On this page

Jynneos

Smallpox and Mpox Vaccine, Live, Non-replicating

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Jynneos

Proper name

Smallpox and Mpox Vaccine, Live, Non-replicating

Licence type

351(a)

BLA number

125678

Applicant

Bavarian Nordic A/S

Center

CBER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
0.5-3.95 X 10E8 INF. U/.5ML	Injection	Subcutaneous	Single-Dose Vial	Rx	September 24, 2019
0.5-3.95 X 10E8 INF. U/.5ML	For Injection	Subcutaneous	Single-Dose Vial	Rx	March 21, 2025

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