Approval · Notice of Compliance 35655 · 2025
LAMOTRIGINE: Notice of Compliance 35655
Issued July 11, 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
- 35655
- Date
- July 11, 2025
- Company
- Sivem Pharmaceuticals UlcSaint-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to an Abbreviated New Drug Submission (SANDS), supplement
- Submission class
- Other
- Reason
- Administrative: Update to labelling (to match Licensor)
- Canadian reference product
- LAMICTAL (Glaxosmithkline Inc)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| LAMOTRIGINE | Not yet assigned | — |
Medicinal ingredients
- LAMOTRIGINE 150 MG per TAB
- LAMOTRIGINE 100 MG per TAB
- LAMOTRIGINE 25 MG per TAB