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General MedicationsINJECTIONStandard

TEVIMBRA

islelizumab-jsgr

Standard Dose
10 mg/mL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TEVIMBRA is listed in Drugs@FDA under application 761380 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient islelizumab-jsgr Form and strength INJECTABLE;INJECTION - 10 mg/mL Sponsor BEIGENE Submission history Latest submission status date: 2025-03-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview TEVIMBRA is listed in Drugs@FDA under application 761380 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient islelizumab-jsgr Form and strength INJECTABLE;INJECTION - 10 mg/mL Sponsor BEIGENE Submission history Latest submission status date: 2025-03-03 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
TEVIMBRA (islelizumab-jsgr) | Drug Monograph | MedicHelpline