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:
2025-08-15
Product name:
AMTAGVI
DIN:
02560232
Product Monograph/Veterinary Labelling:
Date:
2025-08-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
IOVANCE BIOTHERAPEUTICS, INC.
825 Industrial Road
San Carlos
California
United States
94070
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
L01XL11 LIFILEUCEL
Active ingredient group (AIG) number:See footnote5
0167739001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| LIFILEUCEL | 72000000000 CELLS / 100 ML |
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 Consent |
| Patient Education |
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Clinical Trials |