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:
2023-10-20
Original market date: See footnote 1
2023-10-20
Product name:
TECVAYLI
Description:
SINGLE-USE VIAL
DIN:
02539764
Product Monograph/Veterinary Labelling:
Date:
2024-08-29
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada
M3C 1L9
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01FX24 TECLISTAMAB
Active ingredient group (AIG) number:See footnote5
0164822002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TECLISTAMAB | 153 MG / 1.7 ML |