Approval · Notice of Compliance 14408 · 2013
ABILIFY: Notice of Compliance 14408
Issued May 29, 2013
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
- 14408
- Date
- May 29, 2013
- 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 for the use as an adjunct to antidepressants for the treatment of Major Depressinve Disorder (MDD) in adult patients who had an inadequate reponse to prior antidepressant treatments during the current episode
- Therapeutic class
- Antiphsychotic
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