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ZINBRYTA to face restrictions on use, following a safety review by EMA showing serious liver damage

Multiple sclerosis (MS) is condition in which the immune system attacks myelin sheath, which may eventually damage the neurons and leave scar tissue, relapsing multiple sclerosis is a type of sclerosis in which there is flare up following remission, which means during the relapsing phase, the symptoms of MS will partially or completely go away. 

daclizumab is a type of Interleukin 2 receptor (IL2R) antagonist which is used in the treatment of MS. (Interleukin is a type of Cytokine which binds with IL2R to generate immune responses, a type cell signalling) daclizumab was administered as an injection under brand ZINBRYTA, which was first approved by FDA on 27th May 2016, however recently the Pharmacovigilance Risk Assessment committee (PRAC), a part of European Medical Agency recommended restrictions on using daclizumab, due to safety issues associated with serious liver damage (as reported in a clinical trial where 1.7 % subjects developed serious liver reaction, a suspected unexpected serious adverse reaction (SUSAR) when administered with daclizumab).

We at Think I are committed to provide robust pharmacovigilance solutions. We use cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event. 

For more details, contact us at +91 9560102587, +91 9810068241 or email us at medical@thinki.in  or simply visit www.thinki.in
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