Official announcements
Recall
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Medicines
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26/04/2019
"MEDIKUS medizintechnische und pharmazeutische Vertriebs GmbH" informed its customers on April 26, 2019 that metallic particles were detected in the infusion bags.
Enforcement
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26/04/2019
Amygdalin-containing veterinary drugs can cause severe side effects
messages in brief
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24/04/2019
Article 54 of the MDR regulates the consultation procedure related to the clinical evaluation of certain class III and class IIb devices. Regarding the exemption provisions to this procedure, an interpretative document has been published. Devices…
messages in brief
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23/04/2019
The purpose of the ‚Draft guideline on the non-clinical requirements for radiopharmaceuticals‘ (EMA/CHMP/SWP/686140/2018) is to provide guidance on the required nonclinical data needed to support clinical development and marketing authorisation of…
Safety warnings
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Blood & Tissue
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17/04/2019
Only available in German
Safety warnings
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Blood & Tissue
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17/04/2019
Only available in German
Safety warnings
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Blood & Tissue
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17/04/2019
Only available in German
Safety warnings
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Blood & Tissue
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09/04/2019
Only available in German
Enforcement
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06/04/2019
Great hopes of physicians as well as patients are attached to stem cell and other cell-based therapies. Major progress is expected particularly in the areas of difficult-to-treat and chronic diseases. In order to prevent hope to be transformed into a “trade with hope”, it is important for authorities to monitor this new therapeutic area.
