VAXELIS
STN: 125563
Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine
Tradename: VAXELIS
Manufacturer: MSP Vaccine Company
Indication:
- Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib) in children 6 weeks through 4 years of age (prior to fifth birthday).
Product Information
Supporting Documents
- April 12, 2023 Approval Letter - VAXELIS
- October 27, 2020 Approval Letter - VAXELIS
- September 25, 2020 Approval Letter - VAXELIS
- May 5, 2020 Approval Letter - VAXELIS
- March 23, 2020 Approval Letter - VAXELIS
- December 21, 2018 Approval Letter - VAXELIS
- December 18, 2018 Summary Basis for Regulatory Action - VAXELIS
- Approval History, Letters, Reviews, and Related Documents - VAXELIS
- Clinical Review - VAXELIS
- May 4, 2015 Statistical Review - VAXELIS