Approval · Notice of Compliance 36284 · 2025
OMVOH: Notice of Compliance 36284
Issued July 8, 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
- 36284
- Date
- July 8, 2025
- Company
- Eli Lilly Canada IncToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- 1. New formulation 2. New presentations 3. New indication: Omvoh is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, loss of response, or were intolerant to either conventional therapy or a biologic treatment
Products in this notice
Medicinal ingredients
- MIRIKIZUMAB 200 MG per 2ML
- MIRIKIZUMAB 100 MG per 1ML
- MIRIKIZUMAB 100 MG per PEN
- MIRIKIZUMAB 100 MG per SYR
- MIRIKIZUMAB 20 MG per ML