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

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

To better monitor and, if necessary, counteract supply shortages of medicinal products at EU level, the European Shortages Monitoring Platform (ESMP) was established by the EMA in accordance with the Regulation (EU) 2022/123. The full version of the platform was launched in January 2025.

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 2 offspring of the sperm donor 8860 RUMLE have been diagnosed with DiGeorge syndrome (22q11 deletion syndrome). The donor/gametes were permanently blocked.