Susvimo (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 50242-078-55

Susvimo™
(ranibizumab injection)

See instructions for use
included with the
Susvimo ocular implantwith insertion tool assembly

100 mg/mL

Vial contains 10 mg/0.1 mL ranibizumab

For use with Susvimo ocular implant

Dispense the enclosed Medication Guide to each patient.

Carton contents:

• One Susvimo single-dose vial
• One Susvimo initial fill needle

Rx only

Genentech

10233586

PRINCIPAL DISPLAY PANEL — 10 mg/0.1 mL Vial Carton

NDC 50242-078-12

Susvimo™
(ranibizumab injection)

100 mg/mL

Vial contains
10 mg/0.1 mL ranibizumab

For use with Susvimo
ocular implant

Dispense the enclosedMedication Guide to each patient.

Rx only

1 Single-dose vial

Genentech

10233583

SUSVIMO ranibizumab injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50242-078 Route of Administration INTRAVITREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANIBIZUMAB (RANIBIZUMAB) RANIBIZUMAB 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE SUCROSE POLYSORBATE 20 WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50242-078-12 1 VIAL in 1 CARTON contains a VIAL 1 1 mL in 1 VIAL This package is contained within the CARTON (50242-078-12) 2 NDC:50242-078-55 1 VIAL in 1 CARTON contains a VIAL 2 1 mL in 1 VIAL This package is contained within the CARTON (50242-078-55)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA761197 10/22/2021

Labeler — Genentech, Inc. (080129000)

Registrant — Genentech, Inc. (080129000)

Establishment
Name	Address	ID/FEI	Operations
Roche Singapore Technical Operations Pte. Ltd.		937189173	ANALYSIS (50242-078), API MANUFACTURE (50242-078)

Establishment
Name	Address	ID/FEI	Operations
Genentech, Inc.		080129000	ANALYSIS (50242-078)

Establishment
Name	Address	ID/FEI	Operations
Genentech, Inc.		004074162	ANALYSIS (50242-078)

Establishment
Name	Address	ID/FEI	Operations
Genentech, Inc.		833220176	PACK (50242-078), LABEL (50242-078), ANALYSIS (50242-078)

Revised: 11/2022 Genentech, Inc.