Official announcements
Safety warnings
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Blood & Tissue
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19/12/2017
The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Cryos International ApS (DK257551) about the disease of a child conceived with the semen of sperm donor 5971.
messages in brief
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06/12/2017
AGES MEA experts took the rapporteur role for the development of the new EMA document: "Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development" (EMA/CHMP/138502/2017). Over the past 2.5…
Recall
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Medicines
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28/11/2017
The marketing authorization holder informed its supplied customers in a letter dated 27.11.2017 that the stability test did not comply with the test for gastric juice resistance. The potential impact on patient safety is assessed as low. All other…
Recall
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Medicines
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24/11/2017
The distribution partner for the marketing authorization holder, "DSD Pharma GmbH", informed its supplied customers in a letter dated November 15, 2017, that the qualified person for batch 171115FDG01 has not issued a batch release and that the batch…
Recall
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Medicines
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23/11/2017
The marketing authorization holder has informed its supplied customers in a letter dated 22.11.2017 that deviations from the microbial limit values were detected in a batch marketed abroad. As a precautionary measure, all batches that were produced…
Recall
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Medicines
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08/11/2017
The marketing authorization holder informed its supplied customers in a letter dated November 8, 2017, that a production-related crack at the valve connection seal to the bag may occur in "Physioneal Clear-Flex bags". On the one hand, the crack could…
messages in brief
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07/11/2017
As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good…
Safety warnings
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Blood & Tissue
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30/10/2017
The Federal Office for Safety in Health Care was informed by the Danish authority that it was informed by the Danish tissue bank Nordic Cryobank ApS - NCB - (European Sperm Bank) about a microduplication in the PAR1 regionXp22.33/Yp11.32 in sperm donor 8040/ADLER. The duplication was verified by multiplex ligation-dependent probe amplification(MLPA; probemix P018-G1 SHOX, MRC-Holland). The duplication does not involve the SHOX gene but is located downstream in the regulatory region.
Safety warnings
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Blood & Tissue
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25/10/2017
The Federal Office for Public Health Safety has been informed by the French authority that the first human WNV infection has been confirmed in Nice. Therefore, the French authority extends the seasonal WNV surveillance until November 15, 2017.
Safety warnings
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Blood & Tissue
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09/10/2017
Italy is currently experiencing four clusters of autochthonous chikungunya cases in the cities of Anzio, Latina and Rome in the Lazio region, and the city of Guardavalle Marina in the Calabria region.
Autochthonous transmission of mosquito-borne infections is not unexpected in areas where Aedes albopictus mosquitoes are established and at a time when environmental conditions are favouring mosquito abundance and activity.