AS03 injection, solution

AS03 by

Drug Labeling and Warnings

AS03 by is a Other medication manufactured, distributed, or labeled by GlaxoSmithKline Biologicals SA. 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

NDC: 58160-855-19

AS03 Adjuvant Component

NOTICE: NOT TO BE USED ALONE

One vial of AS03 Adjuvant Component and one vial of Antigen Component MUST BE COMBINED BEFORE USE.

10 Vials of AS03 Adjuvant Component

One vial of AS03 Adjuvant Component must be added to one vial of Antigen Component to form ten 0.5-mL doses of vaccine.

Rx only

Rev. 11/20

504407

INGREDIENTS AND APPEARANCE

AS03 
as03 injection, solution

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 58160-855
Route of Administration	INTRAMUSCULAR

Ingredients
Ingredient Kind	Ingredient Name	Quantity
ADJV	SQUALENE (UNII: 7QWM220FJH)
ADJV	.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ADJV	POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58160-855-19	10 in 1 CARTON
1	NDC: 58160-855-01	2.5 mL in 1 VIAL; 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 - GlaxoSmithKline Biologicals SA (372748392)