Approval · Notice of Compliance 12967 · 2011
MULTAQ: Notice of Compliance 12967
Issued November 21, 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
- 12967
- Date
- November 21, 2011
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the indications: Treatment of patients with paroxysmal or persistent atrial fibrillation who are in sinus rhythm or who are intended to be cardioverted to reduce the risk of cardiovascular hospitalization due to arterial fibrillation. Multaq should only be prescribed after alternative treatment options have been considered.
- Therapeutic class
- Antiarrhythmic Agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| MULTAQ | Not yet assigned | — |
Medicinal ingredients
- DRONEDARONE HYDROCHLORIDE 400 MG per TAB