Approval · Notice of Compliance 18395 · 2016
WILATE: Notice of Compliance 18395
Issued August 19, 2016
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
- 18395
- Date
- August 19, 2016
- 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
- Extension of indication
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| WILATE | Not yet assigned | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (HUMAN) 500 UNIT per 5ML
- HUMAN PLASMA PROTEINS 7.5 MG per 5ML
- VON WILLEBRAND FACTOR (HUMAN) 500 UNIT per 5ML
- ANTIHEMOPHILIC FACTOR (HUMAN) 1,000 UNIT per 10ML
- HUMAN PLASMA PROTEINS 15 MG per 10ML
- VON WILLEBRAND FACTOR (HUMAN) 1,000 UNIT per 10ML