Official announcements
CHMP Monthly News
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06/05/2024
Up-to-date information from the 22.04.-25.04.2024 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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26/04/2024
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 a "non-classical adrenogenital syndrome" had been reported in an offspring of the sperm donor 8845 BERRY.
Safety warnings
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Blood & Tissue
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26/04/2024
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 one offspring of donor 25639-TESSER has been diagnosed with 22q11 duplication syndrome.
Safety warnings
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Medicines
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12/04/2024
Precautionary batch recall as a glass splinter was discovered in a 60 ml bottle.
Recall
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Medicines
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12/04/2024
Recall due to possible contamination with glass splinters
CHMP Monthly News
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09/04/2024
Up-to-date information from the 27.03.-30.03.2024 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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09/04/2024
Recall due to appearance of the solution
Recall
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Medicines
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05/04/2024
Recall due to a possible incorrect closure of the crimp caps
Enforcement
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05/04/2024
Das BASG warns against the product "Prostapax Forte", because it is categorised as an illegal medicinal product (medicinal product by presentation) due to its claims in the advertising brochure.