Approval · Notice of Compliance 7002 · 2005
RISPERDAL M-TAB: Notice of Compliance 7002
Issued May 31, 2005
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
- 7002
- Date
- May 31, 2005
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Two additional strengths and reformulation of the 2mg tablet
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERDAL M-TAB | Not yet assigned | — |
| RISPERDAL M-TAB | 02268086 | Cancelled Post Market |
| RISPERDAL M-TAB | 02268094 | Cancelled Post Market |
Medicinal ingredients
- RISPERIDONE 2 MG per TAB
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 4 MG per TAB