Approval · Notice of Compliance 34740 · 2025
XYREM: Notice of Compliance 34740
Issued January 23, 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
- 34740
- Date
- January 23, 2025
- Company
- Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XYREM | Not yet assigned | — |
Medicinal ingredients
- SODIUM OXYBATE 500 MG per ML