Approval · Notice of Compliance 11549 · 2010
ARIXTRA: Notice of Compliance 11549
Issued June 14, 2010
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
- 11549
- Date
- June 14, 2010
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph to reflect new study information for patients with moderate liver impairment
- Therapeutic class
- Synthetic antithrombotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARIXTRA | Not yet assigned | — |
Medicinal ingredients
- FONDAPARINUX SODIUM 2.5 MG per 0.5ML
- FONDAPARINUX SODIUM 12.5 MG per ML