ANTIGEN COMPONENT- cov-2 pres dtm antigen injection, emulsion

ANTIGEN COMPONENT by

Drug Labeling and Warnings

ANTIGEN COMPONENT by is a Other medication manufactured, distributed, or labeled by Sanofi Pasteur Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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 of
Antigen Component to form the Vaccine.

794426

SANOFI PASTEUR

INGREDIENTS AND APPEARANCE

ANTIGEN COMPONENT 
cov-2 pres dtm antigen injection, emulsion

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 49281-618
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COV-2 PRES DTM ANTIGEN (UNII: 76SQ8FDG7I) (COV-2 PRES DTM ANTIGEN - UNII:76SQ8FDG7I)	COV-2 PRES DTM ANTIGEN	50 ug  in 2.5 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	22 mg  in 2.5 mL
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)	6.5 mg  in 2.5 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)	0.975 mg  in 2.5 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	13.75 mg  in 2.5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49281-618-20	10 in 1 CARTON
1	NDC: 49281-618-78	2.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

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	Business Operations
Sanofi Pasteur Inc.		086723285	MANUFACTURE(49281-618)