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:
2020-02-03
Original market date: See footnote 1
2020-02-03
Product name:
SUBLOCADE
Description:
PREFILLED SYRINGE & POUCH - SINGLE DOSE
DIN:
02483092
Product Monograph/Veterinary Labelling:
Date:
2022-07-05
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):
Solution (Extended Release)
Route(s) of administration:
Subcutaneous
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
N07BC01 BUPRENORPHINE
Active ingredient group (AIG) number:See footnote5
0142241016
| Active ingredient(s) | Strength |
|---|---|
| BUPRENORPHINE | 300 MG / 1.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Controlled Distribution Program |