ALPROLIX DIN 02422948
Status: Marketed
Holder: SANOFI-AVENTIS CANADA INC
Health Canada record
| Active ingredient(s) | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 2000 UNIT |
|---|---|
| Dosage form | Powder For Solution; Kit |
| Route | Intravenous |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | B02BD04 COAGULATION FACTOR IX |
| Original market date | 11-Dec-2015 |
| Current status date | 22-Sep-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
sanofi-aventis Canada Inc. — licence 101470, currently licensed, last inspection rating C (2026-02-17).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02422905 | ALPROLIX | SANOFI-AVENTIS CANADA INC | Powder For Solution; Kit | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 250 UNIT | Approved |
| 02422913 | ALPROLIX | SANOFI-AVENTIS CANADA INC | Powder For Solution; Kit | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 500 UNIT | Marketed |
| 02474034 | ALPROLIX | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 4000 UNIT | Approved |
| 02422956 | ALPROLIX | SANOFI-AVENTIS CANADA INC | Powder For Solution; Kit | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 3000 UNIT | Marketed |
| 02422921 | ALPROLIX | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 1000 UNIT | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19311 | 2017-05-17 | New Drug Submission (NDS) | MERGER - BUYOUT |
| 15435 | 2014-03-20 | New Drug Submission (NDS) |