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:
2021-05-26
Product name:
ABECMA
DIN:
02516233
Product Monograph/Veterinary Labelling:
Date:
2021-07-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
CELGENE INC
300
2344 Alfred-Nobel Boulevard
Saint-Laurent
Quebec
Canada
H4S 0A4
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
L01XL07 IDECABTAGENE VICLEUCEL
Active ingredient group (AIG) number:See footnote5
0162927001
| Active ingredient(s) | Strength |
|---|---|
| IDECABTAGENE VICLEUCEL | 520000000 CELLS |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Wallet Card |
| Healthcare Professional Education |
| Patient Education |