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General MedicationsINJECTIONStandard

VYVGART HYTRULO

EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC

Standard Dose
1008MG;11200UNITS PER 5.6ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview VYVGART HYTRULO is listed in Drugs@FDA under application 761304 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC Form and strength INJECTABLE;INJECTION - 1008MG;11200UNITS PER 5.6ML Sponsor ARGENX BV Submission history Latest submission status date: 2026-02-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview VYVGART HYTRULO is listed in Drugs@FDA under application 761304 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC Form and strength INJECTABLE;INJECTION - 1008MG;11200UNITS PER 5.6ML Sponsor ARGENX BV Submission history Latest submission status date: 2026-02-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC) | Drug Monograph | MedicHelpline