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Arexvy

Respiratory Syncytial Virus Vaccine, Adjuvanted

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Arexvy

Proper name

Respiratory Syncytial Virus Vaccine, Adjuvanted

Licence type

351(a)

BLA number

125775

Applicant

GlaxoSmithKline Biologicals

Center

CBER

Presentations

First licensure

May 3, 2023

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
120UG/.5ML	For Injection	Intramuscular	Single-Dose Vial	Rx	May 3, 2023

Purple Book	FDA	Licence type, presentations, reference product, exclusivity