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ABRYSVO

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 RSV in individuals 60 years of age and older.
  • Active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

Product Information

  • Package Insert - ABRYSVO (STN 125769)
  • 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

 

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