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[email protected] Website www.ema.europa.eu An agency of the European Union 14/09/2020 EMA/484057/2020 Human Medicines Division Important medical event terms list (MedDRA version 23.1) Primary SOC MedDRA Code PT Name SOC Name Comment Added in 23.1 Change This term fits the inclusion for an immune-mediated condition that is 10084828 Immune-mediated cytopenia Blood and lymphatic system disorders usually related to a drug. Similar PT Immune thrombocytopenia is already X included. In v23.0 this term was an LLT under the PT Bone marrow failure, which 10028584 Myelosuppression Blood and lymphatic system disorders X was included in the 23.0 IME list. This term fits the inclusion criteria as a relevant term for cardiac 10084280 Foetal cardiac arrest Cardiac disorders X arrhythmias. Similar PT Cardiac arrest is included in the IME list. In v23.0 this term was an LLT under the PT Cardiac valve replacement 10080073 Prosthetic cardiac valve stenosis Cardiac disorders X complication, which was included in the 23.0 IME list. Perinatal hepatitis C in pediatric patients may range from asymptomatic to fulminant hepatitis. Congenital hepatitis C infection can be associated with 10084252 Congenital hepatitis C infection Congenital, familial and genetic disorders X significant multi-organ damage which meets the criteria for inclusion in the IME list. Congenital viral hepatitis is a viral infection of the baby's liver which occurs when a pregnant woman infected with hepatitis virus passes the virus onto her unborn infant.