Approval · Notice of Compliance 21413 · 2018
REBINYN: Notice of Compliance 21413
Issued October 16, 2018
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
- 21413
- Date
- October 16, 2018
- 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 manufacturing 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