Approval · Notice of Compliance 18370 · 2016
ALPROLIX: Notice of Compliance 18370
Issued August 16, 2016
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
- 18370
- Date
- August 16, 2016
- Company
- Biogen Canada IncToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for adults and children with hemophilia B (congenital factor ix deficiency or christmas disease) for: routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes; control and prevention of bleeding episodes; perioperative management (surgical prophylaxis)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ALPROLIX | Not yet assigned | — |
Medicinal ingredients
- RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 250 UNIT per VIAL
- RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 500 UNIT per VIAL
- RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 1,000 UNIT per VIAL
- RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 2,000 UNIT per VIAL
- RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 3,000 UNIT per VIAL