Approval · Notice of Compliance 8591 · 2007
CORDARONE: Notice of Compliance 8591
Issued February 15, 2007
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
- 8591
- Date
- February 15, 2007
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revisions to the dosage recommendation for special populations in the warning and precautions section and other revisions to the product monograph
- Therapeutic class
- Antiarrhythmic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| CORDARONE | Not yet assigned | — |
Medicinal ingredients
- AMIODARONE HYDROCHLORIDE 200 MG per TAB