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 (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous cases of chikungunya have been recorded in the overseas department of La Réunion (Saint Denis).

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.

Up-to-date information from the 27.01.-30.01.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish Born Donor Bank (DK261306) that an offspring of the sperm donor Peters was born with a congenital structural heart defect (muscular ventricular septal defect and atrial septal defect). The donor/gametes were 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 European Sperm Bank (DK257572) that the sperm donor 8324/Iners is a carrier of carnitine palmitoyltransferase 2 (CPT2) deficiency due to a mutation in the CPT2 gene. The donor/the donor gametes were permanently blocked.

The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that 4 confirmed autochthonous dengue cases have been recorded in the overseas department of La Réunion.

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

Recall due to unregistered serial numbers