General MedicationsINJECTIONStandard
KANUMA
SEBELIPASE ALFA
Standard Dose
20MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview KANUMA is listed in Drugs@FDA under application 125561 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient SEBELIPASE ALFA Form and strength INJECTABLE;INJECTION - 20MG/10ML Sponsor ALEXION PHARM Submission history Latest submission status date: 2024-07-10 00:00:00.
Structured Monograph
Clinical summary
Approval overview KANUMA is listed in Drugs@FDA under application 125561 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient SEBELIPASE ALFA Form and strength INJECTABLE;INJECTION - 20MG/10ML Sponsor ALEXION PHARM Submission history Latest submission status date: 2024-07-10 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.