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 province of Modena.

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.

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Center 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 departments of Gard, Drôme, Bouches-du-Rhône and Corse-du-Sud.

Recall due to incorrect labelling

Recall due to a mix-up with another product

Recall due to nitrosamine contamination above the permitted daily dose

Recall of the pharmaceutical samples of the mentioned batches due to exceeding the remaining shelf life

The products of the manufacturer "Allergan Aesthetics", a company of AbbVie, are facial fillers that are used in aesthetic medicine to treat wrinkles and to change the appearance of the face.

Recall of due to reduced efficacy