Approval · Notice of Compliance 28206 · 2022
ALPROLIX: Notice of Compliance 28206
Issued May 17, 2022
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
- 28206
- Date
- May 17, 2022
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of an alternate drug substance manufacturing site
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
- RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 4,000 UNIT per VIAL