AREXVY POWDER FOR SUSPENSION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

RESPIRATORY SYNCYTIAL VIRUS PREFUSION F PROTEIN (RSVPREF3)

Saatavilla:

GLAXOSMITHKLINE INC

ATC-koodi:

J07

INN (Kansainvälinen yleisnimi):

VACCINES

Annos:

120MCG

Lääkemuoto:

POWDER FOR SUSPENSION

Koostumus:

RESPIRATORY SYNCYTIAL VIRUS PREFUSION F PROTEIN (RSVPREF3) 120MCG

Antoreitti:

INTRAMUSCULAR

Kpl paketissa:

15G/50G

Prescription tyyppi:

Schedule D

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0164921001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-08-04

Valmisteyhteenveto

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_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AREXVY
Respiratory Syncytial Virus (RSV) Vaccine (recombinant, AS01
E
adjuvanted)
120 micrograms Respiratory Syncytial Virus glycoprotein F (RSVPreF3)
Lyophilized Powder and Suspension for Reconstitution
Reconstituted Suspension for Intramuscular Injection
Active Immunizing Agent
GlaxoSmithKline Inc.
100 Milverton Drive
Mississauga, Ontario
L5R 4H1
Date of Initial Approval:
August 4, 2023
Submission Control Number: 269021
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_Page 2 of 22_
RECENT MAJOR LABEL CHANGES
New Vaccine Product Monograph
08/2023
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
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.3
Reconstitution
....................................................