Approval · Notice of Compliance 4861 · 1995
KOGENATE: Notice of Compliance 4861
Issued August 4, 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
- 4861
- Date
- August 4, 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 thge labelling and product monograph
- Therapeutic class
- Coagulation factor
Products in this notice
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 250 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1,000 UNIT per VIAL