Approval · Notice of Compliance 26748 · 2021
APO-RISPERIDONE: Notice of Compliance 26748
Issued September 29, 2021
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
- 26748
- Date
- September 29, 2021
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Updates to Product Monograph. Updates to Labelling Material.
- Canadian reference product
- RISPERDAL, RISPERDAL ORAL SOLUTION (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APO-RISPERIDONE | Not yet assigned | — |
Medicinal ingredients
- RISPERIDONE 1 MG per ML
- RISPERIDONE 0.5 MG per TAB
- RISPERIDONE 2 MG per TAB
- RISPERIDONE 4 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 0.25 MG per TAB