Vaccine Information: EVUSHELD (Page 8 of 8)

Package/Label Display Panel

tixagevimab

Injection

150 mg/1.5 mL

(100mg/mL)

For Intramuscular Use.

1.5 mL single-dose vial.

MUST ADMINISTER

WITH CILGAVIMAB

Rx only

NDC 0310-8895-01

Discard unused portion.

No preservative. Store at

2° to 8°C (36° to 46°F).

Do not freeze or shake.

Protect from light.

For use under Emergency

Use Authorization (EUA)

AstraZeneca

Package/Label Display Panel

cilgavimab

Injection

150 mg/1.5 mL

(100mg/mL)

For Intramuscular Use.

1.5 mL single-dose vial.

MUST ADMINISTER

WITH TIXAGEVIMAB

Rx only

NDC 0310-1061-01

Discard unused portion.

No preservative. Store at

2° to 8°C (36° to 46°F).

Do not freeze or shake.

Protect from light.

For use under Emergency

Use Authorization (EUA)

AstraZeneca

Package/Label Display Panel

NDC 0310-7442-02

EVUSHELD™

(tixagevimab) Injection

150 mg/1.5 mL

(100mg/mL)

Co-packaged with

(cilgavimab) injection

150 mg/1.5 mL

(100mg/mL)

For use under Emergency Use Authorization (EUA)

For Intramuscular Use

Keep vials in original carton to protect from light.

Discard unused portion.

Each carton contains two (2) vials:

One 1.5 mL single-dose vial of tixagevimab

One 1.5 mL single-dose vial of cilgavimab

ATTENTION HEALTHCARE PROVIDER: EACH

VIAL MUST BE ADMINISTERED SEPARATELY

BY INTRAMUSCULAR INJECTION

Refer to FDA-Authorized Fact Sheets

for Dosage and Administration.

Rx only AstraZeneca

EVUSHELD azd7442 kit

Product Information Product Type VACCINE Item Code (Source) NDC:0310-7442

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0310-7442-02 1 KIT in 1 PACKAGE None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL 1.0 mL Part 2 1 VIAL 1.0 mL

Part 1 of 2 AZD1061 azd1061 injection, solution

Product Information Item Code (Source) NDC:0310-1061 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CILGAVIMAB (CILGAVIMAB) CILGAVIMAB 150 mg in 1.5 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE 2.4 mg in 1.5 mL HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE 3.0 mg in 1.5 mL SUCROSE 123.2 mg in 1.5 mL POLYSORBATE 80 0.6 mg in 1.5 mL WATER 1312 mg in 1.5 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0310-1061-01 1.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Emergency Use Authorization 12/08/2021

Part 2 of 2 AZD8895 azd8895 injection, solution

Product Information Item Code (Source) NDC:0310-8895 Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TIXAGEVIMAB (TIXAGEVIMAB) TIXAGEVIMAB 150 mg in 1.5 mL

Inactive Ingredients Ingredient Name Strength HISTIDINE 2.4 mg in 1.5 mL HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE 3.0 mg in 1.5 mL SUCROSE 123.2 mg in 1.5 mL POLYSORBATE 80 0.6 mg in 1.5 mL WATER 1312 mg in 1.5 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0310-8895-01 1.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Emergency Use Authorization 12/08/2021

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Emergency Use Authorization 12/08/2021

Labeler — AstraZeneca Pharmaceuticals LP (054743190)

Registrant — AstraZeneca PLC (230790719)

Revised: 12/2022 AstraZeneca Pharmaceuticals LP