AREXVY
STN: 125775
Proper Name: Respiratory Syncytial Virus Vaccine, Adjuvanted
Tradename: AREXVY
Manufacturer: GlaxoSmithKline Biologicals SA
Indication:
- AREXVY is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:
- individuals 60 years of age and older;
- individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV
Product Information
- 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.
Supporting Documents
- June 7, 2024 Approval Letter - AREXVY
- May 23, 2023 Approval Letter - AREXVY
- May 3, 2023 Summary Basis for Regulatory Action - AREXVY
- Approval History, Letters, Reviews, and Related Documents - AREXVY