Approval · Notice of Compliance 19178 · 2017
ARIXTRA: Notice of Compliance 19178
Issued April 18, 2017
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
- 19178
- Date
- April 18, 2017
- Company
- Aspen Pharmacare Canada Inc.Oakville, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Transfer of drug identification numbers
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARIXTRA | 02245531 | Marketed |
| ARIXTRA (0.4ML SINGLE USE PRE-FILLED SYRINGE) | 02451700 | Dormant |
| ARIXTRA (0.6ML SINGLE USE PRE-FILLED SYRINGE) | 02258056 | Marketed |
| ARIXTRA (0.8ML SINGLE USE PRE-FILLED SYRINGE) | 02451719 | Dormant |
Medicinal ingredients
- FONDAPARINUX SODIUM 2.5 MG per 0.5ML
- FONDAPARINUX SODIUM 12.5 MG per ML
- FONDAPARINUX SODIUM 7.5 MG per 0.6ML
- FONDAPARINUX SODIUM 10 MG per 0.8ML