Approval · Notice of Compliance 20751 · 2018
LATUDA: Notice of Compliance 20751
Issued April 19, 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
- 20751
- Date
- April 19, 2018
- Company
- Sunovion Pharmaceuticals Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To add an indication to the product monograph related to deprfessive episodes associated with bipolar 1 disorded in the pediatric population
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LATUDA | Not yet assigned | — |
Medicinal ingredients
- LURASIDONE HYDROCHLORIDE 20 MG per TAB
- LURASIDONE HYDROCHLORIDE 40 MG per TAB
- LURASIDONE HYDROCHLORIDE 60 MG per TAB
- LURASIDONE HYDROCHLORIDE 80 MG per TAB
- LURASIDONE HYDROCHLORIDE 120 MG per TAB