Official announcements
Safety warnings
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messages in brief
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03/08/2018
The European Medicines Agency (EMA) is currently conducting an investigation into the potential health effects on patients who have taken valsartan medicines containing the impurity NDMA. NDMA is an impurity found in the active ingredient valsartan,…
Safety warnings
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Medicines
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03/08/2018
Preliminary risk assessment of NDMA for patients
messages in brief
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30/07/2018
New versions of the electronic Application Forms (eAF v. 1.23) and related documents are available via the EMA-website ( http://esubmission.ema.europa.eu/eaf/ ). Specific information from the BASG are published on…
Safety warnings
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Blood & Tissue
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25/07/2018
The Federal Office for Public Health Safety has been informed by the Romanian authority that, in addition to the regions already announced, three confirmed human WNV (meningitis/encephalitis) infections have occurred in the regions of Dolj and Lasi.
Recall
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Veterinary Medicines
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24/07/2018
Richter Pharma AG" as distributor of the veterinary medicinal product "Doxapram-V", which is approved in Germany, has informed its customers that batch 0617569AA is being recalled by the marketing authorization holder "Albrecht GmbH". The reason is a…
Safety warnings
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Blood & Tissue
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23/07/2018
The Federal Office for Safety in Health Care was informed by the Hungarian authority that two confirmed human WNV infections occurred in Perkata (Fejèr County) and in Balatonfüred (Veszprèm County).
Safety warnings
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Blood & Tissue
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19/07/2018
The Federal Office for Safety in Health Care has been informed by the Italian authority that WNV NAT positive mosquito pools have been identified in the regions of Verona, Padua and Rovigo (Veneto Region).
For this reason, ID WNV NAT testing is performed for donors of blood and blood components in these regions.
Safety warnings
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Medical devices
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18/07/2018
The BASG has been approved by the competent authority in Great Britain (Medicines & Healthcare products
Regulatory Agency - MHRA) informs that the products listed are unlawfully available on the market.
were brought. The manufacturer has not provided sufficient evidence that the products comply with the
comply with legal requirements.
Recall
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Medicines
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06/07/2018
The marketing authorization holder informed its supplied customers in a letter dated 06.07.2018 that a production-related contamination of the active ingredient was detected. The substance in question is N-nitrosodimethylamine (NDMA). Therefore, a…
Recall
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Medicines
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06/07/2018
In a letter dated July 6, 2018, the marketing authorization holder informed its customers that a production-related contamination of the active ingredient has been detected. Therefore, a precautionary recall of all batches of "Valsartan Sandoz…