Recall due to possible microbial contamination

Recall due to possible microbial contamination

Publication of a joint declaration by the competent national EU authorities to the EU Commission.

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 Cryos International - Aarhus ApS that the donor BLICHER has been diagnosed with ADHD. As there is a slightly increased risk (1-12%) of ADHD in donor conceived children, the donor gametes are blocked.

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