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:
2009-09-17
Original market date: See footnote 1
1985-12-31
Product name:
STATEX TAB 5MG
DIN:
00594652
Product Monograph/Veterinary Labelling:
Date:
2023-06-28
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
PALADIN PHARMA INC.
100 Blvd Alexis-Nihon, Suite 600
Montreal
Quebec
Canada
H4M 2P2
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:08.08
Anatomical Therapeutic Chemical (ATC): See footnote 4
N02AA01 MORPHINE
Active ingredient group (AIG) number:See footnote5
0104545003
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MORPHINE SULFATE | 5 MG |
Risk Management Plans See footnote 7
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |