Sylvant (siltuximab)
Accelerated assessmentAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- siltuximab
- Company
- Recordati Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Giant Lymph Node Hyperplasia
- CHMP opinion
- Thu 20 Mar 2014
- EU approval
- Thu 22 May 2014
- Designations
- Accelerated assessment, Additional monitoring
- Application
- EMEA/H/C/003708
- ATC
- L04AC11
- Official record
- www.ema.europa.eu
Indication
Sylvant is indicated for the treatment of adult patients with multicentric Castleman’s disease (MCD who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
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.