Up-to-date information from the 08.11.-11.11.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to particles.

Recall due to visible particles in solution for injection.

Representatives of PEI and AGES-MEA again discussed national legal requirements and cooperation on allergens.

The new legal framework for veterinary medicines (Regulation 2019/6 and 2021/16, Article 9(h)) requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022.

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 (DK257551) that Alport syndrome has been confirmed as a dominant heritable genetic cause in the donor BLOB family.

The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a human WNV infection has been reported for the first time in the Burgenlandkreis region in Germany during the current season.

Recall due to particles

Recall of one batch due to presence of ciclosporine cristals.

Up-to-date information from the 11.10.-14.10.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.