Approval · Notice of Compliance 15466 · 2014
LATUDA: Notice of Compliance 15466
Issued March 31, 2014
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
- 15466
- Date
- March 31, 2014
- Company
- Sunovion Pharmaceuticals Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: the treatment of depressive episodes in bipolar 1 disorder as monotherapy or adjunctive therapy with lithium or valproate
- Therapeutic class
- Antipsychotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LATUDA | Not yet assigned | — |
Medicinal ingredients
- LURASIDONE HYDROCHLORIDE 40 MG per TAB
- LURASIDONE HYDROCHLORIDE 80 MG per TAB
- LURASIDONE HYDROCHLORIDE 120 MG per TAB
- LURASIDONE HYDROCHLORIDE 20 MG per TAB
- LURASIDONE HYDROCHLORIDE 60 MG per TAB