Approval · Notice of Compliance 439 · 2002
FRAGMIN: Notice of Compliance 439
Issued June 10, 2002
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
- 439
- Date
- June 10, 2002
- Company
- Pharmacia Canada Inc.Baie D'Urfe, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised dosage and administration for post-operative initiation of thromboprophylaxis in patients undergoing elective hip surgery at higher risk of perioperative bleeding
- Therapeutic class
- Anticoagulant, antithrombotic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| FRAGMIN | Not yet assigned | — |
Medicinal ingredients
- DALTEPARIN SODIUM 5,000 UNIT per ML
- DALTEPARIN SODIUM 2,500 UNIT per ML