Official announcements
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
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.
Safety warnings
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Blood & Tissue
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10/12/2025
The Federal Agency 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, confirmed autochthonous cases of Chikungunya have been reported in Bellaria-Igea Marina (province of Rimini) in Italy.
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.
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.
Safety warnings
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Blood & Tissue
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03/12/2025
The Italian authorities have informed the Federal Office for Safety in Health Care (BASG) that, following the lifting of seasonal measures for donor selection, two human WNV infections occurred again in Italy on 2 December. As a result, ID WNV NAT testing for blood and blood component donations has been reintroduced in the province of Naples (Campania region).
Medical devices
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02/12/2025
The BASG has announced that the first four modules of the European Database on Medical Devices (EUDAMED) will be mandatory to use as from 28 May 2026.