AREPANRIX

STN: 125419
Proper Name: Influenza A [H5] Monovalent Vaccine, Adjuvanted
Tradename: AREPANRIX
Manufacturer: GlaxoSmithKline Biologicals SA
Indication:

• AREPANRIX is a vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5 subtype contained in the vaccine.
• AREPANRIX is approved for use in individuals aged 6 months and older at increased risk of exposure to the influenza A virus H5 subtype contained in the vaccine.

Product Information

• Package Insert - AREPANRIX

Supporting Documents

• April 28, 2026 Approval Letter - AREPANRIX
• 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

Related Information

• Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, manufactured by ID Biomedical Corporation - Questions and Answers