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:
2016-03-10
Original market date: See footnote 1
2007-11-26
Product name:
SUBOXONE
DIN:
02295695
Product Monograph/Veterinary Labelling:
Date:
2023-03-16
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
INDIVIOR UK LIMITED
The Chapleo Building, Henry Boot Way
Hull
--
United Kingdom
HU4 7DY
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Sublingual
Number of active ingredient(s):
2
Schedule(s):
Narcotic (CDSA I)
American Hospital Formulary Service (AHFS): See footnote 3
28:10.00 , 28:08.12
Anatomical Therapeutic Chemical (ATC): See footnote 4
N07BC51 BUPRENORPHINE, COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0252216001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) | 2 MG |
| NALOXONE (NALOXONE HYDROCHLORIDE DIHYDRATE) | 0.5 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
A Canadian Specific Opioid targeted Risk Management Plan (CSO-tRMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |