Product Details for: Epysqli

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
300MG/30ML (10MG/ML)
Single-Dose Vial
351(k) Interchangeable
Epysqli
Rx
Proper Name
eculizumab-aagh
Reference Product Proper Name
eculizumab
Reference Product Properietary Name
Soliris
BLA Number
761340
Applicant
Samsung Bioepis Co., Ltd.
Original Approval Date
July 19, 2024
Date of First Licensure
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