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