Approval · Notice of Compliance 29755 · 2022
RISPERIDONE: Notice of Compliance 29755
Issued December 21, 2022
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
- 29755
- Date
- December 21, 2022
- 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 Companies
- 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 |
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