Official announcements
Safety warnings
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Blood & Tissue
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16/08/2016
The Federal Office for Safety in Health Care was informed by the Italian authority that two blood donors in the provinces of Mantova and Cremona (Lombardia Region) tested positive for WNV NAT. Furthermore, four symptomatic human WNV cases (two of which were neuroinvasive) were reported in the provinces of Verona, Rovigo (Veneto Region), and Reggio Emilia (Emilia Romagna Region).
Recall
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Medicines
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11/08/2016
The marketing authorization holder informed its supplied customers in a letter dated August 10, 2016, that the above-mentioned batches of Kogenate®Bayer are being recalled. Stability data for these batches indicated a faster than usual decline in…
Safety warnings
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Blood & Tissue
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10/08/2016
The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Padova (Veneto Region) in addition to the regions already announced.
Recall
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Medicines
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10/08/2016
CSL Behring as distributor of the product Helixate®NexGen has, in coordination with the marketing authorization holder Bayer Pharma AG, informed its supplied customers by letter dated August 8, 2016, that above mentioned batches of Helixate®NexGen…
Safety warnings
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Blood & Tissue
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09/08/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the province of Forli-Cesena (Emilia-Romagna Region) in addition to the regions already announced.
Safety warnings
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Blood & Tissue
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05/08/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the provinces of Torino (Piedmont Region), Monza-Brianza (Lombardia Region), and Veneto (Veneto Region) in addition to the regions already announced.
Recall
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Medicines
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05/08/2016
The marketing authorization holder has informed its supplied customers in a letter dated August 4, 2016, that after the application of "Nutriflex Lipid special Emulsion for Infusion " of the batch 160338052 individual cases of fever and chills have…
Safety warnings
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Blood & Tissue
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03/08/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that WNV NAT testing will now be carried out in the provinces of Parma (Emilia-Romagna Region) and Cremona (Lombardia Region) in addition to the regions already announced.
Recall
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Veterinary Medicines
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02/08/2016
The distribution company "Chevita Tierarzneimittel Ges.m.b.H." has informed its supplied customers with 05.07.2016 that in the course of stability tests a reduced content of active ingredient was found and therefore the affected packages of this drug…
Safety warnings
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Blood & Tissue
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26/07/2016
The Federal Office for Public Health Safety has been informed by the Italian authority that the first human WNV (neuro-invasive disease) infection has been recorded in the province of Bologna (Emilia-Romagna Region).