Approval · Notice of Compliance 9654 · 2008
PRO-RISPERIDONE: Notice of Compliance 9654
Issued July 2, 2008
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
- 9654
- Date
- July 2, 2008
- Company
- Pro Doc LimiteeLaval, 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 |
|---|---|---|
| PRO-RISPERIDONE | 02312700 | Marketed |
| PRO-RISPERIDONE | 02312719 | Marketed |
| PRO-RISPERIDONE | 02312727 | Marketed |
| PRO-RISPERIDONE | 02312735 | Marketed |
| PRO-RISPERIDONE | 02312743 | Marketed |
| PRO-RISPERIDONE | 02312751 | Marketed |
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