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

Up-to-date information from the 24.02.-27.02.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to possible contamination with glass splinters

Precautionary batch recall, as there may be glass splinters in the 60 ml bottles

Recall due to deviations from the specified values regarding resuspendability

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 one of the offspring of the sperm donor Bjarke has been diagnosed with Usher syndrome. The donor/gametes have been permanently blocked.

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 one of the offspring of the sperm donor Gilmore, Leber has been diagnosed with congenital amaurosis. The donor/gametes were permanently blocked.

Non-compliant advanced therapy medicinal products can pose serious risks to patients.

Recall due to out of specification results for the parameter drying loss

The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 9677 had been diagnosed with Graves' disease (Graves' disease). The donor/gametes have been permanently blocked.