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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Searched for bundesamt fur sicherheit im gesundheitswesen.
messages in brief
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10/11/2020
Keine Wirkung gegen COVID-19 und begründeter Verdacht auf schädliche Wirkungen.
messages in brief
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24/06/2020
Die Warnung umfasst Produkte die außerhalb von legalen Apotheken angeboten werden
Enforcement
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06/04/2017
European directives relating to medicinal products have to be transposed into national law by the member states. A certain flexibility of this transposition is aimed at the optimal implementation of European requirements into national standards in order to provide for global European interests such as high-quality health care. This relative “legislational freedom” often results in national legal differences, as for example the so-called “Eigenherstellung” or “Individual small scale contract production” of medicinal products by physicians. Which is not allowed in Austria but licit in some states of the European Union like the Federal Republic of Germany.
messages in brief
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30/11/2016
EU Regulation 536/2014 is expected to standardize the approval procedure for clinical trials throughout the EU from fall 2018. These are an essential part of drug development and, not least, provide objective proof of the effect and side effects of…
messages in brief
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07/11/2016
AGES Medical Market Surveillance launches a social media campaign from November 7 - 11, 2016 to increase willingness to report adverse reactions. Vienna (OTS) - In addition to positive effects, medicinal products can also have potential side effects.…
Safety warnings
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Medicines
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06/09/2016
Novo Nordisk is recalling 55 lots of GlucaGen HypoKit worldwide because in some cases the needle has come loose from the pre-filled syringe. In Austria, one batch is affected.
Recall
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Medicines
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16/10/2012
The marketing authorization holder, in consultation with the French authority, informed its supplied customers by letter dated 10/10/2012 that batch C079 is being recalled because it has a different volume/activity indication on the bottle label…
Recall
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Veterinary Medicines
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25/07/2012
The marketing authorization holder informed its supplied customers by letter dated July 12, 2012, that batches 20528D and 20532E are to be blocked immediately. The recall of these batches was initiated by letter dated 18.07.2012. The recall was…
Recall
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Veterinary Medicines
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23/12/2011
The marketing authorization holder has informed its supplied customers by telephone that the above batch was delivered with Dutch labeling.
Recall
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Medicines
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22/12/2011
In a letter dated December 12, 2011, the distribution partner informed the institutional pharmacies supplied that the marketing authorization holder was recalling those batches of "Velcade" that were produced at the manufacturer Ben Venue…