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General MedicationsSUBCUTANEOUSStandard

EMPAVELI

PEGCETACOPLAN

Standard Dose
1080MG/20ML (54MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview EMPAVELI is listed in Drugs@FDA under application 215014 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGCETACOPLAN Form and strength SOLUTION;SUBCUTANEOUS - 1080MG/20ML (54MG/ML) Sponsor APELLIS PHARMS Submission history Latest submission status date: 2025-07-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMPAVELI is listed in Drugs@FDA under application 215014 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGCETACOPLAN Form and strength SOLUTION;SUBCUTANEOUS - 1080MG/20ML (54MG/ML) Sponsor APELLIS PHARMS Submission history Latest submission status date: 2025-07-28 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.