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:
Marketed
Current status date:
2023-07-05
Original market date: See footnote 1
2023-07-05
Product name:
COLUMVI
Description:
SINGLE-USE VIAL 1MG/ML
DIN:
02536552
Product Monograph/Veterinary Labelling:
Date:
2023-03-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
HOFFMANN-LA ROCHE LIMITED
7070 Mississauga Road
Mississauga
Ontario
Canada
L5N 5M8
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01FX28 GLOFITAMAB
Active ingredient group (AIG) number:See footnote5
0164522001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| GLOFITAMAB | 2.5 MG / 2.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Clinical Trials |