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)

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

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 geleophysical dysplasia in a child in connection with the donation of the sperm donor 25009-POULI. The donor is a carrier of the autosomal recessive disease geleophysical dysplasia, GD.