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:
2024-07-30
Original market date: See footnote 1
2015-03-03
Product name:
SYLVANT
Description:
SINGLE USE VIAL
DIN:
02435136
Product Monograph/Veterinary Labelling:
Date:
2024-07-30
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
RECORDATI RARE DISEASES CANADA INC
3080 Yonge Street, Suite 6060
Toronto
Ontario
Canada
M4N 3N1
Class:
Human
Dosage form(s):
Powder For 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
90:28.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AC11 SILTUXIMAB
Active ingredient group (AIG) number:See footnote5
0156310002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| SILTUXIMAB | 400 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.