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:
2019-07-08
Original market date: See footnote 1
2019-07-08
Product name:
ONSTRYV
DIN:
02484641
Product Monograph/Veterinary Labelling:
Date:
2020-12-16
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VALEO PHARMA INC
16667 Hymus Blvd.
Kirkland
Quebec
Canada
H9H 4R9
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
28:36.32
Anatomical Therapeutic Chemical (ATC): See footnote 4
N04BD03 SAFINAMIDE
Active ingredient group (AIG) number:See footnote5
0161151001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| SAFINAMIDE (SAFINAMIDE MESYLATE) | 50 MG |
| Pharmacovigilance/Monitoring Activity |
|---|
| Drug Utilisation Study (DUS) |