Approval · Notice of Compliance 3685 · 1997
BENEFIX: Notice of Compliance 3685
Issued March 21, 1997
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
- 3685
- Date
- March 21, 1997
- Company
- Genetics Institute Inc
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Priority-NAS
- Therapeutic class
- Antihemorrhagic blood coagulation factor ix
Products in this notice
Medicinal ingredients
- COAGULATION FACTOR IX (RECOMBINANT) 250 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT) 500 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT) 1,000 UNIT per VIAL
- WATER 10 ML per VIAL
- WATER 5 ML per VIAL