Official announcements
Safety warnings
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Blood & Tissue
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03/08/2020
The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Bologna, Modena, Ferrara, Reggio Emilia, Parma (Emilia-Romagna region) and in the province of Bergamo (Lombardy region), due to the detection of WNV NAT positive mosquito pools, ID WNV NAT testing was introduced for donations of blood and blood components.
Recall
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Medicines
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29/07/2020
Precautionary recall because the efficacy of two batches of Binocrit may be reduced.
Safety warnings
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Blood & Tissue
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28/07/2020
The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Milan and Pavia (Lombardy Region), due to the detection of WNV NAT positive mosquito pools, the ID WNV NAT testing for donations of blood and blood components was introduced.
messages in brief
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27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
Safety warnings
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Blood & Tissue
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20/07/2020
The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Lodi, Mantova, Brescia (Region of Lombardy) and in the province of Piacenza (Region of Emilia-Romagna), due to the detection of WNV NAT positive mosquito pools, the ID WNV NAT testing was introduced for donations of blood and blood components.
Recall
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Medicines
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13/07/2020
Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.
Recall
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Medicines
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13/07/2020
Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.
messages in brief
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09/07/2020
The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.