Official announcements
Safety warnings
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Blood & Tissue
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03/06/2015
The Federal Office for Public Health Safety has been informed by the European Centre for Disease Prevention and Control (ECDC) of the first documented outbreak of ZIKA virus infection in Brazil and in some Pacific Islands (Vanuatu, Solomon Islands, New Caledonia).
Recall
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Medicines
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02/06/2015
The parallel distributor has informed its supplied customers in a letter dated June 2, 2015, that the affected batch A229473D is being recalled due to a falsification of the packaging. The marketing authorization holder "Gilead Sciences International…
messages in brief
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28/05/2015
Situation in Austria As of June 25, 2015, remote sales of over-the-counter pharmaceutical specialties approved in Austria will be made possible. Interested domestic, public pharmacies can register for this with immediate effect. more information:…
Recall
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Medicines
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28/05/2015
The marketing authorization holder has informed its supplied customers that a slightly increased level of oxidized methionine was found in stability tests after 12 months of storage. Methionine is part of the structure of erythropoietin, and…
Safety warnings
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Blood & Tissue
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25/05/2015
This is the first documented outbreak of Zika virus (ZIKV) infection in Brazil and in the Americas.
Recall
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Medicines
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21/05/2015
Sandoz GmbH has informed all supplied customers in a letter dated 20.05.2015 that deviations in the release of the active ingredient were found in stability tests for batches with the old shelf life of 36 months. These deviations are due to the aging…
Safety warnings
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Blood & Tissue
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21/05/2015
This is the first chikungunya case reported from Spain without travel history to endemic areas. The infection occurred most likely in the city of Gandía, Valencia community. The case developed symptoms on 7 July while travelling in France.
Safety warnings
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messages in brief
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12/05/2015
Measures at EU level The European Medicines Agency (EMA) would like to increase the acceptance of participation of children and adolescents in clinical trials. To this end, a questionnaire has been designed that is aimed at children and adolescents…
Safety warnings
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messages in brief
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28/04/2015
The Federal Office informs about recommendations of the European Medicines Agency EMA regarding a restriction of the use of new hepatitis C drugs together with amiodarone. Measures at EU level The European Medicines Agency (EMA) has confirmed that…
Recall
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Medicines
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02/04/2015
The distribution company informed its supplied customers by letter dated 01.04.2015 that various finished product batches from a single bulk are being recalled because black visible particles were detected.