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Gamifant

emapalumab-lzsg

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Gamifant

Proper name

emapalumab-lzsg

Licence type

351(a)

BLA number

761107

Applicant

Swedish Orphan Biovitrum AB (publ)

Center

CDER

Presentations

6

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG/20ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	June 26, 2020
100MG/4ML (25MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	June 7, 2023
10MG/2ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	November 20, 2018
250MG/10ML (25MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	June 7, 2023
50MG/10ML (5MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	November 20, 2018
50MG/2ML (25MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	June 7, 2023

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 20, 2025

Sources for this page

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