General MedicationsINJECTIONStandard
ULTOMIRIS
RAVULIZUMAB-CWVZ
Standard Dose
300MG/30ML(10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ULTOMIRIS is listed in Drugs@FDA under application 761108 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient RAVULIZUMAB-CWVZ Form and strength INJECTABLE;INJECTION - 300MG/30ML(10MG/ML) Sponsor ALEXION PHARM Submission history Latest submission status date: 2025-09-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview ULTOMIRIS is listed in Drugs@FDA under application 761108 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient RAVULIZUMAB-CWVZ Form and strength INJECTABLE;INJECTION - 300MG/30ML(10MG/ML) Sponsor ALEXION PHARM Submission history Latest submission status date: 2025-09-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.