Approval · Notice of Compliance 17239 · 2015
SUBOXONE: Notice of Compliance 17239
Issued August 31, 2015
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
- 17239
- Date
- August 31, 2015
- Company
- Indivior Uk LimitedHull, --, United Kingdom
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Inclusion of class labelling text and updates to the indications, contrindications and dosage and administration sections of the product monograph (pm)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SUBOXONE | Not yet assigned | — |
Medicinal ingredients
- BUPRENORPHINE HYDROCHLORIDE 2.16 MG per TAB
- NALOXONE HYDROCHLORIDE DIHYDRATE 0.61 MG per TAB
- BUPRENORPHINE HYDROCHLORIDE 8.64 MG per TAB
- NALOXONE HYDROCHLORIDE DIHYDRATE 2.44 MG per TAB