Product Details for: Spevigo
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
450MG/7.5ML (60MG/ML)
Single-Dose Vial
351(a)
Spevigo
Rx
002
Injection
Subcutaneous
150MG/ML
Pre-Filled Syringe
351(a)
Spevigo
Rx
003
Injection
Subcutaneous
300MG/2ML (150MG/ML)
Pre-Filled Syringe
351(a)
Spevigo
Rx
Proper Name
spesolimab-sbzo
spesolimab-sbzo
BLA Number
761244
761244
Applicant
LEO Pharma A/S
LEO Pharma A/S
Original Approval Date
September 1, 2022
September 1, 2022
Date of First Licensure