Product Details for: Ultomiris

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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(a)
Ultomiris
Rx
002
Injection
Intravenous
300MG/3ML (100MG/ML)
Single-Dose Vial
351(a)
Ultomiris
Rx
003
Injection
Intravenous
1,100MG/11ML (100MG/ML)
Single-Dose Vial
351(a)
Ultomiris
Rx
004
Injection
Subcutaneous
245MG/3.5ML (70MG/ML)
Single-Dose Cartridge
351(a)
Ultomiris
Rx
Proper Name
ravulizumab-cwvz
BLA Number
761108
Applicant
Alexion Pharmaceuticals, Inc.
Original Approval Date
December 21, 2018
Date of First Licensure
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