Approval · Notice of Compliance 33100 · 2024
ESPEROCT: Notice of Compliance 33100
Issued April 23, 2024
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
- 33100
- Date
- April 23, 2024
- Company
- Novo Nordisk Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a drug product manufacturing site
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ESPEROCT | Not yet assigned | — |
Medicinal ingredients
- ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 1,500 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 2,000 UNIT per VIAL
- ANTIHEMOPHILIC FACTOR VIII (RECOMBINANT, B-DOMAIN TRUNCATED), PEGYLATED 3,000 UNIT per VIAL