Approval · Notice of Compliance 14498 · 2013
RIVA-RISPERIDONE: Notice of Compliance 14498
Issued June 26, 2013
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
- 14498
- Date
- June 26, 2013
- Company
- Laboratoire Riva Inc.Blainville, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Administrative licensing agreement between two companies
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RIVA-RISPERIDONE | 02283565 | Marketed |
| RIVA-RISPERIDONE | 02283573 | Dormant |
| RIVA-RISPERIDONE | 02283581 | Marketed |
| RIVA-RISPERIDONE | 02283603 | Marketed |
| RIVA-RISPERIDONE | 02283611 | Marketed |
| RIVA-RISPERIDONE | 02283638 | Marketed |
Medicinal ingredients
- RISPERIDONE 0.25 MG per TAB
- RISPERIDONE 0.5 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 2 MG per TAB
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 4 MG per TAB