Rystiggo (rozanolixizumab)
OrphanAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- rozanolixizumab
- Company
- UCB Pharma
- Status
- Authorised
- Therapeutic area
- Myasthenia Gravis
- CHMP opinion
- Thu 09 Nov 2023
- EU approval
- Fri 05 Jan 2024
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005824
- ATC
- L04AL02
- Official record
- www.ema.europa.eu
Indication
Rystiggo is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
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.