Product Details for: Leqembi

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
200MG/2ML (100MG/ML)
Single-Dose Vial
351(a)
Leqembi
Rx
002
Injection
Intravenous
500MG/5ML (100MG/ML)
Single-Dose Vial
351(a)
Leqembi
Rx
Proper Name
lecanemab-irmb
BLA Number
761269
Applicant
Eisai, Incorporated
Original Approval Date
January 6, 2023
Date of First Licensure