Official announcements
Safety warnings
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Blood & Tissue
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28/06/2022
The Federal Office for Safety in Health Care has been informed by the Danish authority that
the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 8338-REMON has been diagnosed with
sperm donor 8338-REMON has been diagnosed with Bipolar Disorder Type II.
Recall
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Medicines
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27/06/2022
Precautionary recall due to possible contamination
Recall
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Medicines
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13/06/2022
Recall due to nitrosamine contamination above the permitted daily dose.
Recall
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Medicines
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10/06/2022
Precautionary recall due to possible microbial contamination.
Safety warnings
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Blood & Tissue
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07/06/2022
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 in connection with the use of semen from sperm donor 8981-PARMO a child has been diagnosed with: galactosemia.
messages in brief
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24/05/2022
For the new QRD templates Vers. 9 veterinary, which take into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6, updated accessible Word templates are available for download.
Safety warnings
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Blood & Tissue
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24/05/2022
The Federal Office for Public Health Safety would like to draw attention to the current Rapid Risk Assessment of the ECDC (European Centre for Disease Prevention and Control) on monkeypox.
CHMP Monthly News
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18/05/2022
Up-to-date information from the April 19.04.-22.04.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
CHMP Monthly News
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18/05/2022
Up-to-date information from the March 21.03-24.03.2022 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.