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:
2013-05-09
Original market date: See footnote 1
2013-05-09
Product name:
ORENCIA
Description:
PRE-FILLED SYRINGE
DIN:
02402475
Product Monograph/Veterinary Labelling:
Date:
2023-05-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BRISTOL-MYERS SQUIBB CANADA
2344 Boul. Alfred-Nobel, Suite 300
St-Laurent
Quebec
Canada
H4S 0A4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
90:24.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AA24 ABATACEPT
Active ingredient group (AIG) number:See footnote5
0151647002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ABATACEPT | 125 MG / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Registry |