Official announcements
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.
Recall
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Medicines
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17/07/2025
Recall due to possible microbial contamination
Recall
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Medicines
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16/07/2025
Recall due to possible microbial contamination
messages in brief
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14/07/2025
Publication of a joint declaration by the competent national EU authorities to the EU Commission.
Safety warnings
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Blood & Tissue
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10/07/2025
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 Cryos International - Aarhus ApS that the donor BLICHER has been diagnosed with ADHD. As there is a slightly increased risk (1-12%) of ADHD in donor conceived children, the donor gametes are blocked.