Approval · Notice of Compliance 16583 · 2014
RISPERDAL CONSTA: Notice of Compliance 16583
Issued December 29, 2014
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
- 16583
- Date
- December 29, 2014
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the dosage and administration section of the product monograph to reflect new components in the kit
- 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