STN: 125737
Proper Name: Hepatitis B Vaccine (Recombinant)
Tradename: PREHEVBRIO
Manufacturer:  VBI Vaccines (Delaware) Inc.
Indication:

• For prevention of infection caused by all known subtypes of the hepatitis B virus in adults 18 years and older.

Product Information

• Package Insert - PREHEVBRIO
• Demographic Subgroup Information – Hepatitis B Vaccine (Recombinant) - PREHEVBRIO
  Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

• November 30, 2021 Approval Letter - PREHEVBRIO
• November 30, 2021 Summary Basis for Regulatory Action - PREHEVBRIO
• Approval History, Letters, Reviews, and Related Documents - PREHEVBRIO