General MedicationsINJECTIONStandard
CEREZYME
IMIGLUCERASE
Standard Dose
400 UNITS/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview CEREZYME is listed in Drugs@FDA under application 020367 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IMIGLUCERASE Form and strength INJECTABLE;INJECTION - 400 UNITS/VIAL Sponsor GENZYME Submission history Latest submission status date: 2026-01-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview CEREZYME is listed in Drugs@FDA under application 020367 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient IMIGLUCERASE Form and strength INJECTABLE;INJECTION - 400 UNITS/VIAL Sponsor GENZYME Submission history Latest submission status date: 2026-01-12 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.