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          ABRYSVOVaccines, Blood & Biologics ABRYSVO
  
  	
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    Print**STN:** 125769; 125768**Proper Name:**Respiratory Syncytial Virus Vaccine**Tradename:**ABRYSVO**Manufacturer:**Pfizer Inc.**Indication:**

ABRYSVO is a vaccine indicated for

Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.
	Active immunization for the prevention of LRTD caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.Product Information

Package Insert - ABRYSVO (STN 125769/26)
	Package Insert - ABRYSVO (STN 125768)
	Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO)
	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.
	Demographic Subgroup Information – Respiratory Syncytial Virus Vaccine (ABRYSVO) (STN 125768)
	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 12, 2023 Summary Basis for Regulatory Action - ABRYSVO (STN 125768)
	August 21, 2023 Approval Letter - ABRYSVO (STN 125769/26)
	August 21, 2023 Approval Letter - ABRYSVO (STN 125768)
	May 31, 2023 Approval Letter - ABRYSVO
	May 31, 2023 Summary Basis for Regulatory Action - ABRYSVO
	Approval History, Letters, Reviews, and Related Documents - ABRYSVO
	Approval History, Letters, Reviews, and Related Documents - ABRYSVO (STN 125768)

                                                                                  Content current as of:
      09/14/2023
              
              
Regulated Product(s)
		 BiologicsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
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          International Activities
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          Resources for You (Biologics)
          Safety & Availability (Biologics)
          Science & Research (Biologics)
          Tissue & Tissue Products
          Vaccines
          Xenotransplantation
 
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