Approval · Notice of Compliance 16716 · 2015
SANDOZ RISPERIDONE: Notice of Compliance 16716
Issued March 19, 2015
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
- 16716
- Date
- March 19, 2015
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Revisions to the product monograph
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL; (Janssen-Ortho Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| SANDOZ RISPERIDONE | Not yet assigned | — |
Medicinal ingredients
- RISPERIDONE 0.25 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 2 MG per TAB
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 4 MG per TAB
- RISPERIDONE 0.5 MG per TAB