Approval · Notice of Compliance 23925 · 2020
SUBOXONE: Notice of Compliance 23925
Issued July 17, 2020
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
- 23925
- Date
- July 17, 2020
- Company
- Indivior Uk LimitedHull, --, United Kingdom
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Approval of sublingual/buccal soluble film (strengths: 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg).
Products in this notice
Medicinal ingredients
- BUPRENORPHINE HYDROCHLORIDE 2.16 MG per UNIT
- NALOXONE HYDROCHLORIDE DIHYDRATE 0.61 MG per UNIT
- BUPRENORPHINE HYDROCHLORIDE 4.32 MG per UNIT
- NALOXONE HYDROCHLORIDE DIHYDRATE 1.22 MG per UNIT
- BUPRENORPHINE HYDROCHLORIDE 8.64 MG per UNIT
- NALOXONE HYDROCHLORIDE DIHYDRATE 2.44 MG per UNIT
- BUPRENORPHINE HYDROCHLORIDE 12.96 MG per UNIT
- NALOXONE HYDROCHLORIDE DIHYDRATE 3.66 MG per UNIT