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:
2022-11-17
Original market date: See footnote 1
2021-08-03
Product name:
SUNOSI
DIN:
02515814
Product Monograph/Veterinary Labelling:
Date:
2022-08-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AXSOME MALTA LTD.
Pinto Business Centre, Level 4, Office 4, Mill Street
Qormi
--
Malta
QRM3104
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
28:20.80
Anatomical Therapeutic Chemical (ATC): See footnote 4
N06BA14 SOLRIAMFETOL
Active ingredient group (AIG) number:See footnote5
0162888001
| Active ingredient(s) | Strength |
|---|---|
| SOLRIAMFETOL (SOLRIAMFETOL HYDROCHLORIDE) | 75 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.