Approval · Notice of Compliance 34981 · 2025
HEMLIBRA: Notice of Compliance 34981
Issued March 6, 2025
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
- 34981
- Date
- March 6, 2025
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New fill volume. Change in manufacturing process
Products in this notice
Medicinal ingredients
- EMICIZUMAB 30 MG per ML
- EMICIZUMAB 150 MG per ML
- EMICIZUMAB 60 MG per 0.4ML
- EMICIZUMAB 105 MG per 0.7ML