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Purple Book
Database of Licensed Biological Products

Product Details for: Vyvgart Hytrulo
Product Label Grayed out Product Label links indicate that there is no product label available for the product.

Product NumberDosage FormRoute of AdministrationStrengthProduct PresentationLicense TypeProprietary NameMarketing Status
001Injection Subcutaneous1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML)Single-Dose Vial351(a)Vyvgart HytruloRx

Proper Name
efgartigimod alfa and hyaluronidase-qvfc

BLA Number
761304

Applicant
Argenx BV

Original Approval Date
June 20, 2023

Date of First Licensure