Approval · Notice of Compliance 30815 · 2023
WAKIX: Notice of Compliance 30815
Issued May 24, 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
- 30815
- Date
- May 24, 2023
- Company
- Endo Ventures Ltd
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of new information for women breastfeeding while taking WAKIX. Update Product Monograph (PM) to the 2020 PM Master Template.
- Canadian reference product
- CRESTOR (Astrazeneca Canada Inc)
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