Approval · Notice of Compliance 12289 · 2011
SUBOXONE: Notice of Compliance 12289
Issued April 26, 2011
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
- 12289
- Date
- April 26, 2011
- Company
- Rb Pharmaceuticals LimitedSlough, Berkshire, United Kingdom
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- Therapeutic class
- Partial opiate agonist and opiate antagonist
Products in this notice
Medicinal ingredients
- 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