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:
2024-09-23
Product name:
CASGEVY
DIN:
02552043
Product Monograph/Veterinary Labelling:
Date:
2024-09-23
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
1520
20 Bay Street
Toronto
Ontario
Canada
M5J 2N8
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
B06AX05 EXAGAMGLOGENE AUTOTEMCEL
Active ingredient group (AIG) number:See footnote5
0166245001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| EXAGAMGLOGENE AUTOTEMCEL | 13000000 CELLS / ML |