Approval · Notice of Compliance 10830 · 2009
DOM-RISPERIDONE: Notice of Compliance 10830
Issued December 4, 2009
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
- 10830
- Date
- December 4, 2009
- Company
- Dominion PharmacalMontreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- New dosage form
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DOM-RISPERIDONE | 02309572 | Cancelled Pre Market |
Medicinal ingredients
- RISPERIDONE TARTRATE 1 MG per ML