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 (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that confirmed autochthonous dengue cases have been recorded in the French overseas territories: Guadeloupe, Martinique, Saint-Martin, Saint-Barthélemy, French Guiana and French Polynesia.

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.

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 dengue cases have been recorded on the Portuguese island of Madeira.

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

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