ADAKVEO (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 0078-0883-61

Rx Only

ADAKVEO®

(crizanlizumab-tmca)
Injection

100 mg/10 mL
(10 mg/mL)

For intravenous infusion after dilution.

1 Single-Dose Vial.Discard Unused Portion.

NOVARTIS

PRINCIPAL DISPLAY PANEL
							NDC 0078-0883-61 
							Rx Only
							ADAKVEO®
							(crizanlizumab-tmca)
							Injection
							100 mg/10 mL
							(10 mg/mL)
							For intravenous infusion after dilution.
							1 Single-Dose Vial.
							Discard Unused Portion.
							NOVARTIS
(click image for full-size original)

ADAKVEO crizanlizumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0883
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CRIZANLIZUMAB (CRIZANLIZUMAB) CRIZANLIZUMAB 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE 75.33 mg in 1 mL
SODIUM CITRATE 5.053 mg in 1 mL
CITRIC ACID MONOHYDRATE 0.54 mg in 1 mL
POLYSORBATE 80 0.200 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0883-61 10 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761128 11/15/2019
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 06/2020 Novartis Pharmaceuticals Corporation

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.