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Ixiaro

Japanese Encephalitis Vaccine, Inactivated, Adsorbed

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ixiaro

Proper name

Japanese Encephalitis Vaccine, Inactivated, Adsorbed

Licence type

351(a)

BLA number

125280

Applicant

Valneva Austria GmbH

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	Rx	March 30, 2009

Source: Purple Book

Kind	Expires
Orphan exclusivity	May 17, 2020

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