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 (BASG) warns against a potential Contamination of non-sterile ultrasound gel „AquaUltra Clear“ of the manufacturer Ultragel Medical Kft. According to the manufacturer the affected LOT has been narrowed down to LOT-Number 2024-4 to 2024-10.

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.

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

Recall due to delivery of an incorrect batch in Austria

Up-to-date information from the 14.10.-17.10.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to incorrect information in the patient information leaflet

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

The Federal Office for Safety in Health Care has been informed by the Greek authority that, in addition to the regions already announced, confirmed human WNV infections have been recorded in western Attica in Greece.