What's new
Information from the previous month appears monthly in “What'sNew” (link to registration page).
For the RSS feed with daily notifications of updates, use the link: RSS feed for “what's new”.
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Fluoroquinolones (for systemic and inhalation use) New
PSUFU
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08/11/2024
Further information is available on the hma-Website.
5_Fluorouracil (iv use) New
PSUR-outcome
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08/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Safety warnings
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Blood & Tissue
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07/11/2024
The Federal Office for Safety in Health Care has been informed by the Greek authority that, in addition to the regions already announced, confirmed human WNV infections have been recorded in western Attica in Greece.
07/11/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der griechischen Behörde mitgeteilt, dass in Griechenland, zusätzlich zu den bereits bekannt gegebenen Regionen, in Westattika bestätigte humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Amantadine New
PSUR-outcome
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30/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
valproic acid and derivates New
PSUR-outcome
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29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Macrogol 3350- combinations (oral use) New
PSUR-outcome
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29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Allopurinol New
PSUR-outcome
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29/10/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Medroxyprogesterone acetate (MPA) New
PRAC signal recommendation
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08/10/2024
Risk for Meningioma. Further information and amendments to the product information can be found on the EMA website.
14/11/2024
Referenced at: