Approval · Notice of Compliance 28865 · 2022
VYXEOS: Notice of Compliance 28865
Issued August 31, 2022
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
- 28865
- Date
- August 31, 2022
- Company
- Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in the specification for the drug product tests and acceptance criteria.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VYXEOS | Not yet assigned | — |
Medicinal ingredients
- CYTARABINE 100 MG per VIAL
- DAUNORUBICIN 44 MG per VIAL