SUSVIMO SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

RANIBIZUMAB

Available from:

HOFFMANN-LA ROCHE LIMITED

ATC code:

S01LA04

INN (International Name):

RANIBIZUMAB

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

RANIBIZUMAB 100MG

Administration route:

INTRAVITREAL

Units in package:

100

Prescription type:

Schedule D

Product summary:

Active ingredient group (AIG) number: 0152224002; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-09-14

Summary of Product characteristics

_ _
_Pr_
_SUSVIMO_
_TM_
_ (ranibizumab injection) _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SUSVIMO™
ranibizumab injection
Single-use vials
100 mg/mL sterile solution for intravitreal use via SUSVIMO ocular
implant
Ophthalmological / Anti-Vascular Endothelial Growth Factor-A agent
ATC Code: S01LA04
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
Date of Initial Authorization:
SEPT 14, 2022
Submission Control Number: 254848
SUSVIMO™ is a trade-mark of F.Hoffmann-La Roche AG, used under
license.
©
Copyright 2022, Hoffmann-La Roche Limited
_ _
_Pr_
_SUSVIMO_
_TM_
_ (ranibizumab injection) _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
N/A
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
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 4
4.
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Do