Official announcements
Safety warnings
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Blood & Tissue
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09/08/2018
The Federal Office for Public Health Safety has been informed by the Italian authority that 52 human cases of WNV infection have been confirmed in the regions of Veneto and Emilia-Romagna.
Entomological and veterinary surveillance confirmed the circulation of WNV in the affected regions and additionally in the regions of Lombardy and Piedmont.
Safety warnings
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Blood & Tissue
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07/08/2018
The Federal Office for Public Health Safety has been informed by the Romanian authority that, in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the regions of Galati, Teleorman and Vrancea.
Safety warnings
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Blood & Tissue
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06/08/2018
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.
Safety warnings
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Blood & Tissue
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06/08/2018
The Federal Office for Public Health Safety has been informed by the Romanian authorities that, in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the regions of Bacau, Bucuresti, Ilfov and Botosani.
Safety warnings
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messages in brief
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03/08/2018
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan medicines containing the impurity NDMA. NDMA is an impurity found in the active ingredient valsartan,…
Safety warnings
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Medicines
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03/08/2018
Preliminary risk assessment of NDMA for patients
messages in brief
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30/07/2018
New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website ( http://esubmission.ema.europa.eu/eaf/ ). Specific information from the BASG are published on…
Safety warnings
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Blood & Tissue
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25/07/2018
The Federal Office for Public Health Safety has been informed by the Romanian authority that, in addition to the regions already announced, three confirmed human WNV (meningitis/encephalitis) infections have occurred in the regions of Dolj and Lasi.
Recall
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Veterinary Medicines
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24/07/2018
Richter Pharma AG" as distributor of the veterinary medicinal product "Doxapram-V", which is approved in Germany, has informed its customers that batch 0617569AA is being recalled by the marketing authorization holder "Albrecht GmbH". The reason is a…
Safety warnings
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Blood & Tissue
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23/07/2018
The Federal Office for Safety in Health Care was informed by the Hungarian authority that two confirmed human WNV infections occurred in Perkata (Fejèr County) and in Balatonfüred (Veszprèm County).