WAKIX DIN 02516268
Status: Marketed
Holder: KNIGHT THERAPEUTICS INC.
Molecule: PITOLISANT HYDROCHLORIDE
Available to quote
Health Canada record
| Active ingredient(s) | PITOLISANT HYDROCHLORIDE 20 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N07XX11 PITOLISANT |
| Original market date | 31-Dec-2021 |
| Current status date | 12-May-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Knight Therapeutics Inc. — licence 3-002350, currently licensed, last inspection rating C (2025-11-05).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PITOLISANT HYDROCHLORIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02516241 | WAKIX | KNIGHT THERAPEUTICS INC. | Tablet | PITOLISANT HYDROCHLORIDE 5 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 37522 | 2026-05-12 | New Drug Submission (NDS) | Administrative: Change in product ownership |
| 28132 | 2021-05-25 | New Drug Submission (NDS) |
International API supply for PITOLISANT HYDROCHLORIDE
6 active FDA Drug Master Files.
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