Official announcements
Safety warnings
|
Blood & Tissue
|
16/01/2024
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 two donor offspring (siblings) of donor 8712 JAYDON have been diagnosed as carriers of a pathogenic variant of COL3A1 and are at risk of developing Ehlers-Danlos syndrome (EDS).
Safety warnings
|
Blood & Tissue
|
16/01/2024
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 COSTA IVA (isovaleric acidemia) has been reported in an offspring of donor 26006.
Recall
|
Medicines
|
05/01/2024
Recall due to glass particles found
Recall
|
Medicines
|
22/12/2023
Recall due to incorrect expiration date.
Recall
|
Medicines
|
20/12/2023
Recall due to inadequate water content
CHMP Monthly News
|
20/12/2023
Up-to-date information from the 11.12.-14.12.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Recall
|
Medicines
|
20/12/2023
Recall due to reduced release of active pharmaceutical ingredient
Safety warnings
|
Blood & Tissue
|
13/12/2023
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 an offspring of donor 8347 ELIUS has been diagnosed with SCID (severe combined immune deficiency).
Recall
|
Medicines
|
12/12/2023
Recall due to possible non-sterility
Recall
|
Medicines
|
06/12/2023
Recall due to possible non-sterility