AS03 injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Dostupno od:

GlaxoSmithKline Biologicals SA

Administracija rute:

INTRAMUSCULAR

Status autorizacije:

unapproved drug other

Svojstava lijeka

AS03- AS03 INJECTION, SOLUTION
GLAXOSMITHKLINE BIOLOGICALS SA
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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
AS03
as03 injection, solution
GlaxoSmithKline Biologicals SA
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)
Revised: 1/2024