Approval · Notice of Compliance 6386 · 2005
RISPERDAL: Notice of Compliance 6386
Issued March 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
- 6386
- Date
- March 31, 2005
- Company
- Janssen-Ortho Inc.
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication as monotherapy for the management of acute episodes associated with bipolar i disorder
- Therapeutic class
- Antipsychotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RISPERDAL | Not yet assigned | — |
| RISPERDAL M-TAB | Not yet assigned | — |
Medicinal ingredients
- RISPERIDONE 0.25 MG per TAB
- RISPERIDONE 0.5 MG per TAB
- RISPERIDONE 1 MG per TAB
- RISPERIDONE 2 MG per TAB
- RISPERIDONE 3 MG per TAB
- RISPERIDONE 4 MG per TAB
- RISPERIDONE 5 MG per TAB
- RISPERIDONE 1 MG per ML