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.

Up-to-date information from the 17.05.-20.05.2021 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 Danish authority that it has been informed by the Danish tissue bank Cryos International (DK257551) that the sperm donations of the donor ALMAR are associated with the diagnosis of ADHD (Attention Deficit Hyperactivity Disorder) in three children.

The Federal Office for Safety in Health Care has received an update from the European Commission regarding suspected adverse reactions to COVID-19 vaccine and the safety of SoHO.