Human medicines European public assessment report (EPAR): Sylvant, siltuximab, Date of authorisation: 22/05/2014, Revision: 15, Status: Authorised

Sylvant RSS Authorised This medicine is authorised for use in the European Union siltuximab Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Sylvant is a medicine that is used to treat multicentric Castleman’s disease in adults who are not infected with human immunodeficiency virus (HIV) and human herpesvirus-8 (HHV-8). Castleman’s disease is a disorder of the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream) in which cells in lymph nodes start growing abnormally, causing benign tumours. Multicentric means that the disease affects several lymph nodes as well as other organs in the body. Symptoms can include tiredness, sweating at night, fever, peripheral neuropathy (pins and needles due to nerve damage) and swelling of liver and spleen. Castleman’s disease is rare, and Sylvant was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 November 2007. Sylvant contains the active substance siltuximab. Expand section Collapse section How is Sylvant used? Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision. It is given by infusion (drip) into a vein. The recommended dose is 11 mg per kilogram body weight, and the infusion should last around one hour. Sylvant is given every three weeks, until the patient no longer benefits from treatment. During the first 12 months of treatment the patient should have a blood test before each dose of Sylvant, and every nine weeks afterwards; treatment may need to be delayed in patients whose blood tests are abnormal or who have certain side effects. For more information about using Sylvant, see the summary of product characteristics or contact a doctor or pharmacist. How does Sylvant work? The active substance in Sylvant, siltuximab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Siltuximab has been designed to attach to a protein in the body called interleukin 6 (IL-6). Patients with Castleman’s disease produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes. By attaching to IL-6, siltuximab blocks its activity and stops abnormal cell growth, thus reducing the size of the lymph nodes and the symptoms of the disease. What benefits of Sylvant have been shown in studies? Sylvant has been investigated in one main study involving 79 adults with multicentric Castleman’s disease who did not have HIV or HHV-8 infection. The effect of the medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the proportion of patients who responded to treatment for at least 18 weeks, as shown by a 50% reduction (‘partial response’) or complete disappearance (‘complete response’) of tumours and symptoms of the disease. Sylvant was more effective than placebo in reducing tumour size and disease symptoms: 17 out of 53 patients who received Sylvant showed a partial response and one showed a complete response, compared with none of the 26 patients who received placebo. This effect was maintained for almost one year. What are the risks associated with Sylvant? The most common side effects with Sylvant (which may affect more than 1 in 5 people) are infections (including upper respiratory tract infections such as those of the throat and nose), itching, rash, joint pain and diarrhoea. The most serious side effect is anaphylactic reaction (a severe allergic reaction). For the full list of side effects and restrictions of Sylvant, see the package leaflet. Why is Sylvant authorised in the EU? The European Medicines Agency decided that Sylvant’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman’s disease, and that this positive effect seems to be maintained over time. The Agency also acknowledged that there is an unmet medical need for these patients. Side effects of Sylvant were considered acceptable but further long-term data are to be collected. What measures are being taken to ensure the safe and effective use of Sylvant? The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety. The company will ensure that healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sylvant have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Sylvant are continuously monitored. Side effects reported with Sylvant are carefully evaluated and any necessary action taken to protect patients. Other information about Sylvant Sylvant received a marketing authorisation valid throughout the EU on 22 May 2014. Sylvant : EPAR - Summary for the public Reference Number: EMA/179733/2014 English (EN) (109.24 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View Other languages (22) български (BG) (105.39 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View español (ES) (77.33 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View čeština (CS) (102.65 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View dansk (DA) (75.55 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View Deutsch (DE) (78.32 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View eesti keel (ET) (69.02 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View ελληνικά (EL) (106.01 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View français (FR) (78.01 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View hrvatski (HR) (97.26 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View italiano (IT) (76.33 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View latviešu valoda (LV) (99.68 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View lietuvių kalba (LT) (100.71 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View magyar (HU) (96.36 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View Malti (MT) (103.53 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View Nederlands (NL) (76.64 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View polski (PL) (102.44 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View português (PT) (77.41 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View română (RO) (94.23 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View slovenčina (SK) (102.13 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View slovenščina (SL) (96.32 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View Suomi (FI) (75.66 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View svenska (SV) (76.09 KB - PDF) First published: 19/06/2014 Last updated: 13/07/2018 View Sylvant : EPAR - Risk-management-plan summary English (EN) (71.17 