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          JYNNEOSVaccines, Blood & Biologics JYNNEOS
  
  	
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    Print**STN:** 125678**Proper Name:**Smallpox and Monkeypox Vaccine, Live, Non-Replicating**Tradename:** JYNNEOS**Manufacturer:**Bavarian Nordic **Indication:**

For prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.Product Information

Package Insert - JYNNEOS
	Demographic Subgroup Information - JYNNEOS
	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

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

                                                                                  Content current as of:
      10/02/2023
              
              
Regulated Product(s)
		 BiologicsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
          Blood Donor Screening
          Cellular & Gene Therapy Products
          Development & Approval Process (CBER)
          Guidance, Compliance & Regulatory Information (Biologics)
          International Activities
          News & Events (Biologics)
          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
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