VAXZEVRIA SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

CHADOX1-S [RECOMBINANT]

から入手可能:

ASTRAZENECA CANADA INC

ATCコード:

J07BN02

INN（国際名）:

COVID-19, VIRAL VECTOR, NON-REPLICATING

投薬量:

50000000000VP

医薬品形態:

SOLUTION

構図:

CHADOX1-S [RECOMBINANT] 50000000000VP

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

100

処方タイプ:

Schedule D

製品概要:

Active ingredient group (AIG) number: 0162722001; AHFS:

認証ステータス:

AUTHORIZATION BY INTERIM ORDER REVOKED

承認日:

2021-11-19

製品の特徴

_ _
_VAXZEVRIA™ Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
VAXZEVRIA™
COVID-19 VACCINE (CHADOX1-S [RECOMBINANT]),
SOLUTION FOR INTRAMUSCULAR INJECTION
Multiple Dose Vial
(10 dose vial presentation, 5 x 10
10
viral particles per dose)
Active Immunizing Agent
ATC Code: J07BX03
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
November 19, 2021
Date of Revision:
December 14, 2022
Submission Control Number: 267545
VAXZEVRIA™ is a trademark of AstraZeneca UK Ltd., used under license
by AstraZeneca
Canada Inc.
© AstraZeneca Canada Inc. 2022
_ _
_VAXZEVRIA™ Product Monograph_
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
04/2021
2 CONTRAINDICATIONS
06/2021
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
04/2021
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
03/2021
7 WARNINGS AND PRECAUTIONS, General
03/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
03/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
03/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
04/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
06/2021
7 WARNINGS AND PRECAUTIONS, Neurologic
07/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
11/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES ..............................................................................
2
TABLE OF CONTENTS ....................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ..................................................... 4
1
INDICATIONS .........................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
............................................................................................