Approval · Notice of Compliance 26449 · 2021
PMS-RISPERIDONE: Notice of Compliance 26449
Issued August 17, 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
- 26449
- Date
- August 17, 2021
- Company
- Pharmascience Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph to be in line with Canadian Reference Product. Removal of discontinued product, pms-Risperidone ODT, from the Product Monograph. Update to the package insert
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PMS-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 1 MG per ML