Approval · Notice of Compliance 4850 · 1995
KOATE-HP: Notice of Compliance 4850
Issued November 17, 1995
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
- 4850
- Date
- November 17, 1995
- Company
- Bayer Inc.Elkhart, Indiana, United States
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Change in manufacturer's name - changes to the product monograph
- Therapeutic class
- Coagulation factor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KOATE-HP | 02187825 | — |
| KOATE-HP | 02187833 | — |
| KOATE-HP | 02187841 | Cancelled Post Market |
| KOATE-HP | 02187868 | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (HUMAN) 250 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (HUMAN) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (HUMAN) 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (HUMAN) 1,500 UNIT per VIAL