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:
2023-02-09
Product name:
CARVYKTI
Description:
SINGLE USE BAG
DIN:
02535270
Product Monograph/Veterinary Labelling:
Date:
2023-02-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada
M3C 1L9
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
26:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01XL05 CILTACABTAGENE AUTOLEUCEL
Active ingredient group (AIG) number:See footnote5
0164442001
| Active ingredient(s) | Strength |
|---|---|
| CILTACABTAGENE 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 Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |