Home Applications 761304 Application 761304
Type BLA
Sponsor ARGENX BV Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761304 Vyvgart Hytrulo efgartigimod alfa and hyaluronidase-qvfc 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYVGART HYTRULO EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC INJECTABLE;INJECTION 1008MG;11200UNITS PER 5.6ML No No
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Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VYVGART Hytrulo EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT) argenx US 7104d9e5-9910-47f5-9a93-741ac50f43b6 2026-07-15 Warnings, Adverse reactions Exact identifier application number: BLA761304
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.