PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- original and omicron ba.4/ba.5 injection, suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ), BNT162B2 OMICRON (BA.4/BA.5) (UNII: JSV288Q5CV) (BNT162B2 OMICRON (BA.4/BA.5) - UNII:JSV288Q5CV)

から入手可能:

Pfizer Manufacturing Belgium NV

投与経路:

INTRAMUSCULAR

製品の特徴

PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- ORIGINAL AND OMICRON
BA.4/BA.5 INJECTION, SUSPENSION
PFIZER MANUFACTURING BELGIUM NV
----------
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
ORIGINAL AND OMICRON BA.4/BA.5
PRINCIPAL DISPLAY PANEL
Image not
available
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
original and omicron ba.4/ba.5 injection, suspension
PRODUCT INFORMATION
PRODUCT TYPE
VACCINE
ITEM CODE (SOURCE)
NDC:59267-0609
ROUTE OF ADMINISTRATION
INTRAMUSCULAR
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ)
TOZ INAMERAN
0.02 mg
in 2.6 mL
BNT162B2 OMICRON (BA.4/BA.5) (UNII: JSV288Q5CV) (BNT162B2 OMICRON
(BA.4/BA.5) - UNII:JSV288Q5CV)
BNT162B2 OMICRON
(BA.4/BA.5)
0.02 mg
in 2.6 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H)
0.07 mg
in 2.6 mL
((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE)
(UNII:
AVX8DX713V)
0.57 mg
in 2.6 mL
TROMETHAMINE (UNII: 023C2WHX2V)
0.08 mg
in 2.6 mL
TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)
0.53 mg
in 2.6 mL
SUCROSE (UNII: C151H8M554)
41.2 mg
in 2.6 mL
1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)
0.12 mg
in 2.6 mL
CHOLESTEROL (UNII: 97C5T2UQ7J)
0.25 mg
in 2.6 mL
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
19.8 mg
in 2.6 mL
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:59267-
0609-2
10 in 1 CARTON
1
NDC:59267-
0609-1
2.6 mL in 1 VIAL, GLASS; Type 0: Not a
Combination Product
MARKETING INFORMATION
MARKETING CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
EMERGENCY USE
AUTHORIZ ATION
08/15/2022
LABELER -
Pfizer Manufacturing Belgium NV (370156507)
REGISTRANT -
Pfizer Inc (113480771)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Pfizer Manufacturing
Belgium NV
370156507
ANALYSIS(59267-0609) , MANUFACTURE(59267-0609) , PACK(59267-
0609) , LABEL(59267-0609)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS