Official announcements
Safety warnings
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Blood & Tissue
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24/08/2018
The Federal Office for Safety in Health Care was informed about 6 confirmed autochthonous WNV cases (encephalitis/fever) in the area of Vienna and Lower Austria.
Safety warnings
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Blood & Tissue
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22/08/2018
The Federal Office for Public Health Safety was informed by the Croatian authority that three human autochthonous WNV infections were confirmed in the regions of East Osijek-Baranja and Karlovac.
Recall
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Medicines
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16/08/2018
The marketing authorization holder informed its supplied customers in a letter dated August 16, 2018, that due to quality problems with one batch of ampoules, batch D1K13 is being recalled as a precautionary measure.
Recall
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Medicines
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14/08/2018
The marketing authorization holder informed its supplied customers in a letter dated July 5, 2018, that a production-related impurity occurred at the active ingredient manufacturer during a synthesis step. This impurity is N-nitrosodimethylamine…
Safety warnings
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Blood & Tissue
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14/08/2018
The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank Cryos International (DK257551) of a termination of a pregnancy at 16 weeks' gestation due to abnormalities of the fetus in all four limbs.
The report describes the clinical picture arthrogryposis multiplex congenita (AMC).
Safety warnings
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Blood & Tissue
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13/08/2018
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 Giurgiu, Satu Mare and Iasi.
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.