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
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
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 |