What is the EMA?

Mar 6, 2012 ... For these very small children, eculizumab should be considered first. In larger children who can be treated with plasma exchange, treatment with ... Eculizumab blocks the complement pathway. ▫ Humanised version of anti-C5 antibody, binding specifically to the complement protein. C5 (NHS 2012). Eculizumab injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). 600mg weekly for the first 4 weeks, followed by 900mg for the fifth dose 1 week later, then 900mg every 2 weeks thereafter. Jul 14, 2017 ... What is already known about this topic? Eculizumab (Soliris, Alexion Pharmaceuticals), a terminal complement inhibitor, is associated with a ... Why is Soliris authorised in the EU? Soliris was shown to benefit patients with these rare diseases. The safety profile was similar for all the diseases and was ... May 3, 2019 ... In an open-label study involving 14 patients with highly clinically active, AQP4-IgG–positive disease, the use of eculizumab reduced the frequency of relapse. Eculizumab ... Not to be confused with ocrelizumab. Eculizumab, sold under the brand name Soliris among others, is a recombinant humanized monoclonal antibody ... See full prescribing information for. SOLIRIS. SOLIRIS® (eculizumab) injection, for intravenous use. Initial U.S. Approval: 2007. WARNING: SERIOUS MENINGOCOCCAL ... Oct 24, 2017 ... The US Food and Drug Administration (FDA) approved eculizumab as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti- ...