General MedicationsINJECTIONStandard
BYOOVIZ
RANIBIZUMAB-NUNA
Standard Dose
0.5MG(10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview BYOOVIZ is listed in Drugs@FDA under application 761202 (BLA).
Review priority: STANDARD Marketing status: Prescription Active ingredient RANIBIZUMAB-NUNA Form and strength INJECTABLE;INJECTION - 0.5MG(10MG/ML) Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2026-03-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview BYOOVIZ is listed in Drugs@FDA under application 761202 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient RANIBIZUMAB-NUNA Form and strength INJECTABLE;INJECTION - 0.5MG(10MG/ML) Sponsor SAMSUNG BIOEPIS CO LTD Submission history Latest submission status date: 2026-03-30 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.