AUDENZ
STN: 125692
Proper Name: Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
Tradename: AUDENZ
Manufacturer: Seqirus, Inc.
Indication:
- AUDENZ is an inactivated vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.
- AUDENZ is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
Product Information
- Package Insert - AUDENZ
- Demographic Subgroup Information - AUDENZ
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
- April 24, 2024 Approval Letter - AUDENZ
- November 17, 2021 Approval Letter - AUDENZ
- October 29, 2021 Approval Letter - AUDENZ
- January 31, 2020 Summary Basis for Regulatory Action - AUDENZ
- January 31, 2020 Approval Letter - AUDENZ
- Statistical Review - AUDENZ
- Approval History, Letters, Reviews, and Related Documents - AUDENZ