Approval · Notice of Compliance 5416 · 2004
ARIXTRA: Notice of Compliance 5416
Issued September 23, 2004
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
- 5416
- Date
- September 23, 2004
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New strength and new indication for the treatment of acute deep vein thrombosis (dvt) and acute pulmonary embolism (pe)
- Therapeutic class
- Synthetic antithrombotic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARIXTRA | 02258056 | Marketed |
Medicinal ingredients
- FONDAPARINUX SODIUM 12.5 MG per ML