Product Details for: Vyvgart Hytrulo
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML)
Single-Dose Vial
351(a)
Vyvgart Hytrulo
Rx
002
Injection
Subcutaneous
1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML)
Pre-Filled Syringe
351(a)
Vyvgart Hytrulo
Rx
Proper Name
efgartigimod alfa and hyaluronidase-qvfc
efgartigimod alfa and hyaluronidase-qvfc
BLA Number
761304
761304
Applicant
Argenx BV
Argenx BV
Original Approval Date
June 20, 2023
June 20, 2023
Date of First Licensure