Approval · Notice of Compliance 12532 · 2011
PMS-RISPERIDONE ODT: Notice of Compliance 12532
Issued August 2, 2011
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
- 12532
- Date
- August 2, 2011
- 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 Strengths; Revisions to the Product Monograph
- Therapeutic class
- Antipsychotic Agent
- Canadian reference product
- RISPERDAL M-TAB (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PMS-RISPERIDONE ODT | 02370697 | Cancelled Post Market |
| PMS-RISPERIDONE ODT | 02370700 | Cancelled Post Market |
Medicinal ingredients
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 4 MG per TAB