Approval · Notice of Compliance 8181 · 2006
FRAGMIN: Notice of Compliance 8181
Issued July 28, 2006
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
- 8181
- Date
- July 28, 2006
- Company
- Pfizer Canada UlcKirkland, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: reduction of deep vein thrombosis (dvt) in hospitalized patients with severely restricted mobility during acute illness
- Therapeutic class
- Anticoagulant / antithrombotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FRAGMIN | Not yet assigned | — |
Medicinal ingredients
- DALTEPARIN SODIUM 10,000 UNIT per ML
- DALTEPARIN SODIUM 25,000 UNIT per ML
- DALTEPARIN SODIUM 2,500 UNIT per 0.2ML
- DALTEPARIN SODIUM 5,000 UNIT per 0.2ML