Official announcements
Safety warnings
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Blood & Tissue
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30/09/2024
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in the Czech Republic, in the Jihomoravský kraj region.
Safety warnings
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16/09/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Center for Disease Prevention and Control) that confirmed autochthonous human dengue cases have been recorded in the regions of Catalonia (province of Tarragona) and Murcia, as well as in the province of Cadiz and Ibiza.
Safety warnings
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Veterinary Medicines
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11/09/2024
Important information from the Federal Office for Safety in Health Care about the known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of Senvelgo 15 mg/ml oral solution for cats (velagliflozin).
Safety warnings
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Blood & Tissue
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05/09/2024
The Federal Office for Safety in Health Care was informed about confirmed autochthonous WNV cases in Vienna and the Weinviertel region.
Safety warnings
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Blood & Tissue
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02/09/2024
The Federal Office for Safety in Health Care would like to draw your attention to the current assessment of the ECDC (European Center for Disease Prevention and Control) on Mpox.
CHMP Monthly News
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30/08/2024
Up-to-date information from the 22.07.-25.07.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
CHMP Monthly News
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29/08/2024
Up-to-date information from the 24.06.-27.06.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Safety warnings
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Blood & Tissue
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27/08/2024
The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank (DK257572) that an offspring of the sperm donor 25297/TROHN carries a pathogenic variant of the ATM gene. Genetic testing of the donor identified the ATM variant in a heterozygous state.
The donor/the donor gametes were permanently blocked.
Safety warnings
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Blood & Tissue
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23/08/2024
The Federal Office for Safety in Health Care has been informed by the French authorities that, in addition to the regions already announced, confirmed autochthonous human dengue cases have been recorded in France in the departments of Vaucluse and Var (Côte d`Azur) and in the department of Drome (Rhône des Alpes).
Recall
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Medicines
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21/08/2024
Recall due to possible glass breakage at the neck of the vial