Approval · Notice of Compliance 8596 · 2007
PMS-RISPERIDONE ODT: Notice of Compliance 8596
Issued February 19, 2007
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
- 8596
- Date
- February 19, 2007
- Company
- Pharmascience Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- New dosage form
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL M-TAB (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PMS-RISPERIDONE ODT | 02291770 | Cancelled Post Market |
| PMS-RISPERIDONE ODT | 02291789 | Cancelled Post Market |
| PMS-RISPERIDONE ODT | 02291797 | Cancelled Post Market |
Medicinal ingredients
- RISPERIDONE 0.5 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 2 MG per TAB