Proper Name: Zoster Vaccine Recombinant, Adjuvanted
Manufacturer: GlaxoSmithKline Biologicals
- SHINGRIX is a vaccine indicated for prevention of herpes zoster (HZ) (shingles):
- in adults aged 50 years and older.
- in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
- Package Insert - SHINGRIX
- Demographic Subgroup Information - Zoster Vaccine Recombinant, Adjuvanted (SHINGRIX)
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.
- Toxicology Review- Shingrix
- Clinical Review Memorandum - Shingrix
- Statistical Review and Evaluation - Shingrix
- July 23, 2021 Approval Letter - SHINGRIX
- March 24, 2021 Approval Letter - SHINGRIX
- May 17, 2019 Approval Letter - SHINGRIX
- September 18, 2018 Approval Letter - SHINGRIX
- October 20, 2017 Approval Letter - SHINGRIX
- October 20, 2017 Summary Basis for Regulatory Action - SHINGRIX
- Approval History, Letters, Reviews, and Related Documents - SHINGRIX