Approval · Notice of Compliance 20828 · 2018
RISPERDAL: Notice of Compliance 20828
Issued May 4, 2018
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
- 20828
- Date
- May 4, 2018
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of safety statements to part iii to align with part i and to remove discontiuation of all strengths of risperdal m-tab (0.5, 1,2,3 and 4 mg) from product monograph. updates to package inserts
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 1 MG per ML