Official announcements
Recall
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Veterinary Medicines
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11/10/2018
The marketing authorization holder has informed its supplied customers by letter dated 09/10/2018 that an atypical trend in the level of non-specified impurities has been detected in terbinafine - one of the three active ingredients in Osurnia.…
Recall
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Medicines
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11/10/2018
The marketing authorization holder informed the supplied customers via its distribution partner in a letter dated 01.10.2018 that the urology catheters of the company ConvaTec may exhibit unsterility. In tests conducted with the packaging of the…
Safety warnings
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Blood & Tissue
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11/10/2018
The Federal Office for Public Health Safety has been notified by the French authority that a human autochthonous case of dengue virus infection has occurred in the Hèrault region.
Safety warnings
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Blood & Tissue
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09/10/2018
The Federal Office for Public Health Safety has been informed by the French authorities that, in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the regions of Vaucluse, Bouches-du-Rhône, Var, Corsica and Monaco.
Safety warnings
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Blood & Tissue
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09/10/2018
The Federal Office for Public Health Safety has been notified by the French authority that a human autochthonous case of dengue virus infection has occurred in the Alpes-Maritimes region.
Recall
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Medicines
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08/10/2018
The parallel distributor - "HAEMATO PHARM GmbH" - informed its supplied customers in a letter dated October 8, 2018, that for the two batches of "Jakavi 15 mg tablets" with the batch numbers SM018 and SAD42, packages were delivered in parallel trade…
Safety warnings
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Blood & Tissue
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01/10/2018
The Federal Office for Safety in Health Care was informed about the first confirmed autochthonous WNV case in the Burgenland area.
Safety warnings
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Blood & Tissue
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27/09/2018
The Federal Office for Safety in Health Care 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 Arges and Vaslui.
It is therefore requested that appropriate attention be paid to this in the medical history discussions and donor selections.
Safety warnings
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Blood & Tissue
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26/09/2018
The Federal Office for Safety in Health Care 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 Alba and Neamt.
It is therefore requested that appropriate attention be paid in the medical history discussions and donor selections
Safety warnings
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Blood & Tissue
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24/09/2018
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV has been detected in the province of Verbano-Cusio Ossola (Piedmont region) during active surveillance of target bird species.
For this reason, testing for donors of blood and blood components (in addition to the regions already notified) will be performed in this region ID WNV NAT.