Approval · Notice of Compliance 11518 · 2010
EVICEL: Notice of Compliance 11518
Issued June 16, 2010
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
- 11518
- Date
- June 16, 2010
- Company
- Omrix Biopharmaceuticals LtdNess Ziona, --, Israel
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of indication: For use as supportive treatment in surgery where standard techniques are insufficient, for improvement of hemostasis. Evidence of efficacy and safety has been demonstrated in the following clinical trials: liver surgery such as liver resection and reduced-size live transplantation, orthopedic surgery such as total hip replacement and total knee replacement, retroperitoneal / intra-abdominal surgery, and vascular surgery
- Therapeutic class
- Hemostatic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EVICEL | Not yet assigned | — |
Medicinal ingredients
- FIBRINOGEN (HUMAN) 90 MG per ML
- THROMBIN (HUMAN) 1,200 UNIT per ML