Approval · Notice of Compliance 16312 · 2014
RISPERDAL: Notice of Compliance 16312
Issued November 12, 2014
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
- 16312
- Date
- November 12, 2014
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Restrict indication to those patients with severe dementia of the alzheimer's type unresponsive to non-pharmacological approaches and where there is a risk of harm to others
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERDAL | 02240551 | Cancelled Post Market |
| RISPERDAL | 02240552 | Cancelled Post Market |
| RISPERDAL | 02025280 | Cancelled Post Market |
| RISPERDAL | 02025310 | Cancelled Post Market |
| RISPERDAL | 02025302 | Cancelled Post Market |
| RISPERDAL | 02236950 | Cancelled Post Market |
| RISPERDAL M-TAB | 02247704 | Cancelled Post Market |
| RISPERDAL M-TAB | 02247705 | Cancelled Post Market |
| RISPERDAL M-TAB | 02247706 | Cancelled Post Market |
| RISPERDAL M-TAB | 02268086 | Cancelled Post Market |
| RISPERDAL M-TAB | 02268094 | 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
- RISPERIDONE 1 MG per ML