The Federal Office for Safety in Health Care has been informed by the Greek authorities that confirmed human WNV infections have been recorded in Greece in the Attica region (Western Attica, Piraeus, Attica islands).

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 - Aarhus ApS that the donor BLICHER has been diagnosed with ADHD. As there is a slightly increased risk (1-12%) of ADHD in donor conceived children, the donor gametes are blocked.

The Federal Office for Safety in Health Care (BASG) warns against the disinfection system with peroxide 3 % from the manufacturer DISOP S.A. Only certain batch numbers are affected.

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

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that in France, in addition to the regions already announced, confirmed autochthonous cases of chikungunya have been recorded in the Département Bas-Rhin.

Starting in July 2025, BASG/AGES MEA will provide an Excel export of the packages available in our database for each human medicinal product. This is also intended to support data entries in SPOR-PMS and XEVMPD (Article 57). Detailed information can be found in the following guide (L_Z34).

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

Recall due to incorrect labelling

Recall due to a mix-up with another product

Recall due to nitrosamine contamination above the permitted daily dose