Approval · Notice of Compliance 15523 · 2014
RISEDRONATE: Notice of Compliance 15523
Issued April 23, 2014
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
- 15523
- Date
- April 23, 2014
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement between two companies
- Therapeutic class
- Bone metabolism regulator
- Canadian reference product
- ACTONEL (Procter & Gamble Pharmaceuticals Canada, Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISEDRONATE | 02370239 | Cancelled Pre Market |
| RISEDRONATE | 02370247 | Cancelled Pre Market |
| RISEDRONATE | 02370255 | Marketed |
Medicinal ingredients
- RISEDRONATE SODIUM MONOHYDRATE 5 MG per TAB
- RISEDRONATE SODIUM MONOHYDRATE 30 MG per TAB
- RISEDRONATE SODIUM MONOHYDRATE 35 MG per TAB