Product Details for: Arexvy
RETURN TO SEARCH RESULTS
PRODUCT LABEL
Grayed out Product Label links indicate that there is no product label available for the product.
Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intramuscular
120UG/.5ML
Single-Dose Vial
351(a)
Arexvy
Rx
Proper Name
Respiratory Syncytial Virus Vaccine, Adjuvanted
Respiratory Syncytial Virus Vaccine, Adjuvanted
BLA Number
125775
125775
Applicant
GlaxoSmithKline Biologicals
GlaxoSmithKline Biologicals
Original Approval Date
May 3, 2023
May 3, 2023
Date of First Licensure
05/03/2023
05/03/2023