Vaccine Information: AS03

AS03- injection, solution
GlaxoSmithKline Biologicals SA

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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

AS03 Adjuvant 10 count carton
(click image for full-size original)
AS03
as03 injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-855
Route of Administration INTRAMUSCULAR DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-855-19 10 VIAL in 1 CARTON contains a VIAL (58160-855-01)
1 NDC:58160-855-01 2.5 mL in 1 VIAL This package is contained within the CARTON (58160-855-19)
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)

Revised: 06/2022 GlaxoSmithKline Biologicals SA

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