The Federal Office for Safety in Health Care was informed by the Romanian authority that a humane WNV case (confirmed meningitis/encephalitis) was recorded in the county Constanța.

Seven batches of "Neo Citran - Pulver für Erwachsene" contain package leaflets with incorrect information for pregnancy and breast-feeding.

The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Bologna, Modena, Ferrara, Reggio Emilia, Parma (Emilia-Romagna region) and in the province of Bergamo (Lombardy region), due to the detection of WNV NAT positive mosquito pools, ID WNV NAT testing was introduced for donations of blood and blood components.

Precautionary recall because the efficacy of two batches of Binocrit may be reduced.

The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Milan and Pavia (Lombardy Region), due to the detection of WNV NAT positive mosquito pools, the ID WNV NAT testing for donations of blood and blood components was introduced.

We have published updated versions for human accessible Package Leaflets and the QRD template!

The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Lodi, Mantova, Brescia (Region of Lombardy) and in the province of Piacenza (Region of Emilia-Romagna), due to the detection of WNV NAT positive mosquito pools, the ID WNV NAT testing was introduced for donations of blood and blood components.

Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.

Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.

The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.