Up-to-date information from the April 19.04.-22.04.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the March 21.03-24.03.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to incorrect expiry date

Recall of one batch due to incorrect patient information leaflet

With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.

The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from 28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products shall be submitted to the competent authority of the Member State in which the clinical trial is to be conducted.

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 a pathogenic variant in the PHA gene has been identified in donor 8458-IDOR and that he is a carrier of PKU (phenylketonuria).

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2022/2023 (published 29 March 2022).

Following reports of adverse effects in animals, BASG draws attention to the fact that precautions should be taken to avoid contact of pets with hormone-containing drugs used on the skin of humans.

Recall due to nitrosamine contamination above the permitted daily dose