The Federal Office for Safety in Health Care (BASG) has been informed that "LOGIMED Medizinische Spezialprodukte Gesellschaft m.b.H., Gösserstraße 11, 8700 Leoben" (Logimed), which was liquidated in 2011, has no legal successor who continues to fulfil the manufacturer obligations arising from the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, as amended. These obligations include Post Market Surveilance System (PMS), which includes the investigation of incidents and, where appropriate, the initiation of safety corrective actions in the field.

The Federal Office for Safety in Health Care was informed by the Slovenian authority that the first human autochthonous WNV infection was confirmed in the Osrednjeslovenska region.

The Federal Office for Public Health Safety has been informed by the French authority that further confirmed human autochthonous WNV infections have occurred in the areas of the Alpes- Maritimes department.

The Federal Office for Public Health Safety was informed by the Romanian authority that in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the regions of Constanta, Sibiu, Mures, Mehedinti, Tulcea, Calarasi.

The Federal Office for Public Health Safety has been informed by the Italian authority that, in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the regions of Lombardy and Liguria.

The Federal Office for Public Health Safety has been informed by the Croatian authority that in addition to the already known regions, further confirmed human autochthonous WNV infections have occurred in the regions of Zagreb, Zagreb city and Vukovar-Srijem.

The Federal Office for Safety in Health Care was informed about 6 confirmed autochthonous WNV cases (encephalitis/fever) in the area of Vienna and Lower Austria.

The Federal Office for Public Health Safety was informed by the Croatian authority that three human autochthonous WNV infections were confirmed in the regions of East Osijek-Baranja and Karlovac.

The marketing authorization holder informed its supplied customers in a letter dated August 16, 2018, that due to quality problems with one batch of ampoules, batch D1K13 is being recalled as a precautionary measure.

The marketing authorization holder informed its supplied customers in a letter dated July 5, 2018, that a production-related impurity occurred at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…