Approval · Notice of Compliance 20833 · 2018
ARIXTRA: Notice of Compliance 20833
Issued May 4, 2018
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
- 20833
- Date
- May 4, 2018
- Company
- Aspen Pharmacare Canada Inc.Oakville, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in finished product manufacturing process
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARIXTRA | Not yet assigned | — |
Medicinal ingredients
- FONDAPARINUX SODIUM 2.5 MG per 0.5ML
- FONDAPARINUX SODIUM 5 MG per 0.4ML
- FONDAPARINUX SODIUM 7.5 MG per 0.6ML
- FONDAPARINUX SODIUM 10 MG per 0.8ML