Approval · Notice of Compliance 11661 · 2010
ARTISS (SOLUTION): Notice of Compliance 11661
Issued August 17, 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
- 11661
- Date
- August 17, 2010
- Company
- Baxter CorporationMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product name change
- Therapeutic class
- Hemostatic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ARTISS (SOLUTION) | 02326167 | Marketed |
| ARTISS (SOLUTION) | 02326183 | — |
| ARTISS (KIT) | 02326124 | — |
| ARTISS (KIT) | 02326140 | — |
Medicinal ingredients
- SEALER PROTEIN (HUMAN) 125 MG per ML
- APROTININ (SYNTHETIC) 3,000 KIU per ML
- THROMBIN (HUMAN) 4 UNIT per ML
- CALCIUM CHLORIDE 40 MCMOL per ML
- APROTININ (BOVINE) 3,000 KIU per ML
- SEALER PROTEIN (HUMAN) 125 ML per ML