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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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28/08/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der spanischen Behörde mitgeteilt, dass in Spanien, zusätzlich zu den bereits bekannt gegebenen Regionen, in der Provinz Huelva (Region Andalusien) sowie in der Provinz Badajoz (Region Extremadura) bestätigte humane WNV-Infektionen verzeichnet wurden.
Referenced at:
Safety warnings
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Blood & Tissue
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27/08/2024
The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank (DK257572) that an offspring of the sperm donor 25297/TROHN carries a pathogenic variant of the ATM gene. Genetic testing of the donor identified the ATM variant in a heterozygous state.
The donor/the donor gametes were permanently blocked.
27/08/2024
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank European Sperm Bank (DK257572) darüber informiert wurde, dass ein Nachkomme des Samenspenders 25297/TROHN eine pathogene Variante des ATM-Gens trägt. Bei der genetischen Untersuchung des Spenders wurde die ATM-Variante in heterozygotem Zustand identifiziert.
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.
Minoxidil (topical formulation) New
PSUR-outcome
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14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Clevidipine New
PSUR-outcome
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14/08/2024
Further information and amendments to the product information can be found on the EMA website.