Approval · Notice of Compliance 8620 · 2007
ARIXTRA: Notice of Compliance 8620
Issued February 27, 2007
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
- 8620
- Date
- February 27, 2007
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: management of st-segment elevation myocardial infarction (stemi) for the prevention of death and myocardial re-infarction, new intravenous route of administration, and other revisions to the product monograph
- 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