Approval · Notice of Compliance 8973 · 2007
RISPERDAL CONSTA: Notice of Compliance 8973
Issued August 14, 2007
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
- 8973
- Date
- August 14, 2007
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength: 12.5 mg/vial and other related revisions to the product monograph
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERDAL CONSTA | 02298465 | Marketed |
Medicinal ingredients
- RISPERIDONE 12.5 MG per VIAL