Approval · Notice of Compliance 31192 · 2023
ALERTEC: Notice of Compliance 31192
Issued July 7, 2023
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
- 31192
- Date
- July 7, 2023
- Company
- Teva Canada LimitedToronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update the WARNINGS AND PRECAUTIONS and PATIENT MEDICATION INFORMATION sections of the Product Monograph (PM) to add the risk of dependence/tolerance in patients with a history of psychiatric disorders.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ALERTEC | Not yet assigned | — |
Medicinal ingredients
- MODAFINIL 100 MG per TAB