Approval · Notice of Compliance 21788 · 2019
APTIOM: Notice of Compliance 21788
Issued January 24, 2019
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
- 21788
- Date
- January 24, 2019
- Company
- Sunovion Pharmaceuticals Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Labelling Only
- Reason
- Addition of new labels with increased size
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| APTIOM | Not yet assigned | — |
Medicinal ingredients
- ESLICARBAZEPINE ACETATE 200 MG per TAB
- ESLICARBAZEPINE ACETATE 400 MG per TAB
- ESLICARBAZEPINE ACETATE 600 MG per TAB
- ESLICARBAZEPINE ACETATE 800 MG per TAB