Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2022-07-18

Original market date: See footnote 1

2022-07-18

Product name:

VABYSMO

Description:

SINGLE USE VIAL

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02527618

Product Monograph/Veterinary Labelling:

Date: 2023-09-13 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

HOFFMANN-LA ROCHE LIMITED
7070 Mississauga Road
Mississauga
Ontario
Canada L5N 5M8

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravitreal

Number of active ingredient(s):

1

Schedule(s):

Schedule D ,  Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

52:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

S01LA09 FARICIMAB

Active ingredient group (AIG) number:See footnote5

0163722001

List of active ingredient(s)
Active ingredient(s) Strength
FARICIMAB 6 MG / 0.05 ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

Additional Risk Minimization Measures
Patient Education
Pharmacovigilance/Monitoring Activity
Observational Studies
Version 4.0.2
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