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 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 human WNV infections have been recorded in the Czech Republic, in the Jihomoravský kraj region.

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Center for Disease Prevention and Control) that confirmed autochthonous human dengue cases have been recorded in the regions of Catalonia (province of Tarragona) and Murcia, as well as in the province of Cadiz and Ibiza.

Important information from the Federal Office for Safety in Health Care about the known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of Senvelgo 15 mg/ml oral solution for cats (velagliflozin).

The Federal Office for Safety in Health Care was informed about confirmed autochthonous WNV cases in Vienna and the Weinviertel region.

The Federal Office for Safety in Health Care would like to draw your attention to the current assessment of the ECDC (European Center for Disease Prevention and Control) on Mpox.

Up-to-date information from the 22.07.-25.07.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Up-to-date information from the 24.06.-27.06.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.