Approval · Notice of Compliance 30362 · 2023
SUBOXONE: Notice of Compliance 30362
Issued March 17, 2023
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
- 30362
- Date
- March 17, 2023
- Company
- Indivior Uk LimitedHull, --, United Kingdom
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update the Product Monograph (PM) for the XML migration. Update the Package Inserts to align with the Patient Medication Information (PMI).
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUBOXONE | Not yet assigned | — |
Medicinal ingredients
- BUPRENORPHINE HYDROCHLORIDE 2 MG per STRIP
- NALOXONE HYDROCHLORIDE 0.5 MG per STRIP
- BUPRENORPHINE HYDROCHLORIDE 4 MG per STRIP
- NALOXONE HYDROCHLORIDE 1 MG per STRIP
- BUPRENORPHINE HYDROCHLORIDE 8 MG per STRIP
- NALOXONE HYDROCHLORIDE 2 MG per STRIP
- BUPRENORPHINE HYDROCHLORIDE 12 MG per STRIP
- NALOXONE HYDROCHLORIDE 3 MG per STRIP
- BUPRENORPHINE HYDROCHLORIDE 2 MG per TAB
- NALOXONE HYDROCHLORIDE DIHYDRATE 0.5 MG per TAB
- BUPRENORPHINE HYDROCHLORIDE 8 MG per TAB
- NALOXONE HYDROCHLORIDE DIHYDRATE 2 MG per TAB
- BUPRENORPHINE HYDROCHLORIDE 12 MG per TAB
- NALOXONE HYDROCHLORIDE DIHYDRATE 3 MG per TAB
- BUPRENORPHINE HYDROCHLORIDE 16 MG per TAB
- NALOXONE HYDROCHLORIDE DIHYDRATE 4 MG per TAB