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:
2024-08-22
Original market date: See footnote 1
2019-12-11
Product name:
TRUXIMA
Description:
SINGLE-DOSE VIAL - 10 MG/ML
DIN:
02478390
Product Monograph/Veterinary Labelling:
Date:
2024-08-22
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
CELLTRION INC.
23 Academy-Ro, Yeonsu-Gu
Incheon
--
Korea, Republic Of
22014
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
Biosimilar Biologic Drug:
Yes
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01FA01 RITUXIMAB
Active ingredient group (AIG) number:See footnote5
0140241001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| RITUXIMAB | 500 MG / 50 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 Education |
| Patient Wallet Card |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |