General MedicationsINTRAVENOUSStandard
ELELYSO
TALIGLUCERASE ALFA
Standard Dose
200 UNITS/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ELELYSO is listed in Drugs@FDA under application 022458 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TALIGLUCERASE ALFA Form and strength POWDER;INTRAVENOUS - 200 UNITS/VIAL Sponsor PFIZER Submission history Latest submission status date: 2025-12-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview ELELYSO is listed in Drugs@FDA under application 022458 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient TALIGLUCERASE ALFA Form and strength POWDER;INTRAVENOUS - 200 UNITS/VIAL Sponsor PFIZER Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.