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:
2018-03-22
Original market date: See footnote 1
2018-03-22
Product name:
RENFLEXIS
Description:
SINGLE USE VIAL
DIN:
02470373
Product Monograph/Veterinary Labelling:
Date:
2023-10-04
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SAMSUNG BIOEPIS CO., LTD
76, Songdogyoyuk-Ro, Yeonsu-Gu
Incheon
Incheon
Korea, Republic Of
21987
Class:
Human
Dosage form(s):
Powder For 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
92:36.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AB02 INFLIXIMAB
Active ingredient group (AIG) number:See footnote5
0144162001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| INFLIXIMAB | 100 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Registry |