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 due to reduced release of active pharmaceutical ingredient

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 due to possible non-sterility

Recall due to possible non-sterility

As part of the implementation of the ISO IDMP requirements in combination with the EU IG, it will be possible to enter marketing information per pack line from 06.12.2023.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Italy, in addition to the provinces already announced, ID WNV NAT testing for donations of blood and blood components has been introduced in Pisa.

Recall due to possible foreign body contamination

Recall due to difficult removability of the tablets from the blister

With the entry into force of Regulation (EU) 2019/6, medicinal products for certain pet animals, which were previously not subject to a marketing authorization requirement under Section 7(4) of the AMG, may now only be marketed in Germany if they have been notified to the BASG.