Official announcements
Recall
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Medicines
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22/12/2023
Recall due to incorrect expiration date.
Recall
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Medicines
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20/12/2023
Recall due to inadequate water content
CHMP Monthly News
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20/12/2023
Up-to-date information from the 11.12.-14.12.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Recall
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Medicines
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20/12/2023
Recall due to reduced release of active pharmaceutical ingredient
Safety warnings
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Blood & Tissue
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13/12/2023
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 an offspring of donor 8347 ELIUS has been diagnosed with SCID (severe combined immune deficiency).
Recall
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Medicines
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12/12/2023
Recall due to possible non-sterility
Recall
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Medicines
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06/12/2023
Recall due to possible non-sterility
messages in brief
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05/12/2023
As part of the implementation of the ISO IDMP requirements in combination with the EU IG, it will be possible to enter marketing information per pack line from 06.12.2023.
Safety warnings
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Blood & Tissue
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04/12/2023
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that in Italy, in addition to the provinces already announced, ID WNV NAT testing for donations of blood and blood components has been introduced in Pisa.
Recall
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Medicines
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01/12/2023
Recall due to possible foreign body contamination