AREPANRIX
STN: 125419
Proper Name: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Tradename: AREPANRIX
Manufacturer: ID Biomedical Corporation of Quebec
Indication:
- AREPANRIX is a vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.
- AREPANRIX is approved for use in individuals 6 months and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
Product Information
Supporting Documents
- October 18, 2024 Approval Letter - AREPANRIX
- Statistical-Clinical Review - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
- Clinical Review - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
- Statistical-Clinical Review - Addendum - Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
- Approval History, Letters, Reviews, and Related Documents - Q-Pan
- Supporting Documents older than three years - Q-Pan