Approval · Notice of Compliance 16893 · 2015
MYLAN-RISPERIDONE: Notice of Compliance 16893
Issued May 8, 2015
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
- 16893
- Date
- May 8, 2015
- Company
- Mylan Pharmaceuticals UlcEtobicoke, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Updates to the product monograph
- Therapeutic class
- Antipsychotic agent
- Canadian reference product
- RISPERDAL, RISPERDAL M-TAB
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MYLAN-RISPERIDONE | Not yet assigned | — |
| MYLAN-RISPERIDONE ODT | 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