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).
- 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