Vaccine Information: ANTIGEN COMPONENT

ANTIGEN COMPONENT- cov-2 pres dtm antigen injection, emulsion
Sanofi Pasteur Inc.

Health Care Professional and Patient Fact Sheets are not available at this time.

PRINCIPAL DISPLAY PANEL — 10 Dose Vial Label

NDC 49281-618-78
Vial 1 of 2
ANTIGEN COMPONENT
for Sanofi Pasteur COVID-19 Vaccine, Adjuvanted

After mixing, emulsion for intramuscular injection
For use under Emergency Use Authorization.
NOT TO BE USED ALONE.
Add 1 vial of AS03 Adjuvant Component to form the Vaccine.
Multiple Dose Vial (after mixing, contains 10 doses of 0.5 mL). After
mixing, hold at 23°C to 27°C (73°F to 80°F). Discard after 6 hours.
Refer to FDA-authorized Fact Sheet for mixing instructions.
No Preservative
Record date and time of mixing:Manufactured by: Sanofi Pasteur Inc.

PRINCIPAL DISPLAY PANEL -- 10 Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Vial Carton

NDC 49281-618-20
ANTIGEN COMPONENT
for Sanofi Pasteur COVID-19 Vaccine, Adjuvanted

After mixing, emulsion for intramuscular injection
For use under Emergency Use Authorization

CONTENTS: 10 Multiple Dose Vials (after mixing with AS03 Adjuvant Component,
each vial contains ten 0.5 mL doses of Vaccine)

NOTICE: NOT TO BE USED ALONE
One vial of AS03 Adjuvant Component MUST BE ADDED to one vial ofAntigen Component to form the Vaccine.

794426

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 10 Vial Carton
(click image for full-size original)
ANTIGEN COMPONENT cov-2 pres dtm antigen injection, emulsion
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-618
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COV-2 PRES DTM ANTIGEN (COV-2 PRES DTM ANTIGEN) COV-2 PRES DTM ANTIGEN 50 ug in 2.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 22 mg in 2.5 mL
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE 6.5 mg in 2.5 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 0.975 mg in 2.5 mL
POLYSORBATE 20 13.75 mg in 2.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-618-20 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (49281-618-78)
1 NDC:49281-618-78 2.5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (49281-618-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/10/2020
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Inc. 086723285 MANUFACTURE (49281-618)

Revised: 11/2020 Sanofi Pasteur Inc.

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