Product Details for: Vyvgart Hytrulo Product Label Grayed out Product Label links indicate that there is no product label available for the product.
Product Label Grayed out Product Label links indicate that there is no product label available for the product.
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 |
Proper Name
efgartigimod alfa and hyaluronidase-qvfc
BLA Number
761304
Applicant
Argenx BV
Original Approval Date
June 20, 2023
Date of First Licensure