Approval · Notice of Compliance 20107 · 2017
XYREM: Notice of Compliance 20107
Issued November 27, 2017
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
- 20107
- Date
- November 27, 2017
- Company
- Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Administrative: Transfer of Drug Identification Number
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| XYREM | 02268272 | Marketed |
Medicinal ingredients
- SODIUM OXYBATE 500 MG per ML