Approval · Notice of Compliance 22293 · 2019
HEMLIBRA: Notice of Compliance 22293
Issued June 14, 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
- 22293
- Date
- June 14, 2019
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Addition of a new dosing regimen and new indication. hemlibra is indicatied for hemophilia a (congenital factor viii deficiency) patients with or without foactor viii inhibitors as routine prophilaxis to prevent bleeding or reduce the frequency of bleeding episodes
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HEMLIBRA | Not yet assigned | — |
Medicinal ingredients
- EMICIZUMAB 30 MG per ML
- EMICIZUMAB 150 MG per ML
- EMICIZUMAB 60 MG per 0.4ML
- EMICIZUMAB 105 MG per 0.7ML