General MedicationsSOLUTIONStandard
EPYSQLI
ECULIZUMAB-AAGH
Standard Dose
300 mg/30 mL (10 mg/mL)
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary
Approval overview EPYSQLI is listed in Drugs@FDA under application 761340 (BLA).
Review priority: N/A Marketing status: Prescription Active ingredient ECULIZUMAB-AAGH Form and strength INJECTION;SOLUTION - 300 mg/30 mL (10 mg/mL) Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2026-01-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview EPYSQLI is listed in Drugs@FDA under application 761340 (BLA). Review priority: N/A Marketing status: Prescription Active ingredient ECULIZUMAB-AAGH Form and strength INJECTION;SOLUTION - 300 mg/30 mL (10 mg/mL) Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2026-01-23 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: N/A
Interaction Notes
- No interaction notes stored yet.