ESPEROCT DIN 02490102
Status: Marketed
Holder: NOVO NORDISK CANADA INC
Health Canada record
| Active ingredient(s) | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 3000 UNIT |
|---|---|
| Dosage form | Powder For Solution |
| Route | Intravenous |
| Schedule | SCHEDULE D |
| Class | Human |
| ATC | B02BD02 COAGULATION FACTOR VIII |
| Original market date | 15-Sep-2022 |
| Current status date | 15-Sep-2022 |
| Source | Health Canada DPD |
Establishment licence of the holder
Novo Nordisk Canada Inc — licence 100175, currently licensed, last inspection rating C (2023-02-13).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02490064 | ESPEROCT | NOVO NORDISK CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 500 UNIT | Marketed |
| 02490072 | ESPEROCT | NOVO NORDISK CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1000 UNIT | Marketed |
| 02490080 | ESPEROCT | NOVO NORDISK CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1500 UNIT | Approved |
| 02490099 | ESPEROCT | NOVO NORDISK CANADA INC | Powder For Solution | ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 2000 UNIT | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 22386 | 2019-07-04 | New Drug Submission (NDS) |