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General MedicationsIV (INFUSION)Standard

SOLIRIS

ECULIZUMAB

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

Approval overview SOLIRIS is listed in Drugs@FDA under application 125166 (BLA).

Review priority: N/A Marketing status: Prescription Active ingredient ECULIZUMAB Form and strength INJECTABLE; IV (INFUSION) - 300MG Sponsor ALEXION PHARM Submission history Latest submission status date: 2025-06-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOLIRIS is listed in Drugs@FDA under application 125166 (BLA). Review priority: N/A Marketing status: Prescription Active ingredient ECULIZUMAB Form and strength INJECTABLE; IV (INFUSION) - 300MG Sponsor ALEXION PHARM Submission history Latest submission status date: 2025-06-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.