Briumvi (ublituximab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ublituximab
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
- CHMP opinion
- Tue 30 May 2023
- EU approval
- Wed 31 May 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005914
- ATC
- L04
- Official record
- www.ema.europa.eu
Indication
Briumvi is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
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.