Official announcements
Recall
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Medicines
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18/08/2023
Recall due to possible particles
Recall
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Medicines
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17/08/2023
Recall due to slightly increased peroxide number
Safety warnings
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Blood & Tissue
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10/08/2023
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 that a one-year-old male offspring of the donor had been diagnosed with infantile cystinosis.
Safety warnings
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Blood & Tissue
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09/08/2023
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 (DK257551) that a 16p13.11 duplication was detected during prenatal screening of a donor-conceived fetus.
Safety warnings
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Blood & Tissue
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08/08/2023
The Federal Office for Safety in Health Care has been informed by the French authority that measurement deviations have occurred with the medical device for whole blood collection TAT (top and top) FQE614B (equipped with an LXT leukocyte reduction filter) from the medical device manufacturer Macopharma.
Safety warnings
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Blood & Tissue
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07/08/2023
The Federal Office for Public Health Safety has been notified by the ECDC (European Centre for Disease Prevention and Control) that confirmed human WNV infections have been recorded in the following non-EU countries:
Albania, Kosovo, Montenegro, Northern Macedonia, Serbia, and Turkey.
Safety warnings
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Blood & Tissue
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04/08/2023
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 a hearing impairment has occurred in an offspring of donor-25006 ARNI, suggesting a possible genetic background.
Recall
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Medicines
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02/08/2023
Recall due to possible contamination with midazolam
CHMP Monthly News
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01/08/2023
Up-to-date information from the 17.07.-20.07.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Safety warnings
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messages in brief
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01/08/2023
10 years after the review of iron-containing drugs for intravenous use associated with allergic reactions, cautions are recalled.