Approval · Notice of Compliance 29516 · 2022
REBINYN: Notice of Compliance 29516
Issued November 22, 2022
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
- 29516
- Date
- November 22, 2022
- 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 new strength
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REBINYN | Not yet assigned | — |
| REBINYN | 02532964 | Marketed |
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
- COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 3,000 UNIT per VIAL