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Product information Sylvant : EPAR - Product information English (EN) (455.74 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View Other languages (24) български (BG) (528.81 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View español (ES) (405.03 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View čeština (CS) (498.94 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View dansk (DA) (409.61 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View Deutsch (DE) (429.5 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View eesti keel (ET) (500.34 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View ελληνικά (EL) (496.33 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View français (FR) (445.91 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View hrvatski (HR) (504.28 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View íslenska (IS) (407.14 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View italiano (IT) (411.61 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View latviešu valoda (LV) (495.52 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View lietuvių kalba (LT) (532.34 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View magyar (HU) (520.88 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View Malti (MT) (549.04 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View Nederlands (NL) (439.23 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View norsk (NO) (420.5 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View polski (PL) (526.42 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View português (PT) (409.76 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View română (RO) (499.51 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View slovenčina (SK) (532.04 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View slovenščina (SL) (517.43 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View Suomi (FI) (504.81 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View svenska (SV) (417.97 KB - PDF) First published: 19/06/2014 Last updated: 24/03/2026 View Latest procedure affecting product information: VR/0000337997 24/03/2026 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Sylvant : EPAR - All Authorised presentations English (EN) (16.72 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Other languages (24) български (BG) (43.29 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View español (ES) (21.65 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View čeština (CS) (36.9 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View dansk (DA) (18.9 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Deutsch (DE) (17.3 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View eesti keel (ET) (17.08 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View ελληνικά (EL) (36.43 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View français (FR) (16.99 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View hrvatski (HR) (30.58 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View íslenska (IS) (19.3 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View italiano (IT) (21.75 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View latviešu valoda (LV) (41.01 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View lietuvių kalba (LT) (35.28 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View magyar (HU) (23.3 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Malti (MT) (34.57 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Nederlands (NL) (21.6 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View norsk (NO) (18.88 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View polski (PL) (35.96 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View português (PT) (18.91 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View română (RO) (33.72 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View slovenčina (SK) (31.72 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View slovenščina (SL) (22.97 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Suomi (FI) (17.6 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View svenska (SV) (17.64 KB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View Product details Name of medicine Sylvant Active substance siltuximab International non-proprietary name (INN) or common name siltuximab Therapeutic area (MeSH) Giant Lymph Node Hyperplasia Anatomical therapeutic chemical (ATC) code L04AC11 Pharmacotherapeutic group Immunosuppressants Therapeutic 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. Authorisation details EMA product number EMEA/H/C/003708 Accelerated assessment This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment . Additional monitoring This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring . Marketing authorisation holder Recordati Netherlands B.V. Recordati Netherlands B.V. Beechavenue 54 1119PW Schiphol-Rijk NETHERLANDS Opinion adopted 20/03/2014 Marketing authorisation issued 22/05/2014 Revision 15 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Sylvant : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (159.85 KB - PDF) First published: 24/10/2025 Last updated: 24/03/2026 View Sylvant : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (824.34 KB - PDF) First published: 14/08/2014 Last updated: 24/10/2025 View Initial marketing authorisation documents Sylvant : EPAR - Public assessment report Adopted Reference Number: EMA/CHMP/258608/2014 English (EN) (2.01 MB - PDF) First published: 19/06/2014 Last updated: 19/06/2014 View CHMP summary of positive opinion for Sylvant Adopted Reference Number: EMA/CHMP/142794/2014 English (EN) (61.79 KB - PDF) First published: 21/03/2014 Last updated: 21/03/2014 View News on Sylvant European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014 10/07/2014 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014 21/03/2014 European Medicines Agency recommends authorisation of first medicine for Castleman's disease 21/03/2014 More information on Sylvant This product is no longer an orphan medicine. It was originally designated an orphan medicine on 30 November 2007. Sylvant was withdrawn from the Community register of orphan medicinal products in May 2024 at the end of the 10-year period of market exclusivity. Topics Medicines This page was last updated on 24/03/2026 Share this page