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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02/09/2024
The Federal Office for Safety in Health Care would like to draw your attention to the current assessment of the ECDC (European Center for Disease Prevention and Control) on Mpox.
CHMP Monthly News
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30/08/2024
Up-to-date information from the 22.07.-25.07.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
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.
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.
Safety warnings
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Blood & Tissue
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23/08/2024
The Federal Office for Safety in Health Care (BASG) has been informed by the Italian authorities that a confirmed human dengue case has been recorded in Albinea (province of Reggio Emilia, Emilia-Romagna region).
messages in brief
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30/06/2024
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Safety warnings
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Veterinary Medicines
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19/06/2024
Important information from the Federal Office for Safety in Health Care concerning the suspension of the marketing authorization and the recall of all batches of the veterinary medicinal product "Kexxtone 32.4 g continuous-release intraruminal device for cattle. Monensin"
Safety warnings
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Medical devices
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13/06/2024
The manufacturer Bioteck S.p.A. of the CE-marked medical device CHONDROGRID® informs that counterfeits of this product have been found in Turkey.
messages in brief
CHMP Monthly News
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10/06/2024
Up-to-date information from the 27.05.-30.05.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
messages in brief
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20/05/2024
After a review process lasting almost a year, the WHO decided on 14.05.2024 to include the European network of EU and EEA medicines authorities, of which the Federal Office for Safety in Health Care is an essential and active part, as a recognized "regional entity" in the list of WHO Listed Authorities (WLA) for human medicines and vaccines.