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General MedicationsINJECTIONStandard

GAMIFANT

EMAPALUMAB-LZSG

Standard Dose
50MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GAMIFANT is listed in Drugs@FDA under application 761107 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EMAPALUMAB-LZSG Form and strength INJECTABLE;INJECTION - 50MG/10ML Sponsor NOVIMMUNE S.A.

Structured Monograph

Clinical summary

Approval overview GAMIFANT is listed in Drugs@FDA under application 761107 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient EMAPALUMAB-LZSG Form and strength INJECTABLE;INJECTION - 50MG/10ML Sponsor NOVIMMUNE S.A. Submission history Latest submission status date: 2026-03-17 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.