The parallel distributor - "HAEMATO PHARM GmbH" - informed its supplied customers in a letter dated October 8, 2018, that for the two batches of "Jakavi 15 mg tablets" with the batch numbers SM018 and SAD42, packages were delivered in parallel trade…

The Federal Office for Safety in Health Care was informed about the first confirmed autochthonous WNV case in the Burgenland area.

The Federal Office for Safety in Health Care has been 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 Arges and Vaslui. It is therefore requested that appropriate attention be paid to this in the medical history discussions and donor selections.

The Federal Office for Safety in Health Care has been 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 Alba and Neamt. It is therefore requested that appropriate attention be paid in the medical history discussions and donor selections

The Federal Office for Public Health Safety has been informed by the Italian authority that WNV has been detected in the province of Verbano-Cusio Ossola (Piedmont region) during active surveillance of target bird species. For this reason, testing for donors of blood and blood components (in addition to the regions already notified) will be performed in this region ID WNV NAT.

Information is provided on the possibility of prolonged usability of certain batches of "EpiPen 300 microgram solution for injection in a ready-to-use pen" beyond the expiry date. The batches can be found in the following information letter:

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 Cara Severin, Valcea, Hunedoara, Suceava, Bihor, Cluj, Prahova, Dambovita, Buzau.

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.