General MedicationsIV (INFUSION)Standard
LUMIZYME
ALGLUCOSIDASE ALFA
Standard Dose
5MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview LUMIZYME is listed in Drugs@FDA under application 125291 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ALGLUCOSIDASE ALFA Form and strength POWDER; IV (INFUSION) - 5MG/ML Sponsor GENZYME Submission history Latest submission status date: 2024-12-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview LUMIZYME is listed in Drugs@FDA under application 125291 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALGLUCOSIDASE ALFA Form and strength POWDER; IV (INFUSION) - 5MG/ML Sponsor GENZYME Submission history Latest submission status date: 2024-12-30 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.