Vaccine Information: AS03

AS03- injection, solution
GlaxoSmithKline Biologicals SA

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NDC 58160-855-19

AS03 Adjuvant Component


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


AS03 Adjuvant 10 count carton
(click image for full-size original)
as03 injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-855
Route of Administration INTRAMUSCULAR DEA Schedule
# 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 provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

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