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:
2023-12-15
Original market date: See footnote 1
2023-12-15
Product name:
TECARTUS
DIN:
02532719
Product Monograph/Veterinary Labelling:
Date:
2024-06-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GILEAD SCIENCES CANADA INC
400
6925 Century Avenue
Mississauga
Ontario
Canada
L5N 7K2
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intravenous
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
L01XL06 BREXUCABTAGENE AUTOLEUCEL
Active ingredient group (AIG) number:See footnote5
0162968002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BREXUCABTAGENE AUTOLEUCEL | 100000000 CELLS / BAG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |
| Healthcare Professional Education |
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Registry |
| Observational Studies |