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General MedicationsINJECTIONStandard

REVCOVI

ELAPEGADEMASE-LVLR

Standard Dose
1.6MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview REVCOVI is listed in Drugs@FDA under application 761092 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ELAPEGADEMASE-LVLR Form and strength INJECTABLE;INJECTION - 1.6MG/ML Sponsor CHIESI USA INC Submission history Latest submission status date: 2020-12-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview REVCOVI is listed in Drugs@FDA under application 761092 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ELAPEGADEMASE-LVLR Form and strength INJECTABLE;INJECTION - 1.6MG/ML Sponsor CHIESI USA INC Submission history Latest submission status date: 2020-12-05 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.