Approval · Notice of Compliance 401 · 2003
BENEFIX: Notice of Compliance 401
Issued April 8, 2003
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
- 401
- Date
- April 8, 2003
- Company
- Wyeth CanadaSt. Laurent, Quebec, Canada
- Product type
- Biologic
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
- 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