Approval · Notice of Compliance 19998 · 2017
ABILIFY MAINTENA: Notice of Compliance 19998
Issued November 2, 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
- 19998
- Date
- November 2, 2017
- 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
- New indication: for the maintenance monotherapy treatment of bipolar I in adults
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ABILIFY MAINTENA | Not yet assigned | — |
Medicinal ingredients
- ARIPIPRAZOLE 300 MG per VIAL
- ARIPIPRAZOLE 400 MG per VIAL
- ARIPIPRAZOLE 300 MG per SYR
- ARIPIPRAZOLE 400 MG per SYR