STN: 125678
Proper Name: Smallpox and Mpox Vaccine, Live, Non-replicating
Tradename: JYNNEOS
Manufacturer: Bavarian Nordic A/S
Indication:
- For prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
Product Information
Supporting Documents
- March 31, 2025 Approval Letter – JYNNEOS
- November 25, 2024 Approval Letter – JYNNEOS
- October 18, 2024 Approval Letter – JYNNEOS
- May 28, 2024 564A expiry extension letter – Jynneos
- September 29, 2023 Approval Letter – JYNNEOS
- March 16, 2023 Approval Letter – JYNNEOS
- March 14, 2023 Approval Letter – JYNNEOS
- September 2, 2022 Approval Letter – JYNNEOS
- June 16, 2021 Approval Letter – JYNNEOS
- June 7, 2021 Approval Letter – JYNNEOS
- September 24, 2019 Summary Basis for Regulatory Action – JYNNEOS
- September 24, 2019 Approval Letter- JYNNEOS
- Approval History, Letters, Reviews, and Related Documents – JYNNEOS
Related Information
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Content current as of:
05/14/2025
