ELOCTATE DIN 02430320
Status: Marketed
Holder: SANOFI-AVENTIS CANADA INC
Health Canada record
| Active ingredient(s) | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 1000 UNIT |
|---|---|
| Dosage form | Kit; Powder For Solution |
| Route | Intravenous |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | B02BD02 COAGULATION FACTOR VIII |
| Original market date | 15-Jan-2016 |
| Current status date | 03-Nov-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 ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02430290 | ELOCTATE | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 250 UNIT | Marketed |
| 02430304 | ELOCTATE | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 500 UNIT | Marketed |
| 02430312 | ELOCTATE | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 750 UNIT | Marketed |
| 02430339 | ELOCTATE | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 1500 UNIT | Marketed |
| 02430347 | ELOCTATE | SANOFI-AVENTIS CANADA INC | Kit; Powder For Solution | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 2000 UNIT | Marketed |
| 02430355 | ELOCTATE | SANOFI-AVENTIS CANADA INC | Powder For Solution; Kit | ANTIHEMOPHILIC FACTOR (RECOMBINANT BDD), FC FUSION PROTEIN 3000 UNIT | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19312 | 2017-05-17 | New Drug Submission (NDS) | MERGER - BUYOUT |
| 15991 | 2014-08-22 | New Drug Submission (NDS) |