VABYSMO SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

FARICIMAB

Fáanlegur frá:

HOFFMANN-LA ROCHE LIMITED

ATC númer:

S01LA09

INN (Alþjóðlegt nafn):

FARICIMAB

Skammtar:

6MG

Lyfjaform:

SOLUTION

Samsetning:

FARICIMAB 6MG

Stjórnsýsluleið:

INTRAVITREAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Vörulýsing:

Active ingredient group (AIG) number: 0163722001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-05-27

Vara einkenni

_Pr_
_VABYSMO_
_®_
_ (faricimab) _
_Page 0 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VABYSMO®
faricimab injection
Single-use vials
6 mg/0.05 mL solution for intravitreal injection
Professed Standard
Ophthalmological / Anti-vascular endothelial growth factor and
anti-angiopoietin-2 agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
www.rochecanada.com
Date of Initial Authorization:
MAY 27, 2022
Date of Revision:
SEP 13, 2023
Submission Control Number: 268321
VABYSMO® is a registered trade-mark of F. Hoffmann-La Roche AG, used
under license
©
Copyright 2023, Hoffmann-La Roche Limited
_ _
_Pr_
_VABYSMO_
_®_
_ (faricimab) _
_Page 1 of 35_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
08/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
1
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
1
INDICATIONS
.............................................................................................................
3
1.1
PEDIATRICS
.................................................................................................................
3
1.2
GERIATRICS..................................................................................................................
3
2
CONTRAINDICATIONS
................................................................................................
3
4
DOSAGE AND ADMINISTRATION
................................................................................
3
4.1
DOSING
CONSIDERATIONS.............................................................................................
3
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 4
4.3
RECO