Approval · Notice of Compliance 38372 · 2023
RISPERIDONE: Notice of Compliance 38372
Issued September 28, 2023
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
- 38372
- Date
- September 28, 2023
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Administrative: Licensing Agreement between two manufacturers
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERIDONE | 02533804 | Marketed |
| RISPERIDONE | 02533928 | Marketed |
| RISPERIDONE | 02533936 | Marketed |
| RISPERIDONE | 02533944 | Marketed |
| RISPERIDONE | 02533952 | Marketed |
| RISPERIDONE | 02533960 | Marketed |
| RISPERIDONE | Not yet assigned | — |
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
- RISPERIDONE TARTRATE 1 MG per ML