Approval · Notice of Compliance 26196 · 2021
ALPROLIX: Notice of Compliance 26196
Issued July 2, 2021
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
- 26196
- Date
- July 2, 2021
- 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 manufacturing site and an alternate quality control testing site for the drug product
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