The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Meissen in Germany.

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

Up-to-date information from the 09.10.-12.10.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a confirmed human WNV infection has been recorded in the Czech Republic, in Ústecký kraj.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that sperm donor 25308 BAO has been diagnosed with muliple sclerosis.

The Federal Office for Safety in Health Care was informed by the ECDC (European Centre for Disease Prevention and Control) that nine autochthonous human dengue virus cases were recorded in Boulbon (Bouches-du-Rhône Département, Region Provence-Alpes-Côte d'Azur) and seven in Gagnières (Gard Département, Region Occitanie). One autochthonous dengue virus case was also recorded in Limeil-Brévannes (Val-de-Marne département, Île-de-France region).

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Greece, in addition to the regions already announced, human WNV infections have been recorded in the regions of Argolida, Arkadia and Achaia.

CHESSMEN Board meets in Rome to discuss shortage prevention.

The Federal Office for Safety in Health Care (BASG) informs about new developments concerning counterfeits of the medicinal product Ozempic® (manufacturer: Novo Nordisk A/S). The existing BASG warnings of 12/10/2023, 19/10/2023 and 23/10/2023 remain valid. The manufacturer's mailing is supplemented with comprehensive patient information.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Hungary, in addition to the regions already announced, confirmed human WNV infections have been recorded in the Békés region.