Approval · Notice of Compliance 35977 · 2025
OMLYCLO: Notice of Compliance 35977
Issued September 9, 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
- 35977
- Date
- September 9, 2025
- Company
- Celltrion Inc.Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new presentation
Products in this notice
Medicinal ingredients
- OMALIZUMAB 75 MG per 0.5ML
- OMALIZUMAB 150 MG per ML