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General MedicationsINJECTIONStandard

BKEMV

ECULIZUMAB-AEEB

Standard Dose
300MG/30ML(10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview BKEMV is listed in Drugs@FDA under application 761333 (BLA).

Review priority: N/A Marketing status: Prescription Active ingredient ECULIZUMAB-AEEB Form and strength INJECTABLE;INJECTION - 300MG/30ML(10MG/ML) Sponsor AMGEN INC Submission history Latest submission status date: 2026-03-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview BKEMV is listed in Drugs@FDA under application 761333 (BLA). Review priority: N/A Marketing status: Prescription Active ingredient ECULIZUMAB-AEEB Form and strength INJECTABLE;INJECTION - 300MG/30ML(10MG/ML) Sponsor AMGEN INC Submission history Latest submission status date: 2026-03-26 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.