The Federal Office for Safety in Health Care (BASG) warns of a potential contamination of the non-sterile ultrasound gel “AquaUltra Clear” from the manufacturer Ultragel Medical Kft. According to the manufacturer, the affected batches can be identified by the LOT numbers 2024-04 to 2024-10.

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 the sperm donor 8558/Edward has been diagnosed with type 2 diabetes (DM2). The donor/gametes have been permanently blocked.

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 an offspring of the sperm donor 28203/INGO has been diagnosed with Joubert syndrome. The child shows a Dandy Walker malformation. The donor/gametes have been permanently blocked.

Up-to-date information from the 11.11.-14.11.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

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 Dahme-Spreewald in Germany.

The Federal Office for Safety in Health Care has been informed by the Greek authorities that in Greece, in addition to the regions already announced, a confirmed human WNV infection has been recorded in Zografos.

The BASG reminds marketing authorization holders/registration holders that submissions by a third party (e.g. a consultant) are only valid with the appropriate authorization.

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 Turkey in Antalya, Hatay, Kırklareli and Muğla, in addition to the regions already announced.

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

Recall due to visible particles