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Qivigy

Immune Globulin Intravenous, Human-kthm, 10% Solution

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Qivigy

Proper name

Immune Globulin Intravenous, Human-kthm, 10% Solution

Licence type

351(a)

BLA number

125822

Applicant

Kedrion, S.p.A.

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
10G/100ML	Solution	Intravenous	Single-Dose Vial	Rx	September 26, 2025
5G/50ML	Solution	Intravenous	Single-Dose Vial	Rx	September 26, 2025

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