Approval · Notice of Compliance 19542 · 2017
LATUDA: Notice of Compliance 19542
Issued July 20, 2017
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
- 19542
- Date
- July 20, 2017
- Company
- Sunovion Pharmaceuticals Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Expand the indication to adolescents (age 15-17) with schizophrenia
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