Zilbrysq (zilucoplan)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- zilucoplan
- Company
- UCB Pharma S.A.
- Status
- Authorised
- Therapeutic area
- Myasthenia Gravis
- CHMP opinion
- Thu 14 Sep 2023
- EU approval
- Fri 01 Dec 2023
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005450
- ATC
- L04AJ06
- Official record
- www.ema.europa.eu
Indication
Zilbrysq 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) 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.