Approval · Notice of Compliance 15612 · 2014
TRETTEN: Notice of Compliance 15612
Issued May 20, 2014
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
- 15612
- Date
- May 20, 2014
- Company
- Novo Nordisk Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Extension of the indication: tretten (catridecacog) is indicated for routine prophylaxis for bleeding in adult and pediatric patients with congenital factor xiii A-subunit deficiency
- Therapeutic class
- Coagulation factor
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRETTEN | Not yet assigned | — |
Medicinal ingredients
- CATRIDECACOG 15 MG per VIAL