Zeposia (ozanimod)
- Region
- 🇪🇺 EU
- Active substance
- ozanimod
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting; Colitis, Ulcerative
- CHMP opinion
- Thu 26 Mar 2020
- EU approval
- Wed 20 May 2020
- Application
- EMEA/H/C/004835
- ATC
- L04AA38
- Official record
- www.ema.europa.eu
Indication
Multiple sclerosis Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. Ulcerative colitis Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
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.