The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a human dengue case has occurred in France, in the Var region.

Recall of one batch due to a deviation during stability monitoring analysis.

The registry lists in a new form - with search and filter options - those SARS-CoV-2 rapid antigen tests that can be placed on the Austrian market for self-testing.

Recall due to a possible exceedance of the permitted exposure levels for a derivative of the active substance.

Up-to-date information from the 21.06.-24.06.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

The Federal Office for Safety in Health Care has been informed by the Italian authority that a human WNV case has occurred in the province of La Spezia (Liguria Region). ID WNV NAT testing for donations of blood and blood components has been introduced.

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

With this letter, the Federal Office for Safety in Health Care (BASG) draws attention to a possible risk from devices manufactured by Respironics, Inc. (Philips Respironics). The medical devices concerned are ventilators.

Decrease in plasma donations with simultaneous increase in demand for immunoglobulins.

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 three children have contracted distal arthrogryposis (DA) in connection with the use of semen from sperm donor 8466-BENT.