Approval · Notice of Compliance 32585 · 2024
REXULTI: Notice of Compliance 32585
Issued January 23, 2024
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
- 32585
- Date
- January 23, 2024
- Company
- Otsuka Pharmaceutical Co LtdChiyoda-Ku Tokyo, --, Japan
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To get approval for a new indication for the treatment of Agitation associated with Alzheimer¿s Disease (AAD). Product Monograph update to master template.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REXULTI | Not yet assigned | — |
Medicinal ingredients
- BREXPIPRAZOLE 0.25 MG per TAB
- BREXPIPRAZOLE 0.5 MG per TAB
- BREXPIPRAZOLE 1 MG per TAB
- BREXPIPRAZOLE 2 MG per TAB
- BREXPIPRAZOLE 3 MG per TAB
- BREXPIPRAZOLE 4 MG per TAB