Approval · Notice of Compliance 12412 · 2011
ABILIFY: Notice of Compliance 12412
Issued May 12, 2011
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
- 12412
- Date
- May 12, 2011
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: To use as cotherapy with lithium or divalproex sodium for maintaining clinical improvement for up to 1 year in patients with manic or mixed episodes associated with Bipolar I Disorder
- Therapeutic class
- Antipsychotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ABILIFY | Not yet assigned | — |
Medicinal ingredients
- ARIPIPRAZOLE 2 MG per TAB
- ARIPIPRAZOLE 5 MG per TAB
- ARIPIPRAZOLE 10 MG per TAB
- ARIPIPRAZOLE 15 MG per TAB
- ARIPIPRAZOLE 20 MG per TAB
- ARIPIPRAZOLE 30 MG per TAB