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:
2022-03-30
Original market date: See footnote 1
2022-03-30
Product name:
BIMZELX
Description:
AUTOINJECTOR
DIN:
02525275
Product Monograph/Veterinary Labelling:
Date:
2024-11-27
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
UCB CANADA INC
602
2201 Bristol Circle
Oakville
Ontario
Canada
L6H 0J8
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
84:06.28
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AC21 BIMEKIZUMAB
Active ingredient group (AIG) number:See footnote5
0163399001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BIMEKIZUMAB | 160 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |
| Registry |