Approval · Notice of Compliance 34379 · 2024
XCOPRI: Notice of Compliance 34379
Issued October 11, 2024
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
- 34379
- Date
- October 11, 2024
- Company
- Endo Operations Ltd.Ballsbridge, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing site and/or manufacturer involving production of the drug substance. Addition of a manufacturing site and/or manufacturer involving production of the intermediate. Addition of a manufacturing site and/or manufacturer involving production of the starting material. Change in the manufacturing process for the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XCOPRI | Not yet assigned | — |
Medicinal ingredients
- CENOBAMATE 12.5 MG per TAB
- CENOBAMATE 25 MG per TAB
- CENOBAMATE 50 MG per TAB
- CENOBAMATE 100 MG per TAB
- CENOBAMATE 150 MG per TAB
- CENOBAMATE 200 MG per TAB
- CENOBAMATE 100 MG per NIL
- CENOBAMATE 150 MG per NIL
- CENOBAMATE 200 MG per NIL
- CENOBAMATE 12.5 MG per NIL
- CENOBAMATE 25 MG per NIL
- CENOBAMATE 50 MG per NIL