What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Recall
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Medicines
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10/12/2025
Recall due to contamination with petroleum jelly
Recall
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Medicines
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10/12/2025
Recall due to deviations from quality standards at the active ingredient manufacturer
10/12/2025
1225_Register Arzneimittelvermittler.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenz- nummer Betriebsstandort Straße PLZ Ort 484516 AGILIS Trading GmbH Kärntner Str. 26/3 1010 Wien 484493
Referenced at:
Safety warnings
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Blood & Tissue
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10/12/2025
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.
Enforcement
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09/12/2025
Feline infectious peritonitis (FIP) is an infectious disease caused by feline coronavirus and affects exclusively cats. The disease is incurable and usually fatal. Studies are currently investigating the suitability of the active ingredient GS-441524 for the treatment of FIP. However, there is presently no corresponding approved veterinary medicinal product in the EU. The purchase of unapproved (veterinary) medicinal products or active pharmaceutical ingredients, such as GS-441524, for example, via the internet, constitutes a violation of the Austrian Medicines Import Act.
Safety warnings
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Blood & Tissue
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09/12/2025
The French authorities have informed the Federal Office for Safety in Health Care that, in addition to the regions already announced, confirmed human WNV infections have been recorded in the département of Corse du Sud.
Safety warnings
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Blood & Tissue
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05/12/2025
The donor/the donor gametes have been permanently blocked.
05/12/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank European Sperm Bank ApS darüber informiert wurde, dass bei dem Spender eine einfache Schizophrenie diagnostiziert wurde.
Der Spender/die Spendergameten wurden permanent gesperrt.
Referenced at:
Safety warnings
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Blood & Tissue
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05/12/2025
The Federal Office for Health Safety has been informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed autochthonous cases of dengue fever have been recorded in the Haute-Garonne department in France.
Trimethoprim (Mono) New
Additional template
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04/12/2025
Further information regarding SmPC harmonisation are available in Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) Minutes for the meeting on 14-15 October 2025.