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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:

2017-08-04

Original market date: See footnote 1

2017-08-04

Product name:

CIMZIA

Description:

SINGLE-USE AUTOINJECTOR

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:

02465574

Product Monograph/Veterinary Labelling:

Date: 2019-11-13 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

UCB CANADA INC
602  2201 Bristol Circle
Oakville
Ontario
Canada  L6H 0J8

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:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:92.00   MISCELLANEOUS GI DRUGS ,  92:36.00   DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AB05  CERTOLIZUMAB PEGOL

Active ingredient group (AIG) number:See footnote 5

0152646001

List of active ingredient(s)
Active ingredient(s) Strength
CERTOLIZUMAB PEGOL 200 MG / ML

Application information

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