Official announcements
messages in brief
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19/11/2018
To summarize legal provisions, requirements regarding content as well as information how to submit and handle Mock-Ups a new Guidance Document was set up, which can be found under…
Recall
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Veterinary Medicines
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15/11/2018
The marketing authorization holder has informed its supplied customers in a letter dated 13.11.2018 that the above batch is being recalled as a precautionary measure due to a reduced active ingredient content.
Recall
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Veterinary Medicines
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14/11/2018
Richter Pharma AG" as distributor of the veterinary medicinal product "Doxapram-V", which is approved in Germany, has informed its customers that the batches 1216836AA and 1216836AB are recalled by the marketing authorization holder "Albrecht GmbH".…
Recall
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Medicines
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13/11/2018
The marketing authorization holder has informed its supplied customers by letter dated Nov. 12, 2018, that due to a slightly increased exceedance of the specification for known impurities, the above batch is being recalled.
Safety warnings
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Medicines
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25/10/2018
No acute danger, recall purely as a precautionary measure
Safety warnings
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messages in brief
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25/10/2018
Situation in Austria: The Federal Office for Safety in Health Care has received information that several packages of the drug Jakavi 15 mg tablets, for which there is an urgent suspicion of counterfeiting, have entered the legal distribution chain as…
Safety warnings
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Blood & Tissue
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22/10/2018
The Federal Office for Safety in Health Care has been informed by the Italian authority that (in addition to the regions already announced) in Barletta-Andria-Trani (Apulia Region), due to the detection of WNV NAT positive horses, ID WNV NAT testing has been introduced for donors of blood and blood components.
Safety warnings
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Blood & Tissue
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18/10/2018
The Federal Office for Public Health Safety has been notified by the Spanish authority that two human autochthonous cases of dengue virus infection have occurred in Spain.
Safety warnings
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Blood & Tissue
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16/10/2018
The Federal Office for Public Health Safety has been informed by the Italian authority that confirmed human WNV cases have occurred in Genoa (Liguria Region) and in Asti (Piemonte Region), in addition to the regions already announced.
Safety warnings
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Blood & Tissue
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15/10/2018
The Federal Office for Public Health Safety has been informed by the French authority that, in addition to the already known regions, further confirmed human WNV infections (meningitis/encephalitis) have occurred in the Pyrénées-Orientales region.