Approval · Notice of Compliance 34845 · 2025
WAKIX: Notice of Compliance 34845
Issued February 14, 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
- 34845
- Date
- February 14, 2025
- Company
- Endo Ventures Ltd
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new indication: treatment of excessive daytime sleepiness in adult patients with obstructive sleep apnea (truncated text)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| WAKIX | Not yet assigned | — |
Medicinal ingredients
- PITOLISANT HYDROCHLORIDE 20 MG per TAB
- PITOLISANT HYDROCHLORIDE 5 MG per TAB