Approval · Notice of Compliance 16138 · 2011
WILATE: Notice of Compliance 16138
Issued September 9, 2011
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
- 16138
- Date
- September 9, 2011
- Company
- Octapharma Pharmazeutika Produktionsges M B HVienna, Vienne, Austria
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication for von willebrand disease
- Therapeutic class
- Hemostatic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| WILATE | Not yet assigned | — |
Medicinal ingredients
- HUMAN PLASMA PROTEINS 15 MG per 10ML
- VON WILLEBRAND FACTOR (HUMAN) 800 UNIT per 10ML
- ANTIHEMOPHILIC FACTOR (HUMAN) 450 UNIT per 5ML
- HUMAN PLASMA PROTEINS 7.5 MG per 5ML
- VON WILLEBRAND FACTOR (HUMAN) 400 UNIT per 5ML
- ANTIHEMOPHILIC FACTOR (HUMAN) 900 UNIT per 10ML