Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: EUSA Pharma (Netherlands) B.V., Johannes Vermeerplein 11, 1071 DV, Amsterdam, Netherlands
SYLVANT 100 mg powder for concentrate for solution for infusion.
SYLVANT 400 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion (powder for concentrate). The product is a freeze-dried white powder. |
SYLVANT 100 mg powder for concentrate for solution for infusion: Each single-use vial contains 100 mg siltuximab powder for concentrate for solution for infusion.
After reconstitution the solution contains 20 mg siltuximab per mL.
SYLVANT 400 mg powder for concentrate for solution for infusion: Each single-use vial contains 400 mg siltuximab powder for concentrate for solution for infusion.
After reconstitution the solution contains 20 mg siltuximab per mL.
Siltuximab is a chimeric (human-murine) immunoglobulin G1Îș (IgG1Îș) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Siltuximab |
Siltuximab is a monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6. Siltuximab prevents the binding of human IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signaling complex with gp130 on the cell surface. |
| List of Excipients |
|---|
|
Histidine |
SYLVANT 100 mg powder for concentrate for solution for infusion: 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab. Pack size of 1 vial.
SYLVANT 400 mg powder for concentrate for solution for infusion: 30 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of siltuximab. Pack size of 1 vial.
EUSA Pharma (Netherlands) B.V., Johannes Vermeerplein 11, 1071 DV, Amsterdam, Netherlands
SYLVANT 100 mg powder for concentrate for solution for infusion: EU/1/14/928/001
SYLVANT 400 mg powder for concentrate for solution for infusion: EU/1/14/928/002
Date of first authorisation: 22 May 2014
Date of latest renewal: 2 April 2019
| Drug | Countries | |
|---|---|---|
| SYLVANT | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States |
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