Official announcements
Safety warnings
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Blood & Tissue
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04/08/2025
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the
Danish tissue bank European Sperm Bank (DK257572) that one of the offspring of the sperm donor 25658/Haydar was diagnosed with spinal muscular atrophy (SMA) type 1 during newborn screening.
The donor/the donor gametes have been permanently blocked.
Safety warnings
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Blood & Tissue
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04/08/2025
The Federal Office for Safety in Health Care has been informed that confirmed human WNV infections have been recorded in Bulgaria in the following region:
Sofia
For further information, please refer to the following safety warnings. We kindly ask you to pay attention to this during anamnesis interviews and donor selections.
Safety warnings
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Medical devices
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31/07/2025
There is a potential health risk, as the safety and efficacy of the counterfeit products are not guaranteed. The contents of the counterfeit products are unknown.
Recall
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Medicines
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30/07/2025
Recall due to impurities
Safety warnings
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Medical devices
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28/07/2025
The Federal Office for Safety in Health Care (BASG) has been informed about the counterfeit product "NovoFine Plus 32G 4mm" with the batch number NE61324-2 from the manufacturer Novo Nordisk A/S.
Safety warnings
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Medical devices
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28/07/2025
The Federal Office for Safety in Health Care (BASG) has been informed that the following products have been counterfeited:
- Unbreakable by TCS
- IFlex by TCS
- Karadent by TCS
CHMP Monthly News
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24/07/2025
Up-to-date information from the 16.06.-19.06.2025 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Safety warnings
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Medical devices
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18/07/2025
The Federal Office for Safety in Health Care (BASG) warns against the disinfection system with peroxide 3 % from the manufacturer DISOP S.A. Only certain batch numbers are affected.