Product Details for: Gamifant

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
10MG/2ML (5MG/ML)
Single-Dose Vial
351(a)
Gamifant
Rx
002
Injection
Intravenous
50MG/10ML (5MG/ML)
Single-Dose Vial
351(a)
Gamifant
Rx
003
Injection
Intravenous
100MG/20ML (5MG/ML)
Single-Dose Vial
351(a)
Gamifant
Rx
004
Injection
Intravenous
50MG/2ML (25MG/ML)
Single-Dose Vial
351(a)
Gamifant
Rx
005
Injection
Intravenous
100MG/4ML (25MG/ML)
Single-Dose Vial
351(a)
Gamifant
Rx
006
Injection
Intravenous
250MG/10ML (25MG/ML)
Single-Dose Vial
351(a)
Gamifant
Rx
Proper Name
emapalumab-lzsg
BLA Number
761107
Applicant
Swedish Orphan Biovitrum AB (publ)
Original Approval Date
November 20, 2018
Date of First Licensure
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