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General MedicationsSINGLE-USEStandard

ELFABRIO

PEGUNIGALSIDASE ALFA-IWXJ

Standard Dose
20MG/10ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview ELFABRIO is listed in Drugs@FDA under application 761161 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGUNIGALSIDASE ALFA-IWXJ Form and strength VIAL; SINGLE-USE - 20MG/10ML Sponsor CHIESI FARMACEUTICI SPA Submission history Latest submission status date: 2023-05-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview ELFABRIO is listed in Drugs@FDA under application 761161 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient PEGUNIGALSIDASE ALFA-IWXJ Form and strength VIAL; SINGLE-USE - 20MG/10ML Sponsor CHIESI FARMACEUTICI SPA Submission history Latest submission status date: 2023-05-09 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.