Approval · Notice of Compliance 4856 · 1995
HELIXATE: Notice of Compliance 4856
Issued October 3, 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
- 4856
- Date
- October 3, 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
- Therapeutic class
- Coagulation factor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HELIXATE | 02185954 | — |
| HELIXATE | 02185962 | — |
| HELIXATE | 02185970 | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,000 UNIT per VIAL