What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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22/10/2025
Quality Management New The quality system of the Austrian federal Office for Safety in Health Care is operated by the Austrian Medicines and Medical Devices Agency and implements the requirements of I
Recall
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Veterinary Medicines
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21/10/2025
Recall due to particles in the injection solution
21/10/2025
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 Seine Maritime bestätigte humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Levetiracetam New
PSUR-outcome
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15/10/2025
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.
09/10/2025
Beilage zum Bescheid GZ.: 2025-0.760.858 65 Konformitätsbewertungsverfahren 1 von 10 Prüflaboratorium Rechtsperson: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Spargelfeldstra
Referenced at:
09/10/2025
Die Nationale Akkreditierungsstelle / The National Accreditation Body: AKKREDITIERUNG AUSTRIA bestätigt die Akkreditierung der Rechtsperson / confirms the accreditation of Österreichische Agentur für
Referenced at:
Diamorphine New
PSUR-outcome
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03/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Diazoxide New
PRAC signal recommendation
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30/09/2025
Risk for necrotising enterocolitis neonatal. Further information and amendments to the product information can be found on the EMA website.
Hydromorphone New
PSUR-outcome
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15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phosphocreatine New
PSUR-outcome
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15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.