What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Safety warnings
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Blood & Tissue
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29/08/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the French authorities that a confirmed autochthonous case of chikungunya has been recorded in La Réunion (Oversea Department; town: Saint Gilles les Bains).
CHMP Monthly News
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29/08/2024
Up-to-date information from the 24.06.-27.06.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
29/08/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der französischen Behörde mitgeteilt, dass ein bestätigter autochthoner Chikungunya-Fall in La Réunion (Oversea Department; Stadt: Saint Gilles les Bains) verzeichnet wurde.
Referenced at:
29/08/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der kroatischen Behörde mitgeteilt, dass in Kroatien, zusätzlich zu der bereits bekannt gegebenen Region, in der Region Sisak-Moslavina (Sisak und Petrinja) humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Posaconazole New
PSUR-outcome
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23/08/2024
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.
Recall
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21/08/2024
Clinical investigations with medical devices Regulation on electronic submission Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigat
Atorvastatin New
PSUR-outcome
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19/08/2024
Further information and amendments to the product information can be found on the EMA website.
Bumetanide New
PRAC signal recommendation
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14/08/2024
Risko for toxic epidermal necrolysis and Stevens-Johnson syndrome. Further information and amendments to the product information can be found on the EMA website.
Acetazolamide New
PRAC signal recommendation
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14/08/2024
Pulmonary oedemas. Further information and amendments to the product information can be found on the EMA website.