Approval · Notice of Compliance 21307 · 2018
APTIOM: Notice of Compliance 21307
Issued September 12, 2018
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
- 21307
- Date
- September 12, 2018
- Company
- Sunovion Pharmaceuticals Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of the indication to include adjunctive therapy for the treatment of partial onset seizures in adolescents and children (above 6 years of age)
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