What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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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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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.
Safety warnings
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Blood & Tissue
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02/09/2025
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that human WNV infections have been recorded in Berat and Elbasan, Albania.
02/09/2025
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der ECDC (European Centre for Disease Prevention and Control) mitgeteilt, dass in Albanien, in Berat und Elbasan humane WNV-Infektionen verzeichnet wurden.
Referenced at:
01/09/2025
Hämovigilanzbericht 2020 Hämovigilanz-Bericht 2024 2/53 Inhalt Inhalt .................................................................................................................. 2 Abbildungsver
Referenced at:
Finasteride or Dutasteride New
Referral
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01/09/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
01/09/2025
Freedom of information New General information Proactive information from the BASG Procedure for the authorisation of medicinal products Adverse reaction reports of medicinal products for human use Ad
Stiripentol New
PSUR-outcome
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27/08/2025
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.