Product Details for: Saphnelo

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
120MG/0.8ML
Pre-Filled Syringe
351(a)
Saphnelo
Rx
002
Injection
Subcutaneous
120MG/0.8ML
Autoinjector
351(a)
Saphnelo
Rx
Proper Name
anifrolumab-fnia
BLA Number
761451
Applicant
AstraZeneca AB
Original Approval Date
April 24, 2026
Date of First Licensure
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