Approval · Notice of Compliance 25460 · 2021
REBINYN: Notice of Compliance 25460
Issued March 17, 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
- 25460
- Date
- March 17, 2021
- Company
- Novo Nordisk Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes to the manuufacturing process
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REBINYN | Not yet assigned | — |
Medicinal ingredients
- COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 500 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 1,000 UNIT per VIAL
- COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 2,000 UNIT per VIAL