Approval · Notice of Compliance 35994 · 2025
AMIODARONE: Notice of Compliance 35994
Issued September 12, 2025
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
- 35994
- Date
- September 12, 2025
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Admin
- Reason
- Administrative: Update to labelling (to match Licensor)
- Canadian reference product
- CORDARONE (Wyeth-Ayerst Canada Inc.)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AMIODARONE | Not yet assigned | — |
Medicinal ingredients
- AMIODARONE HYDROCHLORIDE 200 MG per TAB