Approval · Notice of Compliance 14810 · 2013
RISPERIDONE: Notice of Compliance 14810
Issued October 11, 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
- 14810
- Date
- October 11, 2013
- Company
- Sanis Health Inc.Brampton, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Licensing agreement bvetween two companies
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERIDONE | 02356880 | Marketed |
| RISPERIDONE | 02356899 | Marketed |
| RISPERIDONE | 02356902 | Marketed |
| RISPERIDONE | 02356910 | Marketed |
| RISPERIDONE | 02356929 | Marketed |
| RISPERIDONE | 02356937 | 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