Recall due to powder in the blister pouches

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

Recall due to incorrectly sealed blister packs

The Federal Office for Safety in Health Care was informed by the Romanian authorities that, following intrauterine insemination and subsequent prenatal genetic testing, trisomy 18 was suspected, which was later confirmed by a chorionic villus sampling (CGH array). There was also a suspicion of a complex heart malformation.

Paracetamol preparations can continue to be used during pregnancy in accordance with the official recommendations.

Recall due to failure to meet water quality requirements

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

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in Kosovo, in Peja.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in Çanakkale, Turkey.

The Federal Office for Safety in Health Care (BASG) has been informed by the Italian authorities that confirmed autochthonous Dengue cases have been recorded in Italy, in Brendola (Province of Vicenza).