Product information

From Health Canada

New search

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:

2016-09-23

Original market date: See footnote 1

2016-09-23

Product name:

BRENZYS

Description:

PRE-FILLED SYRINGE

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:

02455323

Product Monograph/Veterinary Labelling:

Date: 2020-08-19 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SAMSUNG BIOEPIS CO., LTD
76, Songdogyoyuk-Ro, Yeonsu-Gu
Incheon
Incheon
Korea, Republic Of  21987

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Schedule D,  Prescription  

Biosimilar Biologic Drug:

Yes

American Hospital Formulary Service (AHFS): See footnote 3

92:36.00   DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AB01  ETANERCEPT

Active ingredient group (AIG) number:See footnote 5

0151564001

List of active ingredient(s)
Active ingredient(s) Strength
ETANERCEPT 50 MG / ML

Application information

Related information

Contact us

Version 3.8.0
Date modified: