Approval · Notice of Compliance 8177 · 2006
PHL-RISPERIDONE: Notice of Compliance 8177
Issued July 27, 2006
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
- 8177
- Date
- July 27, 2006
- Company
- Pharmel Inc.Montreal, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- New manufacturer and product name
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PHL-RISPERIDONE | 02258439 | Cancelled Post Market |
| PHL-RISPERIDONE | 02258447 | Cancelled Post Market |
| PHL-RISPERIDONE | 02258455 | Cancelled Post Market |
| PHL-RISPERIDONE | 02258463 | Cancelled Post Market |
| PHL-RISPERIDONE | 02258471 | Cancelled Post Market |
| PHL-RISPERIDONE | 02258498 | Cancelled Post Market |
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