What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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PHELINUN 200 mg Pulver und Lösungsmittel für ein Konzentrat zur Herstellung einer Infusionslösung New
Recall
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Medicines
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22/12/2025
Recall due to incorrect labelling of active substance content
Safety warnings
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Blood & Tissue
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22/12/2025
The Federal Office for Safety in Health Care (BASG) has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, further confirmed autochthonous cases of chikungunya have been recorded in Landes, France.
Recall
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Veterinary Medicines
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19/12/2025
Recall due to particles in the solvent
Levonorgestrel intra-uterine devices New
PSUFU
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19/12/2025
Further information is available on the HMA-Website.
Estradiol (except cream/balm/emulsion for application in female genital area) New
Additional template
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19/12/2025
Correction of wording to be implemented following PSUSA on estradiol (except cream/balm/emulsion for application in female genital area) (PSUSA/00010440/202108). Further information can be found in the CMDh minutes from november 2025.
Recall
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Medicines
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18/12/2025
Recall due to impurities and low viscosity
Safety warnings
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Medical devices
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18/12/2025
The Federal Office for Safety in Health Care (BASG) warns of non-conforming subcutaneous and absorbable PDO threads, marketed as “ARIEL PDO Threads”, along with associated cannulas intended for mechanical tightening of loose and sagging skin (facelifting).
18/12/2025
What is this guide? New More and more people are being treated with products made from human cells or tissue. These may be used directly or may have been technically processed beforehand. Today, such
Safety warnings
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Blood & Tissue
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18/12/2025
The donor/the donor gametes have been permanently blocked.
18/12/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass die dänischen Gewebebank European Sperm Bank ApS folgende Information übermittelt hat:
Der Samenspender 45047/Geoffrey ist Träger der alpha-Thalassämie.
Der Spender/die Spendergameten wurden permanent gesperrt.
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