Product Details for: QIVIGY

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Solution
Intravenous
5G/50ML
Single-Dose Vial
351(a)
QIVIGY
Rx
002
Solution
Intravenous
10G/100ML
Single-Dose Vial
351(a)
QIVIGY
Rx
Proper Name
Immune Globulin Intravenous, Human-kthm, 10% Solution
BLA Number
125822
Applicant
Kedrion, S.p.A.
Original Approval Date
September 26, 2025
Date of First Licensure
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