Approval · Notice of Compliance 36466 · 2025
SUBLOCADE: Notice of Compliance 36466
Issued December 2, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 36466
- Date
- December 2, 2025
- Company
- Indivior Uk LimitedHull, --, United Kingdom
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in recommended dose/dosing range. Change to existing indication: Sublocade (buprenorphine solution (extendedrelease) for injection) is indicated for the management of moderate to severe opioid use disorder in adult patients. Sublocade should be used as part of a complete treatment plan that includes counselling and psychosocial support. Sublocade must only be administered subcutaneously in the abdominal region by a healthcare professional. Update to the Product Monograph with new safety information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUBLOCADE | Not yet assigned | — |
Medicinal ingredients
- BUPRENORPHINE 100 MG per 0.5ML
- BUPRENORPHINE 300 MG per 1.5ML