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:

2022-03-17

Original market date: See footnote 1

2022-03-17

Product name:

ADTRALZA

Description:

PREFILLED SYRINGES

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:

02521288

Product Monograph/Veterinary Labelling:

Date: 2023-08-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

LEO PHARMA INC
3389 Steeles Avenue East, Suite 110
Toronto
Ontario
Canada M2H 3S8

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

84:92.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

D11AH07 TRALOKINUMAB

Active ingredient group (AIG) number:See footnote5

0163195001

List of active ingredient(s)
Active ingredient(s) Strength
TRALOKINUMAB 150 MG / ML

Risk Management Plans See footnote 7

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

Pharmacovigilance/Monitoring Activity
Observational Studies
Clinical Trials
Version 4.0.2
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