Product Details for: Revcovi
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
2.4MG/1.5ML (1.6MG/ML)
Single-Dose Vial
351(a)
Revcovi
Rx
Proper Name
elapegademase-lvlr
elapegademase-lvlr
BLA Number
761092
761092
Applicant
Chiesi USA, Inc.
Chiesi USA, Inc.
Original Approval Date
October 5, 2018
October 5, 2018
Date of First Licensure