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:
2024-06-03
Original market date: See footnote 1
2024-06-03
Product name:
ADTRALZA
Description:
PRE-FILLED PENS
DIN:
02540193
Product Monograph/Veterinary Labelling:
Date:
2023-08-04
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LEO PHARMA INC
6 Adelaide Street East, Suite 200
Toronto
Ontario
Canada
M5C 1H6
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
84:06.28
Anatomical Therapeutic Chemical (ATC): See footnote 4
D11AH07 TRALOKINUMAB
Active ingredient group (AIG) number:See footnote5
0163195001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TRALOKINUMAB | 300 MG / 2 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |