Approval · Notice of Compliance 22977 · 2019
DEFITELIO: Notice of Compliance 22977
Issued December 4, 2019
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
- 22977
- Date
- December 4, 2019
- Company
- Jazz Pharmaceuticals Ireland LimitedDublin, Dublin, Ireland
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: defitelio solution for intravenous infusion is indicated for the treatment of adult and pediatric patients with severe hepatic veno-occlusive disease (vod) also know as sinusoidal obstruction syndrome (sos) following haematopoietic stem-cell transplantation (hsct)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| DEFITELIO | Not yet assigned | — |
Medicinal ingredients
- DEFIBROTIDE 80 MG per ML