On 31 October 2006, orphan designation (EU/3/06/408) was granted
by the European Commission to Biotest Pharma GmbH, Germany, for
human cytomegalovirus immunoglobulin for the prevention of
congenital cytomegalovirus infection following primary
cytomegalovirus infection in pregnant women. - What is
congenital cytomegalovirus infection following primary
cytomegalovirus infection? Cytomegalovirus is a virus that
infects many people worldwide. In the majority of cases the
virus is latent (inactive) and causes neither disease nor any
symptoms of any kind in man. Usually, the virus is only
activated in patients who, for some reason, have a weaker immune
system. Cytomegalovirus disease can affect several organs in the
body, such as the eyes, liver, lungs and the gastrointestinal
tract (the stomach and intestines) and cause organ failure. If a
woman is infected (primary infection) with cytomegalovirus while
pregnant, the virus can pass to the unborn baby who does not yet
have a very strong immune system. When congenit