BAVENCIO (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Carton

NDC 44087-3535-1

BAVENCIO ®
(avelumab)
Injection

200 mg/10 mL
(20 mg/mL)

For intravenous infusion
after dilution
Single-dose vial
Discard unused portion.

Dispense the enclosed
Medication Guide to each
patient.

1 vial
Rx only

EMD SERONO

Pfizer

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Carton
(click image for full-size original)
BAVENCIO avelumab injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44087-3535
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
avelumab (avelumab) avelumab 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL
acetic acid
polysorbate 20
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44087-3535-1 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (44087-3535-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761049 03/23/2017
Labeler — EMD Serono, Inc. (088514898)

Revised: 11/2020 EMD Serono, Inc.

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