The marketing authorization holder has informed its supplied customers in a letter dated 22.11.2017 that deviations from the microbial limit values were detected in a batch marketed abroad. As a precautionary measure, all batches that were produced…

The marketing authorization holder informed its supplied customers in a letter dated November 8, 2017, that a production-related crack at the valve connection seal to the bag may occur in "Physioneal Clear-Flex bags". On the one hand, the crack could…

As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good…

The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Nordic Cryobank ApS - NCB - (European Sperm Bank) about a microduplication in the PAR1 regionXp22.33/Yp11.32 in sperm donor 8040/ADLER. The duplication was verified by multiplex ligation-dependent probe amplification(MLPA; probemix P018-G1 SHOX, MRC-Holland). The duplication does not involve the SHOX gene but is located downstream in the regulatory region.

The Federal Office for Public Health Safety has been informed by the French authority that the first human WNV infection has been confirmed in Nice. Therefore, the French authority extends the seasonal WNV surveillance until November 15, 2017.

Italy is currently experiencing four clusters of autochthonous chikungunya cases in the cities of Anzio, Latina and Rome in the Lazio region, and the city of Guardavalle Marina in the Calabria region. Autochthonous transmission of mosquito-borne infections is not unexpected in areas where Aedes albopictus mosquitoes are established and at a time when environmental conditions are favouring mosquito abundance and activity.

The Federal Office for Public Health Safety has been informed by the Romanian authorities that two new human WNV (meningitis/meningoencephalitits) infections have been confirmed in the capital city of Bucharest.

The Federal Office for Public Health Safety has been informed by the Italian authority that four confirmed cases of malaria have been recorded in non-EU citizens in Italy (Apulia Region: Ginosa, Taranto Province).

In a letter dated September 27, 2017, the marketing authorization holder informed its customers that an incorrect expiration date was printed on batch 7103 of "Coldan Nasal Spray". The expiration date was printed incorrectly as "2022-06" (June 2022),…

The Federal Office for Public Health Safety has been informed by the Italian authority that two more confirmed autochthonous chikungunya cases have been recorded. The reports themselves come from Rome - Lazio Region and Reggio Emilia - Emilia Romagna Region.