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:

2020-07-08

Original market date: See footnote 1

2020-07-08

Product name:

ENTYVIO

Description:

SINGLE USE PRE-FILLED PEN

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:

02497867

Product Monograph/Veterinary Labelling:

Date: 2023-11-17 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

TAKEDA CANADA INC
3800 22 Adelaide Street West
Toronto
Ontario
Canada M5H 4E3

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Schedule D ,  Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

56:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AG05 VEDOLIZUMAB

Active ingredient group (AIG) number:See footnote5

0156530002

List of active ingredient(s)
Active ingredient(s) Strength
VEDOLIZUMAB 108 MG / 0.68 ML

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Patient Wallet Card
Pharmacovigilance/Monitoring Activity
Clinical Trials
Registry
Version 4.0.2
Date modified: