Approval · Notice of Compliance 34802 · 2025
NB-RISPERIDONE: Notice of Compliance 34802
Issued February 7, 2025
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
- 34802
- Date
- February 7, 2025
- Company
- NB Pharma Inc.Québec, 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 |
|---|---|---|
| NB-RISPERIDONE | 02555352 | Approved |
| NB-RISPERIDONE | 02555360 | Approved |
| NB-RISPERIDONE | 02555379 | Approved |
| NB-RISPERIDONE | 02555387 | Approved |
| NB-RISPERIDONE | 02555395 | Approved |
| NB-RISPERIDONE | 02555409 | Approved |
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