Up-to-date information from the 16.09.-19.09.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The Federal Office for Safety in Health Care (BASG) has been informed by the Italian authorities that in Italy, in addition to the provinces already announced, the ID WNV NAT test for donations of blood and blood components has been introduced in Caserta (Campania region).

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

Recall due to possible side effects

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, confirmed human WNV infections have been recorded in Arta, Preveza, Athens Centre and Pieria.

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

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

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

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 Germany in Diepholz, Jena-Kreisfreie Stadt and Meißen.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in the Czech Republic, in the Jihomoravský kraj region.