Byooviz (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Each BYOOVIZ 0.5 mg carton (NDC 64406-019-01) contains a single-dose, 2-mL glass vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab-nuna solution that is clear to slightly opalescent and colorless to pale yellow.

EACH CARTON IS FOR SINGLE-EYE USE ONLY.

BYOOVIZ should be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE. Do not use beyond the date stamped on the label. Protect BYOOVIZ vials from light and store in the original carton until time of use.

17 PATIENT COUNSELING INFORMATION

Advise patients that in the days following BYOOVIZ administration, patients are at risk of developing endophthalmitis. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions (5.1) ].

BYOOVIZ (ranibizumab-nuna)

Manufactured by:
Samsung Bioepis Co., Ltd.
76, Songdogyoyuk-ro,
Yeonsu-gu, Incheon, 21987
Republic of Korea
US License No. 2046

Manufactured for:
Biogen Inc.
225 Binney Street, Cambridge
MA, 02142United States

BYOOVIZ is a trademark of Biogen Inc.

PRINCIPAL DISPLAY PANEL — 0.5 mg Vial Carton

NDC 64406-019-01

Rx only

Byooviz™ 0.5mg wAMD RVO mCNO

(ranibizumab-nuna)

Injection

0.5 mg single-dose vial.

Discard unused portion.

IMPORTANT:

A 5-micron sterile filter needle (19-gauge x 1-1/2 inch) is required for preparation, but not included.

See enclosed package insert.

For intravitreal injection.

INDICATED FOR:

Neovascular (wet) age-related macular degeneration (AMD)

Macular edema following retinal vein occlusion (RVO)

Myopic choroidal neovascularization (mCNV)

KEEP REFRIGERATED.

DO NOT FREEZE.

PROTECT VIAL FROM LIGHT.

SAMSUNG BIOEPIS, Biogen_®

BYOOVIZ ranibizumab-nuna injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64406-019 Route of Administration INTRAVITREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ranibizumab (ranibizumab) ranibizumab 10 mg in 1 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE MONOHYDROCHLORIDE HISTIDINE TREHALOSE DIHYDRATE POLYSORBATE 20 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64406-019-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64406-019-07) 1 NDC:64406-019-07 0.05 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64406-019-01) 2 NDC:64406-019-08 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (64406-019-09) 2 NDC:64406-019-09 0.05 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (64406-019-08)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761202 06/01/2022

Labeler — BIOGEN INC. (121376230)

Registrant — Samsung Bioepis Co., Ltd. (557822226)

Revised: 09/2022 BIOGEN INC.