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General MedicationsINJECTIONStandard

OPUVIZ

AFLIBERCEPT-YSZY

Standard Dose
2MG(0.05ML,40MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OPUVIZ is listed in Drugs@FDA under application 761350 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AFLIBERCEPT-YSZY Form and strength INJECTABLE;INJECTION - 2MG(0.05ML,40MG/ML) Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2026-03-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPUVIZ is listed in Drugs@FDA under application 761350 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient AFLIBERCEPT-YSZY Form and strength INJECTABLE;INJECTION - 2MG(0.05ML,40MG/ML) Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2026-03-19 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.