Official announcements
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
Recall
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Veterinary Medicines
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01/08/2024
Recall due to non-compliant manufacture
Recall
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Medicines
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25/07/2024
Recall due to out of specification results for the parameter content
Recall
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Medicines
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12/07/2024
Recall due to particles in solution
Recall
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Medicines
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05/07/2024
Recall due to a possible incorrect closure of the crimp caps