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Cervarix

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Cervarix

Proper name

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

Licence type

351(a)

BLA number

125259

Applicant

GlaxoSmithKline Biologicals

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.5ML	Injection	Intramuscular	Pre-Filled Syringe	Disc	October 16, 2009

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