Approval · Notice of Compliance 10466 · 2009
MYLAN-RISPERIDONE: Notice of Compliance 10466
Issued August 5, 2009
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
- 10466
- Date
- August 5, 2009
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Abbreviated New Drug Submission (ANDS)
- Submission class
- Admin
- Reason
- Manufacturer and product name change
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MYLAN-RISPERIDONE | 02282240 | Cancelled Post Market |
| MYLAN-RISPERIDONE | 02282259 | Cancelled Post Market |
| MYLAN-RISPERIDONE | 02282267 | Cancelled Post Market |
| MYLAN-RISPERIDONE | 02282275 | Cancelled Post Market |
| MYLAN-RISPERIDONE | 02282283 | Cancelled Post Market |
| MYLAN-RISPERIDONE | 02282291 | 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