What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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13/07/2026
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der griechischen Behörde mitgeteilt, dass in Griechenland, in den Regionen Athen-Nord und Ostattika bestätigte humane WNV-Infektion verzeichnet wurde.
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X-ray contrast agents New
PRAC signal recommendation
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08/07/2026
Risk for fixed drug eruption. Further information and amendments to the product information can be found on the EMA website.
Valproate and related substances New
PRAC signal recommendation
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08/07/2026
Risk for neurodevelopmental disorders with paternal exposure. Further information and amendments to the product information can be found on the EMA website.
Gemcitabine New
PRAC signal recommendation
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08/07/2026
Risk for drug reaction with eosinophilia and systemic symptoms (DRESS). Further information and amendments to the product information can be found on the EMA website.
06/07/2026
Transfer of ownership Transfer of ownership - Transfer of title for a marketing authorisation/registration from the current marketing authorisation/registration holder to a new one New AFTER authorisa
Pancreatin New
PRAC signal recommendation
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24/06/2026
Risk for infection due to viral transmission. Further information and amendments to the product information can be found on the EMA website.
Metronidazole / neomycin / nystatin New
PSUR-outcome
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05/06/2026
Further information and amendments to the product information in all EU languages are available on the EMA website.