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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CHMP Monthly News
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21/11/2023
Up-to-date information from the 06.11.-09.11.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Safety warnings
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Medical devices
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09/11/2023
Medtronic Notification of Stolen Defective Products – Potentially Defective McGRATH™ MAC Video Laryngoscopes
NOTE: McGRATH™ MAC video laryngoscopes purchased directly from Medtronic or via its authorized distributors are not affected by this safety notice.
The BASG strongly recommends that medical devices should only be purchased through trusted distribution channels.
CHMP Monthly News
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30/10/2023
Up-to-date information from the 09.10.-12.10.2023 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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30/10/2023
The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that sperm donor 25308 BAO has been diagnosed with muliple sclerosis.
Safety warnings
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Enforcement
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19/10/2023
The Federal Office for Safety in Health Care (BASG) informs about new developments concerning counterfeits of the medicinal product Ozempic® (manufacturer: Novo Nordisk A/S). The existing BASG warnings of 12/10/2023, 19/10/2023 and 23/10/2023 remain valid. The manufacturer's mailing is supplemented with comprehensive patient information.
Safety warnings
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messages in brief
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12/10/2023
BASG informs about current developments and necessary measures in case of counterfeiting of the medicinal product Ozempic® in German presentation.
CHMP Monthly News
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26/09/2023
Up-to-date information from the 11.09.-14.09.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.
Safety warnings
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Blood & Tissue
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06/09/2023
The Federal Office for Safety in Health Care was informed by the Cypriot authority that a WNV infection was recorded in a blood donor by NAT testing in Cyprus.
Enforcement
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31/08/2023
The BASG warns against the products „StartLife StartDetox Mixed Herbal Powder“, „StartLife Coffee Life“, „StartLife Hagebuttenkräutertee“ and „StartLife Zitronenkräutertee“ due to the non-declaration of the ingredient sibutramine.
messages in brief
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21/08/2023
On Friday 18.8.2023 a delegation of the Chinese Drug Administration Zhejiang Medical Products Administration visited the AGES Medical Market Surveillance for an exchange and deeper insights into the fields of activity.