Proper Name: Respiratory Syncytial Virus Vaccine, Adjuvanted
Manufacturer: GlaxoSmithKline Biologicals SA
- For active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older.
- Package Insert - AREXVY
- Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine, Adjuvanted (AREXVY)
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.
- May 23, 2023 Approval Letter - AREXVY
- May 3, 2023 Summary Basis for Regulatory Action - AREXVY
- Approval History, Letters, Reviews, and Related Documents - AREXVY