Approval · Notice of Compliance 9657 · 2008
RALIVIA: Notice of Compliance 9657
Issued July 2, 2008
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
- 9657
- Date
- July 2, 2008
- Company
- Biovail Pharmaceuticals Canada Division Of Biovail CorporationMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revision to the indication from pain of moderate severity to moderate to moderately severe pain
- Therapeutic class
- Opioid analgesic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RALIVIA | Not yet assigned | — |
Medicinal ingredients
- TRAMADOL HCL 100 MG per TAB
- TRAMADOL HCL 200 MG per TAB
- TRAMADOL HCL 300 MG per TAB