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General MedicationsINJECTIONStandard

ELAHERE

MIRVETUXIMAB SORAVTANSINE-GYNX

Standard Dose
100mg/20mL single-dose vial
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ELAHERE is listed in Drugs@FDA under application 761310 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MIRVETUXIMAB SORAVTANSINE-GYNX Form and strength INJECTABLE;INJECTION - 100mg/20mL single-dose vial Sponsor IMMUNOGEN INC Submission history Latest submission status date: 2025-07-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview ELAHERE is listed in Drugs@FDA under application 761310 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient MIRVETUXIMAB SORAVTANSINE-GYNX Form and strength INJECTABLE;INJECTION - 100mg/20mL single-dose vial Sponsor IMMUNOGEN INC Submission history Latest submission status date: 2025-07-14 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.