Up-to-date information from the 17.05.-20.05.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

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 the sperm donations of the donor ALMAR are associated with the diagnosis of ADHD (Attention Deficit Hyperactivity Disorder) in three children.

The Federal Office for Safety in Health Care has received an update from the European Commission regarding suspected adverse reactions to COVID-19 vaccine and the safety of SoHO.

On May 28, 2021, the use "for active immunization of individuals 12 years of age and older" was extended by the EMA.

Recall of one affected batch of Vistabel because there is a risk of incorrect dilution and administration of double dose.

As of 22.5.2021, the function "Withdrawal according to §23 AMG" will be available in the area "Overview Medicinal Products".

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 the sperm donor 26092-SIRIUS is a healthy heterozygous carrier of Deafness-Infertility-Syndrome (DIS).

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 the sperm donor 28113 ROCCO is a healthy carrier of the chronic disease cystic fibrosis (heterozygous for the mutation in the CFTR gene).

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 there has been an occurrence of isovaleric acidemia in a child in connection with the donation of the sperm donor 25079 TEKIN.

The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2021/2022 (published 30 March 2021)