Uplizna (inebilizumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- inebilizumab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Neuromyelitis Optica
- CHMP opinion
- Thu 11 Nov 2021
- EU approval
- Mon 25 Apr 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005818
- ATC
- L04AA
- Official record
- www.ema.europa.eu
Indication
Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).
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.