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:

2012-11-24

Original market date: See footnote 1

2004-09-24

Product name:

HUMIRA

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:

02258595

Product Monograph/Veterinary Labelling:

Date: 2022-09-16 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

ABBVIE CORPORATION
8401 Trans-Canada Highway
Saint-Laurent
Quebec
Canada H4S 1Z1

Class:

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription ,  Schedule D

 

American Hospital Formulary Service (AHFS): See footnote 3

92:36.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AB04 ADALIMUMAB

Active ingredient group (AIG) number:See footnote5

0150364001

List of active ingredient(s)
Active ingredient(s) Strength
ADALIMUMAB 40 MG / 0.8 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
Observational Studies
Registry
Version 4.0.2
Date modified: