Approval · Notice of Compliance 10836 · 2009
RISPERDAL CONSTA: Notice of Compliance 10836
Issued December 2, 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
- 10836
- Date
- December 2, 2009
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Bipolar Disorder, Risperdal Consta is indicated as monotherapy maintenance treatment in patients with bipolar 1 disorder to delay occurrence of manic episodes
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERDAL CONSTA | Not yet assigned | — |
Medicinal ingredients
- RISPERIDONE 12.5 MG per VIAL
- RISPERIDONE 25 MG per VIAL
- RISPERIDONE 37.5 MG per VIAL
- RISPERIDONE 50 MG per VIAL