Official announcements
Safety warnings
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Blood & Tissue
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04/09/2018
The Federal Office for Public Health Safety has been informed by the French authority that further confirmed human autochthonous WNV infections have occurred in the areas of the Alpes- Maritimes department.
Safety warnings
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Blood & Tissue
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28/08/2018
The Federal Office for Public Health Safety was 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 Constanta, Sibiu, Mures, Mehedinti, Tulcea, Calarasi.
Safety warnings
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Blood & Tissue
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28/08/2018
The Federal Office for Public Health Safety has been informed by the Italian authority that, in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the regions of Lombardy and Liguria.
Safety warnings
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Blood & Tissue
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27/08/2018
The Federal Office for Public Health Safety has been informed by the Croatian authority that in addition to the already known regions, further confirmed human autochthonous WNV infections have occurred in the regions of Zagreb, Zagreb city and Vukovar-Srijem.
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.