Omvoh (mirikizumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- mirikizumab
- Company
- Eli Lilly Nederland B.V.
- Status
- Authorised
- Therapeutic area
- Colitis, Ulcerative
- CHMP opinion
- Thu 30 Mar 2023
- EU approval
- Fri 26 May 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005122
- ATC
- L04AC
- Official record
- www.ema.europa.eu
Indication
Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.