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:
Approved
Current status date:
2024-03-06
Product name:
BREYANZI
Description:
SINGLE DOSE VIALS - CD8 AND CD4 COMPONENTS
DIN:
02527138
Product Monograph/Veterinary Labelling:
Date:
2024-03-06
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BRISTOL-MYERS SQUIBB CANADA
2344 Boul. Alfred-Nobel, Suite 300
St-Laurent
Quebec
Canada
H4S 0A4
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
L01XL08 LISOCABTAGENE MARALEUCEL
Active ingredient group (AIG) number:See footnote5
0163641001
| Active ingredient(s) | Strength |
|---|---|
| LISOCABTAGENE MARALEUCEL | 120000000 CELLS |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |
| Patient Education |
| Patient Wallet Card |
| Healthcare Professional Education |
| Healthcare Professional Checklist |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |