Approval · Notice of Compliance 5412 · 2003
RISPERDAL: Notice of Compliance 5412
Issued December 5, 2003
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
- 5412
- Date
- December 5, 2003
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the product monograph regarding cerebrovascular adverse events in dementia trials of risperidone in elderly patients
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERDAL | Not yet assigned | — |
| RISPERDAL M-TAB | 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 5 MG per TAB
- RISPERIDONE 1 MG per ML