What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Safety warnings
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Blood & Tissue
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08/09/2025
The Federal Office for Safety in Health Care was informed by the ECDC (European Centre for Disease Prevention and Control) that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Bács-Kiskun, Hungary.
08/09/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass in Ungarn, zusätzlich zu den bereits bekannt gegebenen Regionen, in Bács-Kiskun bestätigte humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Safety warnings
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Blood & Tissue
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08/09/2025
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 Hérault department in France.
08/09/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass in Frankreich, zusätzlich zu den bereits bekannt gegebenen Regionen, bestätigte autochthone Dengue-Fälle im Département Hérault verzeichnet wurden.
Referenced at:
Safety warnings
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Blood & Tissue
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05/09/2025
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 department of Auvergne Rhone Alpes, in France.
05/09/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der französischen Behörde mitgeteilt, dass in Frankreich, zusätzlich zu den bereits bekannt gegebenen Regionen, in dem Département Auvergne Rhone Alpes bestätigte humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Safety warnings
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Blood & Tissue
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04/09/2025
The Federal Office for Safety in Health Care has been informed by the Greek authorities that, in addition to the regions already announced, confirmed human WNV infections have been recorded in Achaia, Aetoloakarnania, Arta and Corinth, in Greece.
Safety warnings
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Enforcement
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04/09/2025
In recent months, the number of illegal drugs marketed for weight loss has risen sharply.
Clozapine New
PRAC signal recommendation
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03/09/2025
New aspect of the known risk of neutropenia/agranulocytosis with potential impact on the risk minimisation measures. Further information and amendments to the product information can be found on the EMA website.
Varicella vaccine (live); measles, mumps, rubella and varicella vaccine (live) New
PRAC signal recommendation
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02/09/2025
New aspect of the known risk of encephalitis. Further information and amendments to the product information can be found on the EMA website.