NUVAXOVID XBB.1.5 SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SARS-COV-2 RECOMBINANT SPIKE PROTEIN (OMICRON XBB.1.5)

から入手可能:

NOVAVAX INC.

ATCコード:

J07BN04

INN（国際名）:

COVID-19, PROTEIN SUBUNIT

投薬量:

5MCG

医薬品形態:

SUSPENSION

構図:

SARS-COV-2 RECOMBINANT SPIKE PROTEIN (OMICRON XBB.1.5) 5MCG

投与経路:

INTRAMUSCULAR

パッケージ内のユニット:

15G/50G

処方タイプ:

Schedule D

製品概要:

Active ingredient group (AIG) number: 0165423001; AHFS:

認証ステータス:

APPROVED

承認日:

2023-12-05

製品の特徴

_ _
_Product Monograph _
_ _
NUVAXOVID ™
_ _
XBB.1.5
_, COVID-19 Vaccine (Recombinant protein, Adjuvanted) _
_Page 1 of 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
NUVAXOVID ™ XBB.1.5
COVID-19 Vaccine (Recombinant protein, Adjuvanted)
Suspension for intramuscular injection
Multidose Vial, 5 mcg / 0.5 mL (per dose)
(contains 5 doses of 0.5 mL)
Active Immunizing Agent
ATC Classification: J07BN04
NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein,
Adjuvanted) vaccine is indicated for:
•
Active immunization against coronavirus disease 2019 (COVID-19) caused
by the severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) virus in individuals 12 years of age and
older.
NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine (Recombinant protein,
Adjuvanted) vaccine has been issued marketing authorization with
Terms and Conditions that need to be met by the Market Authorization
Holder to ascertain the continued quality, safety and
effectiveness of the vaccine.
Patients should be advised of the nature of the authorization. For
further information for NUVAXOVID ™ XBB.1.5 COVID-19 Vaccine
(Recombinant protein, Adjuvanted) vaccine please refer to Health
Canada’s COVID-19 vaccines and transfer portal. COVID-19
vaccines and treatments portal (canada.ca)
Novavax, Inc.
21 Firstfield Road
Gaithersburg, MD, 20878
IMPORTED BY:
Innomar Strategies Inc.
3470 Superior Ct
Oakville, ON, L6L 0C4
Date of Initial Authorization:
December 5, 2023
Submission Control Number: 278519
_ _
_Product Monograph _
_ _
NUVAXOVID ™
_ _
XBB.1.5
_, COVID-19 Vaccine (Recombinant protein, Adjuvanted) _
_Page 2 of 51 _
RECENT MAJOR LABEL CHANGES
_ _
_Product Monograph _
_ _
NUVAXOVID ™
_ _
XBB.1.5
_, COVID-19 Vaccine (Recombinant protein, Adjuvanted) _
_Page 3 of 51 _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
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